Info Source: Sources of Federal Government and Employee Information Health Canada

Update: 2023

Info Source: Sources of Federal Government and Employee Information provides information about the functions, programs, activities and related information holdings of government institutions subject to the Access to Information Act and the Privacy Act. It provides individuals and employees of the government (current and former) with relevant information to access personal information about themselves held by government institutions subject to the Privacy Act and to exercise their rights under the Privacy Act.

The Introduction and an index of institutions subject to the Access to Information Act and the Privacy Act are available centrally.

The Access to Information Act and the Privacy Act assign overall responsibility to the President of Treasury Board (as the designated Minister) for the government-wide administration of the legislation.

Table of Contents

General Information

Background

Health Canada was established in 1996 through the Department of Health Act. It is the federal department responsible for helping Canadians maintain and improve their health. Health Canada is committed to improving the lives of all Canadians and to making this country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system.

On an annual basis, the federal Minister of Health is required to report to Parliament on the administration and operation of the Canada Health Act, as set out in section 23 of the Act. The vehicle for so doing is the Canada Health Act Annual Report. While the principal and intended audience for the Report is Parliamentarians, a public document offers a comprehensive report on insured services in each of the provinces and territories. The Annual Report is structured to address the mandated reporting requirements of the Act; as such, its scope does not extend to commenting on the status of the Canadian health care system as a whole. (Source: Health Canada)

For more information, please consult About Health Canada.

Responsibilities

Health Canada has many roles and responsibilities that help Canadians maintain and improve their health. Health Canada's mandate is to improve the lives of all Canada's people and to make the country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system.

First, as a regulator, Health Canada is responsible for the regulatory regime governing the safety of products including food, pharmaceuticals, medical devices, natural health products, consumer products, chemicals, radiation emitting devices, cosmetics and pesticides. It also regulates tobacco products and controlled substances, public health on aircraft, ships and other passenger conveyances, and helps manage the health risks posed by environmental factors such as air, water, radiation and contaminants.

In 2018, Health Canada transferred service provider responsibilities for First Nations to the newly created Indigenous Services Canada. The federal government has provided basic health services to First Nations since 1904. Today, the federal government provides basic primary care services in approximately 200 remote First Nations communities, home and community care in 600 First Nations communities, support for health promotion programs in Inuit communities across four regions and a limited range of medically-necessary health-related goods and services not insured by private or other public health insurance plans to eligible First Nations and Inuit. The government funds or delivers community-based health programs and public health activities to First Nations and Inuit. These activities promote health, prevent chronic disease and address issues such as substance abuse and the spread of infectious diseases.

Health Canada is a catalyst for innovation, a funder, and an information provider in Canada's health system. It works closely with provincial and territorial governments to develop national approaches on health system issues and promotes the Pan-Canadian adoption of best practices. It administers the Canada Health Act, which embodies national principles to ensure a universal and equitable publicly funded health care system. It provides policy support for the federal government's Canada Health Transfer to provinces and territories, and provides funding through grants and contributions to various organizations to help meet Health Canada's objectives. Lastly, the department draws on leading-edge science and policy research to generate and share knowledge and information to support decision-making by Canadians, development and implementation of regulations and standards, and health innovation.

Institutional Functions, Programs and Activities

Health Care Systems

Health Canada provides national leadership to foster sustainable health care systems that ensure access for Canadians to appropriate and effective health care.

Access, Affordability, and Appropriate Use of Drugs and Medical Devices

The policy advice provided by Health Canada is instrumental in advancing the accessibility, affordability and appropriate use of drugs and medical devices. The contribution to the Canadian Agency for Drugs and Technologies in Health (CADTH) supports the federal government's interest in achieving an accessible, high quality, sustainable and accountable health system adaptable to the needs of Canadians. CADTH works to provide health care decision-makers with credible, impartial advice and evidence-based information about the cost-effective and appropriate use of drugs and medical devices by producing Health Technology knowledge products, conducting drug and non-drug reviews/assessments and knowledge mobilization and outreach. Target populations that influence and benefit from the work of CADTH include federal, provincial and territorial governments drug plans and Ministries of Health, regional health authorities, clinicians and patients. CADTH consults and collaborates with a network of stakeholders to ensure its activities meet their needs, including federal, provincial and territorial governments and drug plan managers; health care leaders and decision makers; regional health authorities; patients; researchers and other health technology assessment producers; pan-Canadian organizations; national professional associations; national specialty societies; and private industry.

Access, Affordability, and Appropriate Use of Drugs

Description: Includes records related to the access, affordability, and use of drugs in Canada; and to the Canadian Agency for Drugs and Medical Devices in Health.

Document Types: correspondence, memoranda, grants and contributions agreements, complaints, consultation, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC AAA 005

Brain Research

With an aging population and increased rate of brain diseases/disorders, the Government of Canada acknowledges the importance of enhancing the health care system through the advancement of brain research. In support of the Health Care Systems Core Responsibility, the Program supports Canadian brain research in order to develop a better understanding of the underlying mechanisms responsible for brain diseases/disorders through innovative brain research partnerships with Canadian federal granting agencies (i.e., Canadian Institutes of Health Research Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council). Administered by the Brain Canada Foundation, federal government funding is equally matched by non-federal funding sources.

Brain Research

Description: Includes records related to the support of brain research in Canada through partnerships with federal granting agencies.

Document Types: correspondence, memoranda, grants and contributions agreements, consultation, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC BR 005

Canada Health Act

The Canada Health Act (CHA) is Canada's federal legislation for publicly funded health care insurance. The aim of the Act is to facilitate reasonable access to insured health care services without financial or other barriers. The administration of CHA involves monitoring a broad range of sources to assess the compliance of provincial and territorial health insurance plans with the criteria and conditions of the Act and working in partnership with provincial and territorial governments to resolve concerns which may arise, the work of the Interprovincial Health Insurance Agreements Coordinating Committee to address issues affecting interprovincial billing of insured services, providing the Minister advice on the administration and interpretation of the Act on issues of non-compliance and recommend appropriate action when required, and reporting to Parliament on the administration of the Act.

Administration of the Canada Health Act

Description: Includes records related to the administration of the Canada Health Act, involving monitoring to assess compliance; collaboration with provincial and territorial governments; development of policy advice; and reporting to Parliament via that Canada Health Act Annual Report (CHAAR) on the administration of the Act and; Secretariat services for the provincial/territorial Interprovincial Health Insurance Coordinating Committee (IHIACC).

Document Types: correspondence, memoranda, complaints, consultation, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, annual report to Parliament, contracts with collaborators, grants and contribution proposal documentation, information sharing agreements.

Record Number: HC CHS 010

Consultation on Health Protection Legislation

Description: This bank contains the names and addresses of persons to whom documents are mailed from time to time for consultations purposes or of persons who have provided their views and opinions on the renewal of federal health protection legislation.

Class of Individuals: Private citizens with an interest in health protection, public interest groups, health institutions, health professionals, representatives of all levels of government, members of federal departments, members of the industry, Canadian corporations and other interested parties.

Purpose: To create a mailing list and tracking system for consultation and follow-up purposes in the process of renewing Canada's health protection legislation, and for other consultations relating to the health protection program.

Consistent Uses: None

Retention and Disposal Standards: The retention period is being re-negotiated with Library and Archives Canada. Until a new agreement is reached, the current agreement remains: Records of individual replies will be retained for ten years then Library and Archives Canada will review for archival interest.

RDA Number: 2015/022

Related Record Number: HC CHS 010

TBS Registration: 004115

Bank Number: HC PPU 051

Cancer Control

The federal government recognizes the burden of cancer on both personal and societal levels. Health Canada supports cancer control through the Canadian Partnership Against Cancer (CPAC). Established in 2007, CPAC is an independent, not-for-profit organization with the mandate of reducing the number of cancer cases in Canada, minimizing the number of cancer-related deaths, and improving patient quality of life. It seeks to accelerate action on cancer control for all Canadians by augmenting, building upon and implementing the multi-tiered Canadian Strategy for Cancer Control (CSCC). CPAC works to ensure that the most reliable and current cancer knowledge reaches governments, cancer professionals, support groups, patients and their families, and individuals in all parts of the country. Budget 2016 confirmed ongoing funding for CPAC at $47.5 million per year. This will allow the organization to continue its work with cancer agencies and stakeholders, while engaging patients, care providers and the general public in promoting innovative approaches to reducing the toll of cancer across Canada. CPAC's expected outcomes contribute to supporting the Health Care Systems Core Responsibility.

Cancer Control

Description: Includes records related to the support of cancer control in Canada and to the Canadian Partnership Against Cancer.

Document Types: correspondence, memoranda, grants and contributions agreements, consultation, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC DH 005

Digital Health

The federal government recognizes the importance of improving health care systems through the implementation of digital health technologies. The policy advice provided by Health Canada is instrumental in advancing the uptake of innovative health solutions. In addition, since 2001, the Government of Canada has invested a total of $2.45 billion in Canada Health Infoway to accelerate the development, adoption and effective use of digital health care across Canada. Most recently, investment in Infoway was made to expand e-prescribing and virtual care initiatives, support the continued adoption and use of electronic medical records, help patients to access their own health records electronically, and better link electronic health record systems to improve access by all providers and institutions. This funding will advance pan-Canadian collaboration on health innovation to encourage the adoption of new digital health technology to improve access, increase efficiency and improve outcomes for patients. Infoway will work with provincial and territorial governments, health care organizations, health professional associations, retail pharmacies, technology vendors, patients, and caregivers to advance the identified digital health priorities.

Digital Health

Description: Includes records related to digital health care across Canada and to Canada Health Infoway.

Document Types: correspondence, memoranda, complaints, grants and contributions agreements, consultation, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC DH 005

Health Care Systems Analysis and Policy

Health Canada works in close collaboration with the provinces and territories, health professionals, and other key stakeholders to develop strategic policy advice on health care. Our aim is to ensure that health care policy decisions are based on strong evidence and are aligned with the principles of equity, sustainability, and affordability. The Department supports innovative partnerships with Pan-Canadian organizations and other stakeholders to meet current and future health care systems challenges. Health care systems analysis and policy activities address issues related to broader health care systems renewal, such as the implementation of the Health Accord, fiscal transfers, health care financing, governance and accountability, and the roles and interface of the public and private sectors. Our work related to health care systems analysis and policy is supported by the following activities with specific performance measurement strategies: the Health Accord; the Health Care Policy Contribution Program; and Canadian Foundation for Healthcare Improvement.

Health System Priorities

Description: Includes records related to policy and program leadership for health system priorities, particularly collaboration with provincial and territorial governments, health care providers and other stakeholders. Includes grants and contributions relating to the administration of the Canadian Thalidomide Survivors Contribution program; and federal investments in national shared-governance entities and targeted federal programs, including, but not limited to, health information, accountability, cost-effectiveness of drugs, patient safety, cancer and mental health.

Document Types: draft policies, correspondence, memoranda, public relations materials, presentations, contracts with collaborators, grants and contribution proposals, agreements and documentation, information sharing agreements, research proposals, analysis and reports, funding agreements, and evaluations from conferences and/or meetings with provincial and territorial government applications, medical and financial records of applicants, proof of identification, proof of residency, meeting agenda, minutes and reports, briefing notes, public opinion research.

Record Number: HC CHS 005

Home Care Study

Description: This bank contains information pertaining to clients and formal and informal care providers of home care within Ottawa-Carleton. The data consists of a client code, postal code, age, gender, and diagnosis, reason for admission to home care, referral source, mother tongue, living arrangements, and relation to informal care provider. For informal care providers, data include the individual score on the Zarit Caregiver Burden Scale.

Note: The Home Care Study records have been transferred from the Public Health Agency of Canada to Health Canada as of 2017-2018.

Class of Individuals: Formal and informal care providers and clients admitted to the Regional Municipality of Ottawa-Carleton Home Care Program.

Purpose: To gain a better understanding of the factors, which influence access to home care services.

Consistent Uses: Pilot research project only.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC CHS 005

TBS Registration: 20170108

Bank Number: HC PPU 420


Postgraduate Medical Training in the United States

Description: This bank describes information related to Canadian medical graduates and students applying for a Statement of Need, a document required to obtain a J-1 Visa to enter the United States to pursue postgraduate medical training. The personal information may include name, contact information, biographical information, citizenship status, date of birth, educational information, other identification numbers, signature and Educational Commission for Foreign Medical Graduates (ECFMG) number, fellowship status and details, date(s) of previous application.

Class of Individuals: Medical graduates and final year medical students who are Canadian citizens or permanent residents seeking postgraduate training in the United States

Purpose: The personal information is used to issue a Statement of Need, which is a document required to obtain a J-1 Visa to enter the United States to pursue postgraduate medical training. The personal information and Statement of Need is then given to the ECFMG to assist with the evaluation of an application and/or to ensure the Statement of Need is correctly matched with the applicant's visa application. Personal information is collected pursuant to section 4(2)(i) of the Department of Health Act.

Consistent Uses: The information may be used or disclosed for audit and evaluation. When consent is obtained, personal information is disclosed to provincial and territorial governments for recruitment purposes and to the Canadian Post-M.D. Education Registry (CAPER) on an annual basis for the purpose of research on physician resources.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC CHS 005

TBS Registration: 20120404

Bank Number: HC PPU 421


Financial Support Programs for Canadian Thalidomide Survivors

Description:This bank describes information related to the administration of financial support to Canadian thalidomide survivors. This includes Health Canada's Canadian Thalidomide Survivors Support Program (CTSSP) and the 2015 Thalidomide Survivors Contribution Program (TSCP) as well as the 1991 Extraordinary Assistance Plan for victims of thalidomide administered by Health Canada and the Public Health Agency of Canada (PHAC). Personal information may include name, contact information, date of birth, date of death, proof of identification (birth certificate, driver's license, provincial photo ID card and Canadian passport), health status, medical and financial information, as well as decisions on eligibility for federal financial support.

Note: This PIB includes records transferred from PHAC and formerly described in the "Extraordinary Assistance Plan" (EAP) PIB (PHAC PPU 039).

Class of Individuals: Individuals who have applied to or have received financial support from the programs, or deemed eligible for financial support, their legal representative(s), related applicants and individuals who contacted Health Canada about the programs.

Purpose: The personal information is used to determine eligibility, level of support and administer financial support for Canadian thalidomide survivors. The authority to collect personal information is The Department of Health Act S.C. 1996, c.8 sections 4(1) and 4(2).

Consistent Uses: Information contained in these files may be used and/or disclosed within Health Canada and to a third party program manager to administer financial support only. Information (name, address and payment amount) may also be used by and/or disclosed to Public Works and Government Services Canada to prepare payments to survivors, and to provinces/territories to prevent the reduction of financial and health benefits for thalidomide survivors. Refer to "Receiver General Payments" PIB # PWGSC PCU 712.

Retention and Disposal Standards: Records are retained for at least six years after the person is deceased.

RDA Number: 2015/022

Related Class of Record Number: HC CHS 005

TBS Registration: 20180034

Bank Number: HC PPU 422


Monitoring of Medical Assistance in Dying

Description: This bank describes information related to mandatory reporting by physicians, nurse practitioners and pharmacists who receive written requests for, and who provide Medical Assistance in Dying (MAID) or dispense medication for MAID. The personal information collected about physicians, nurse practitioners and pharmacists includes name, contact information, license or registration number, and area of specialization. The personal information collected about patients includes date of birth, date of death (if applicable), gender, province/territory and postal code of residence, health insurance number, and medical information.

Note: Physicians, nurse practitioners, pharmacists, and patient applicants seeking MAID.

Class of Individuals: The personal information is used to administer the Monitoring of Medical Assistance in Dying program. Personal information is collected pursuant to section 241.31(3) of the Criminal Code and the Regulations for the Monitoring of Medical Assistance in Dying SOR/2018-166.

Purpose: The information may be used or disclosed for the following purposes: monitoring activities such as, verifying accuracy and completeness of the data, compliance with reporting requirements and production of annual reports using aggregate-level data. Personal information may be disclosed to Statistics Canada and qualified researchers for statistical purposes. Personal information may be disclosed to provincial/territorial organizations for the purposes of supporting the monitoring of MAID. Pertaining to situations of non-compliance with reporting requirements, personal information may be disclosed to applicable law enforcement, provincial/territorial regulatory bodies or coroner's offices, as permitted by federal authorities on the disclosure of personal information.

Consistent Uses: Records will be destroyed five years after last administrative action.

Retention and Disposal Standards: Records will be destroyed five years after last administrative action.

RDA Number: 2015/022

Related Class of Record Number: HC CHS 005

TBS Registration: 20210002

Bank Number: HC PPU 435

Emergent Health Issues

Description: Includes records relating to transformative and emerging technologies in the area of nanotechnology, assisted human reproduction, genetics, general medicine, and health and food innovation including global supply chains, among other emergent health issues. Records will include strategic policy documents detailing legislative and regulatory frameworks, tools or other approaches as well as documentation in support of collaboration with stakeholders.

Document Types: award applications and supporting documentation, curriculum vitae, research proposals, analysis and reports, correspondence, memoranda, public relations materials, draft policies, presentations, contracts with collaborators, information sharing agreements, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, outreach and engagement materials, submissions from third parties, committee agenda, minutes and reports.

Record Number: HC CHS 015

Health Information

The Government of Canada acknowledges the importance of enhancing health care systems by providing health care information that improves the health of Canadians. Health Canada provides policy advice that is instrumental in delivering comparable and actionable information to accelerate improvements in health care systems. The Canadian Institute for Health Information (CIHI) provides comparable and actionable data and information that are used to accelerate improvements in health care, health system performance and population health across Canada under its present mandate. Target populations include funders and policy-makers (Federal, Provincial and Territorial (FPT) ministries of health; health services organizations, including regional health authorities and local health integration networks, health managers and health professionals); national, provincial and territorial associations and organizations; research and knowledge translation bodies (academic communities, health quality councils, non-governmental organizations, researchers, international bodies); the Canadian public and the private sector. CIHI's operations are designed to align with the priorities of its key stakeholders, including funders and policy-makers at all levels of government, health services organizations, associations and research bodies.

Health Information

Description: Includes records related to enhancing health care systems and the Canadian Institute for Health Information.

Document Types: correspondence, memoranda, complaints, grants and contributions agreements, consultation, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC HI 005

Home, Community and Palliative Care

The Government of Canada is committed to supporting provinces and territories to enhance access to quality home, community and palliative care services for Canadians. Budget 2017 committed to $11 billion over ten years for two shared health priorities: home and community care (including palliative care) and mental health and addictions. In August 2017, federal, provincial and territorial (FPT) governments agreed to common objectives and specific areas of action for these priorities, as set out in the FPT Common Statement of Principles on Shared Health Priorities. The agreed-upon areas of actions for home and community care are: spreading and scaling integrated models of care; enhancing access to palliative care; increasing support for caregivers; and enhancing home care infrastructure. Ongoing home and palliative care policy advice, evidence assessment, and stakeholder engagement support these efforts in the Department. In addition to work with provincial and territorial counterparts to advance pan-Canadian policy direction and a vision for palliative care, in December 2018, the Government released the Framework on Palliative Care in Canada, and Health Canada continues to engage provinces, territories, palliative care providers and Canadians to develop an implementation plan.

Home, Community and Palliative Care

Description: Includes records related to home and palliative care policy advice, evidence assessment, and stakeholder engagement support these efforts in the Department.

Document Types: correspondence, memoranda, complaints, consultation, grants and contributions agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record number: HC HCP 005

Medical Assistance in Dying

On June 17, 2016, legislation was passed to amend the Criminal Code to permit Medical Assistance in Dying (MAID) in Canada. While the federal legislation establishes consistent requirements regarding eligibility for MAID and safeguards regarding its delivery, provinces and territories (PT) are largely responsible for implementation with respect to the administration of health care services, and justice. The legislation identifies responsibilities for the federal government: establishing regulations for a pan-Canadian monitoring and reporting system (implemented in November 2018); publishing guidelines on the certification of deaths in cases of MAID (completed April 2017); and initiation of independent reviews (completed in December 2016/tabled in Parliament in December 2018) on three types of requests not covered by the legislation (by mature minors; advance requests; and requests where mental illness is the sole underlying medical condition). In addition, the federal government seeks to support the coordination of end-of-life care, so that Canadians are informed about MAID and how to access it. Monitoring (including data collection) activities, in particular, require collaboration with PT governments and key stakeholders, and support the legislation's requirement to produce annual public reports on MAID in Canada.

Medical Assistance in Dying

Description: Includes records related to the administration and regulation of medical assistance in dying in Canada.

Document Types: correspondence, memoranda, complaints, consultation, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC MAID 005

Mental Health

The Government of Canada is committed to improving the health care systems by enhancing access to quality mental health services for Canadians. Budget 2017 committed to $11 billion over ten years to expand access to home and community care and mental health and addictions and in August 2017, federal, provincial and territorial (FPT) governments agreed to common objectives and specific areas of action for these priorities, as set out in the FPT Common Statement of Principles on Shared Health Priorities. The areas of action for mental health and addiction services are: expanding access to community-based services for children and youth; spreading evidence-based models of community mental health care and culturally-appropriate interventions; and expanding availability of integrated community-based services for people with complex health needs. Mental health policy advice, evidence assessment, and stakeholder engagement will support these efforts in the Department. Mental health policy advice, evidence assessment, and stakeholder engagement will support these efforts in the Department. Health Canada's policy and program work also includes contributions to the Mental Health Commission of Canada to federal mental health objectives through the development of knowledge products, collaborative partnerships, and mental health literacy training and awareness campaigns.

Mental Health

Description: Includes records related to mental health policy advice, evidence assessment, and stakeholder engagement to support these efforts in the Department.

Document Types: correspondence, memoranda, complaints, consultation, grants and contributions agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HV MH 005

Organs, Tissues and Blood

A safe and effective blood system is a cornerstone of health care delivery. The Organs, Tissues and Blood Program addresses the Health Care Systems Core Responsibility by supporting research that contributes to a safe and effective supply of blood and blood products for Canadians, and by supporting activities that contribute to Canadians' access to safe, effective donations and transplantations of organs and tissues. The entire program is delivered through funding agreements and collaborative initiatives with Canadian Blood Services (CBS), provinces and territories, and other partners. Provincial and territorial governments, which have jurisdictional authority for the delivery of organ donation, and transplantation and the transfusion of blood and blood products, also provide funding to CBS and other partners. While the organs, tissues and blood program component focuses on improving the effectiveness of the system, the blood research and development activities supports protection from health risks associated with the use of biological products through evidence-based practices to ensure the safety and supply of the Canadian blood system.

Organs, Tissues and Blood

Description: Includes records related to the supply of blood and blood products for Canadians, access by Canadians to donations and transplantations of organs and tissues and to Canadian Blood Services.

Document Types: correspondence, memoranda, complaints, consultation, grants and contributions agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC OTB 005

Compliance and Enforcement - Biologics & Radiopharmaceuticals

Description: This bank describes information that is used in support of compliance monitoring and enforcement activities related to biologics and radiopharmaceuticals. Regulated products include blood and blood products, donor sperm and ova (eggs) and in vitro embryos for the purpose of assisted human reproduction, viral and bacterial vaccines, gene therapy products, cells, tissues, organs and xerographs, which are manufactured in Canada or elsewhere.

Activities related to assisted human reproduction materials (i.e., donor sperm and eggs and in vitro embryo) which are subject to compliance monitoring and enforcement include: reimbursing sperm and egg donors for expenditures incurred in the course of donating; reimbursing surrogate mothers for expenditures incurred by her in relation to her surrogacy; reimbursing surrogate mothers for loss of work-related income incurred during her pregnancy; reimbursing persons for expenditures related to the maintenance or transport of an in vitro embryo; providing consent for the use of donated human reproductive material for the purpose of creating an embryo.

Potential non-compliance may be identified by consumer complaints, industry complaints, referrals from other provincial and federal regulatory agencies, international partners or Health Canada's compliance monitoring activities. The personal information may include name, contact information, biographical information, educational information, other identification numbers and written details associated with complaints submitted by the public or industry (what, when, where, who and how something happened) purchasing orders, and sales receipts.

Class of Individuals:

General public, industry employees (manufacturers, primary establishments, importers and distributors), health care professionals and healthcare facility employees/professionals.

Purpose: The personal information is used to support Health Canada's compliance and enforcement activities, including inspections and investigations, related to biologics and radiopharmaceuticals. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act; Food and Drugs Regulations; Safety of Human Cells, Tissues and Organs for Transplantation Regulations;; pursuant to 47 (2) of the Assisted Human Reproduction Act; Safety of Sperm and Ova Regulations; Reimbursement Related to Assisted Human Reproduction Regulations; Administration and Enforcement (Assisted Human Reproduction Act) Regulations; Assisted Human Reproduction (Section 8 Consent) Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: audit and evaluation, compliance and enforcement, and safety purposes. Information may be disclosed to the Canada Border Services Agency (CBSA) [CBSA PPU 035] to target a specific individual who has been identified as having potential for non-compliance with the Food and Drugs Act, the Assisted Human Reproduction Act and its associated Regulations. Personal information collected, audited and evaluated during inspections and investigations may be shared with law enforcement agencies for law enforcement and criminal investigation purposes, with other branches or directorates of Health Canada for the administration of other acts under which biologic or radiopharmaceutical is regulated, with provincial (or territorial) health professional regulatory bodies when the health and safety of Canadians may be impacted due to non-compliance under a different regulatory jurisdiction, and/or with Health Canada's foreign regulatory counterparts which have similar mandates for the consistent regulation of health products on the international stage.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 035

TBS Registration: 20110562

Bank Number: HC PPU 408

Patient Safety

Health Canada's Strategic Policy Branch provides and synthesizes broad policy advice that helps to advance patient safety in health care systems. The contribution to the Canadian Patient Safety Institute (CPSI) supports the federal government's interest in achieving an accessible, high quality, sustainable and accountable health system adaptable to the needs of Canadians. CPSI's work is designed to improve the quality of health care systems by providing a leadership role in building a culture of patient safety and quality improvement through coordination across sectors, promotion of best practices, and advice on effective strategies to improve patient safety. Its emphasis is on: education, focused on developing curriculum and training programs; interventions and programs, focused on supporting evidence-informed clinical interventions and programs; research, to increase the scope and scale of patient safety research; and tools and resources, focused on creating tools and resources that can be applied by health care organizations. Target populations include: patients and their families, the medical community, provincial health quality councils, health care leaders, researchers, administrators, policy/decision-makers, educators, and governments. CPSI consults and collaborates with an extensive and diverse network of stakeholders that includes governments, patients, health care organizations and professionals, and international organizations.

Patient Safety

Description: Includes records related to policy advice that helps to advance patient safety in health care systems and contributions to the Canadian Patient Safety Institute.

Document Types: correspondence, memoranda, complaints, consultation, grants and contributions agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC PAS 005

Promoting Minority Official Languages in the Health Care Systems

This program is designed to support the federal obligation to take positive measures to enhance the vitality of the Official Language Minority Communities (OLMCs) in Canada and to support and assist their development and foster the full recognition and use of both English and French in Canada. It also includes the Official Languages Health Contribution Program, which fosters collaboration and innovation in the areas of recruitment, training, retention, networking, research, organization and support to the delivery of health services to French-speaking communities in provinces and territories other than Quebec and to English-speaking communities in the province of Quebec. The Program engages communities and health stakeholders to improve access to health care by increasing the supply of health professionals able to provide health services to OLMCs in their language of choice, and improving the provision of health services in both official languages.

Official Language Minority Community Development Program

Description: Includes records relating to improving health and health services for official language minority communities across Canada and promoting increased use of both official languages in the provision of these health services. Specific records will include research, planning and evaluation techniques.

Document Types: research proposals, analysis, and reports, performance frameworks, audit and evaluation reports, draft policies, correspondence, memoranda, public relations materials, presentations, contribution proposals, contracts and funding agreements with collaborators, information sharing agreements, research files of published and unpublished data, strategic policy advice, briefing notes, meeting agendas and minutes.

Record Number: HC OLM 015

Substance Use and Addictions

The objective of the Substance Use and Addictions Program is to support other levels of government, community-based and national non-profit organizations to respond to ongoing and emerging drug and substance use issues across Canada by: preventing problematic substance use and reducing harms; facilitating treatment and related system enhancements; and, improving awareness, knowledge, skills and competencies of targeted stakeholders and Canadians. To achieve this objective, the Program provides grants and contributions funding for a wide range of evidence-informed and innovative problematic substance use prevention, harm reduction and treatment initiatives across Canada at the community, regional and national levels. Initiatives target a range of psychoactive substances, including opioids, cannabis, alcohol and tobacco. The Program supports Health Canada's core responsibility of Health Care Systems, contributing to Canadians making healthier choices and having better health outcomes. The Program is a partner in the Canadian Drugs and Substances Strategy and Canada's Tobacco Strategy, and supports the objectives of Health Canada's Tobacco Control, Controlled Substances and Cannabis Programs. The Program provides core funding to the Canadian Centre on Substance Use and Addiction, a pan-Canadian health organization with a legislated mandate under the Canadian Centre on Substance Abuse (CCSA) Act.

Substance Use and Addictions

Description: Includes records related to grants and contributions funding to other levels of government, community-led and not-for-profit organizations, as well as individuals (micro-grant funding only), to respond to drug and substance use issues in Canada.

Document Types: correspondence, memoranda, complaints, consultation, grants and contributions agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC SU 005

Territorial Health Investment Fund

The objective of the Territorial Health Investment Fund is to improve Northerners' access to health services to meet their health care needs and to improve their health status. Through targeted transfers to territorial governments, the program supports projects that use and promote the uptake of innovative health human resources approaches and technologies. The Program also offsets eligible medical transportation costs incurred by each territorial government, as defined by their respective medical transportation policies. In so doing, the program also contributes to patient satisfaction and quality of services available in small, geographically isolated communities.

Territorial Health Investment Fund

Description: Includes records related to improving Northerners' access to health services, including transfers to territorial governments, projects that use and promote the uptake of innovative health human resources approaches and technologies and eligible medical transportation costs incurred by each territorial government.

Document Types: correspondence, memoranda, complaints, consultation, transfer agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC THIF 005

Thalidomide

One of the key priorities for the federal government is to provide Canadians with affordable, sustainable and efficient health care systems that take into account their specific needs. The Canadian Thalidomide Survivors Support Program (CTSSP), which replaced the Thalidomide Survivors Contribution Support Program (TSCP), is intended to contribute to meeting the lifetime needs of Canadian thalidomide survivors so that they may age with dignity. Thalidomide was a drug marketed and approved in Canada in the early 1960's as a sedative but was also effective in treating morning sickness in pregnant women. Tragically, when taken in the first trimester of pregnancy, the drug had devastating consequences which led to miscarriages, birth defects and even death. The CTSSP uses a probability-based medical assessment process to confirm eligibility under the program. It provides ongoing assistance to Canadian thalidomide survivors based on their level of disability, as well as access to an Extraordinary Medical Assistance Fund (EMAF) to pay for home and vehicle adaptations or specialized surgery not covered by other provincial/territorial health plans.

Thalidomide

Description: Includes records related to the needs of Canadian Thalidomide survivors and to the Canadian Thalidomide Survivors Support Program.

Document Types: correspondence, memoranda, complaints, consultation, grants and contributions agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC THA 005

Health Protection and Promotion

Health Canada works with domestic and international partners to assess, manage and communicate the health and safety risks and benefits associated with health and consumer products, food, chemicals, pesticides, environmental factors, tobacco and controlled substances.

Air Quality

The Air Quality program supports actions to improve air quality and health for all Canadians. Key activities include research on exposure of Canadians to air pollution and on the health impacts of air pollution; assessments of the health risks from air pollutants and pollutant sources; and quantification of the health benefits from actions to improve air quality. This information is made available to stakeholders including governments, industry, health professionals and directly to the public. It also plays an important role in guiding actions under the Air Quality Management System, a collaborative effort among the federal government, provinces and territories and other key stakeholders to improve air quality in Canada, led by Environment and Climate Change Canada, but for which health is a key driver. The Air Quality Management System includes Canadian Ambient Air Quality Standards meant to drive continuous improvement in air quality. The Air Quality program also works with Environment and Climate Change Canada to implement the Air Quality Health Index, a tool designed to help Canadians make decisions to protect their health by adjusting their activity levels during increased levels of air pollution. Finally, the program also develops guidance to better manage indoor air quality for public health professionals and Canadians. These activities support Health Canada's Core Responsibility of Health Protection and Promotion.

Safe Environments / Environmental and Radiation Health Sciences - Air Quality

Description: Includes records related to research regarding the health impacts of indoor and outdoor air quality. Research supports the development of indoor air quality guidelines and mitigation strategies to protect human health, assessments of contaminants, development of outdoor air quality standards, and outreach initiatives such as the Air Quality Health Index.

Document Types: public opinion research, health hazard assessments and evaluations, surveillance and monitoring documentation, research proposals, analysis, and reports, exposure monitoring results, lab test results, correspondence, presentations, questionnaires, briefing notes, contracts with collaborators, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, fact sheets, committee agendas, reports and minutes, guidelines and standards, educational and outreach bulletins and other documentation.

Record Number: HC ERH 015

Child Acute Respiratory Effects Study

Description: This bank contains information on the respiratory illnesses and pulmonary function measures and the ages of 100 females aged 7 to 15 years attending a Girl Guide camp (Camp Kiawa) in July and August of 1986. Data on parental smoking habits, education and other home characteristics were collected. Allergy test and heart rate monitoring results are also recorded.

Class of Individuals: Girls aged 7 to 15 years who attended Camp Kiawa from July 1 to August 10, 1986.

Purpose: The purpose of this bank is to examine the relationship between transported air pollution and respiratory health in children.

Consistent Uses: There will be no disclosure of any personal information from this data bank. Only summary statistics and conclusions drawn from the study will be publicly disclosed. There will be no linking and matching of information in this data bank with any other information or data bank presently existing.

Retention and Disposal Standards: Under Review at LAC - ten years.

RDA Number: 2015/022

Related Record Number: HC ERH 015

TBS Registration: 004096

Bank Number: HC PPU 036


Children's Respiratory Health Study

Description: This bank contains information about children and adolescents currently residing in Saint John, New Brunswick. The data consists of questionnaires completed by parents for grade five students and self-completed by grade twelve students. In addition, students will have height, weight and their lung capacity measured. The information collected includes name, address, telephone number of the students and parent or legal guardian and the gender of the child/adolescent.

Class of Individuals: Grade five children, ages nine to eleven and grade twelve students, ages sixteen to eighteen, residing in Saint John, New Brunswick.

Purpose: To assess the longer term effects of exposure to air pollution in children and adolescents.

Consistent Uses: Information may be used to contact these individuals in follow-up survey.

Retention and Disposal Standards: Under Review at LAC - ten years.

RDA Number: 2015/022

Related Record Number: HC ERH 015

TBS Registration: 004097

Bank Number: HC PPU 089


Research into the Health Effects of Air Pollution

Description: This bank describes information that is used in support of research into the health effects of air pollution, under the Clean Air Regulatory Agenda. The personal information may include name, contact information, date of birth, medical information, physical attributes, signature and biological samples, clinical tests, home air samples and consent forms.

Note: In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request form, individuals requesting information described by this bank must provide the name, location, and year of the study.

Class of Individuals: General public.

Purpose: The personal information is used to perform research into the health effects of air pollution. Personal information is collected pursuant to Canadian Environmental Protection Act (1999) and the Department of Health Act.

Consistent Uses: The information may be used or disclosed for the following purposes: aggregated data is published in final study reports and peer review journals.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC ERH 015

TBS Registration: 20110504

Bank Number: HC PPU 314

Biologics and Radiopharmaceutical Drugs

The program is responsible for ensuring biologic and radiopharmaceutical drugs in Canada are safe, effective and of high quality. It verifies that regulatory requirements for the safety, quality, and efficacy of biologic and radiopharmaceutical drugs sold in Canada are met through pre-market submissions review, risk-benefit assessments, monitoring, surveillance, compliance, and enforcement activities. The program provides information to Canadians and health professionals to enable them to make informed decisions about product use. The program aligns with the Departmental Results Framework "Health Protection and Promotion" Core Responsibility and supports the result "Canadians have access to safe, effective and quality health products." Target populations include industry, (including market authorization holders and registered establishments licence holders), health professionals and practitioners, and Canadians. Key stakeholder roles are to comply with responsibilities under the Food and Drugs Act and Regulations (industry); to promote the appropriate use of biologic and radiopharmaceutical drugs (health professionals and practitioners); and to report adverse reactions also known as side effects to Health Canada (industry; health care professionals/practitioners; and Canadians).

Biologics and Genetic Therapies

Description: Includes records relating to the development of new policies, guidance documents or regulations, and the updating of existing policies related to biologics, radiopharmaceuticals, genetic therapies, and of tissues, cells, and organs for transplantation. Includes records related to the process of regulating biologics and genetic therapies including pre-market submissions, and clinical trials. Records may include third party or internal research. Records also include documentation in support of two centers: the Centre for Biologics Evaluation (CBE) and the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB).

Document Types: Adverse reaction reports for clinical trials, health hazard assessments and evaluations, research proposals, analysis, and reports (including pre-clinical and clinical studies), correspondence, memoranda, public relations materials, presentations, contracts with collaborators, information sharing agreements, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, standards, product evaluations, drug approval submissions from manufacturers, briefing notes, committee meeting agendas, terms of reference and minutes, notices of compliance, standard operating procedures, strategic planning documents, and summary basis of decision educational and outreach documentation.

Record Number: HC HP 025


Canada Vigilance Adverse Reaction Program

Description: This bank describes information collected by Health Canada regarding adverse reactions to drugs, natural health products, diagnostic or therapeutic health products, biologics, cells, tissues and organs. The personal information collected may include the name and contact information and signature of the individual reporting the reaction and information regarding the individual who experienced the reaction including their initials, physical attributes, date and place of birth and death, medical information, biographical information, identifying file number, adverse reaction history details and the facility where the individual has received treatment.

Class of Individuals: General public, industry employees (manufacturers, importers, distributors), and health care facility employees/professionals who report adverse reactions and the individuals who experienced the adverse reaction.

Purpose: To assess adverse reaction reports; monitor safety; and enforce relevant legislation(s) where applicable. Information is collected pursuant to the Department of Health Act, section 4; Food and Drug Regulations, Section(s) C.01.017, C.05.014, C.08.010 (b), C.08.008 (c); (i) Safety of Human Cells, Tissues and Organs for Transplantation Regulations; Section 51 (1) Blood Regulations; Sections 109-116, the Natural Health Products Regulations; Part 1 and Safety of Sperm and Ova Regulations; sections 69 to 76.

Consistent Uses: Vaccine adverse reaction reports may be disclosed to the provincial or territorial bodies responsible for public health for follow up. Personal information may be used to analyze general trends, report to senior management, as well as audit related programs and services. Trend and safety data in a de-identified format may be communicated by a variety of risk communication tools and / or responses to inquiries. A subset of de-identified Canada Vigilance data is made publicly available from the Canada Vigilance Adverse Reaction Online Database. Personal information may be shared with the Public Health Agency of Canada, Canadian Medication Incident Reporting and Prevention (managed in partnership with the Canadian Institute for Health Information), the Institute for Safe Medication Practices, the Canadian Safety Institute, and international regulatory and health product monitoring authorities, for monitoring adverse reactions.. In limited and specific circumstances, personal information may be disclosed to law enforcement where disclosure is necessary for the purpose of eliminating or reducing a significant risk of serious bodily harm to a person or group of persons.

Retention and Disposal Standards: Retained for seventy five years after receipt of adverse reaction report.

RDA Number: 2015/022

Related Record Number: HC HP 005; HC HP 025

TBS Registration: 20180018

Bank Number: HC PPU 417

Marketed Health Products - Biologics and Radiopharmaceuticals

Description: Includes records related to the post-market safety of federally regulated and marketed biologics and genetic therapies health products. Records include information about the Canada Vigilance Program (which collects, processes and monitors adverse reactions), the MedEffect™ Canada Web site, the Canadian Medication Incident Reporting and Prevention program (managed in partnership with the Canadian Institute for Health Information, the Institute for Safe Medication Practices and the Canadian Patient Safety Institute), and documentation supporting the Expert Advisory Committee on the Vigilance of Health Products.

Document Types: public opinion research, surveillance and monitoring documentation, analysis reports (including clinical studies), correspondence, memoranda, public relations materials, presentations, briefing notes, contracts with collaborators, information sharing agreements, research proposals, analysis and reports, adverse reaction reports, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risks assessments, standards, product evaluations, submissions from manufacturers, terms of reference, committee agenda items, minutes and reports, product monographs, product advisories, warnings, and recalls, educational and outreach materials.

Record Number: HC HP 030

Compliance and Enforcement Activities related to - Biologics and Radiopharmaceuticals

Description: Includes records related to compliance and enforcement activities for biologics and radiopharmaceutical therapies. Records include documentation used for compliance monitoring, and compliance verification and investigation, including establishment licensing and registering of biologics and radiopharmaceuticals drugs and laboratory analysis.

Document Types: Inspection and investigation documentation and reports, correspondence, memoranda, public relations materials, presentations, contracts with collaborators, information sharing agreements, strategic policy advice, licences, registrations, compliance reports, report of examination for customs entries, briefing notes, risk assessments, standards, product evaluations, monitoring logs, laboratory data, purchasing orders, sales receipts and declarations

Record Number: HC HP 035

Border Program

Description: This bank describes information that is related to the Border Program. The Border Program conducts compliance and enforcement activities for imported health products (e.g., drugs, natural health products and medical devices) to ensure that they meet the requirements of admissibility under the Food and Drugs Act and its associated Regulations before they are allowed into Canada. The personal information may include name, contact information, customs identifier, license information, medical information (if related to the importer/exporter), and product information (where it reveals personal information about the importer / exporter).

Note: Information may be stored in the following internal systems / databases: Border Compliance and Operations Database.

Class of Individuals: Individuals who attempt to import or export health products

Purpose: The personal information is used by the Border Program to assess the admissibility of the health product for import / export. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act.

Consistent Uses: Personal information may be used for program evaluation, statistical, compliance and enforcement purposes [HC PPU 402; HC PPU 405; HC PPU 406; HC PPU 407; HC PPU 408] and shared with the Special Access Program [HC PPU 414; HC PPU 430] and the Canada Border Services Agency.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 005, HC HP 020, HC HP 035, HC HP 045, HC HP 050, HC HP 065

TBS Registration: 20210026

Bank Number: HC PPU 436


Compliance and Enforcement - Biologics & Radiopharmaceuticals

Description: This bank describes information that is used in support of compliance monitoring and enforcement activities related to biologics and radiopharmaceuticals. Regulated products include blood and blood products, donor sperm and ova (eggs) and in vitro embryos for the purpose of assisted human reproduction, viral and bacterial vaccines, gene therapy products, cells, tissues, organs and xerographs, which are manufactured in Canada or elsewhere.

Activities related to assisted human reproduction materials (i.e., donor sperm and eggs and in vitro embryo) which are subject to compliance monitoring and enforcement include: reimbursing sperm and egg donors for expenditures incurred in the course of donating; reimbursing surrogate mothers for expenditures incurred by her in relation to her surrogacy; reimbursing surrogate mothers for loss of work-related income incurred during her pregnancy; reimbursing persons for expenditures related to the maintenance or transport of an in vitro embryo; providing consent for the use of donated human reproductive material for the purpose of creating an embryo.

Potential non-compliance may be identified by consumer complaints, industry complaints, referrals from other provincial and federal regulatory agencies, international partners or Health Canada's compliance monitoring activities. The personal information may include name, contact information, biographical information, educational information, other identification numbers and written details associated with complaints submitted by the public or industry (what, when, where, who and how something happened) purchasing orders, and sales receipts.

Class of Individuals: General public, industry employees (manufacturers, primary establishments, importers and distributors), health care professionals and healthcare facility employees/professionals.

Purpose: The personal information is used to support Health Canada's compliance and enforcement activities, including inspections and investigations, related to biologics and radiopharmaceuticals. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act; Food and Drugs Regulations; Safety of Human Cells, Tissues and Organs for Transplantation Regulations;; pursuant to 47 (2) of the Assisted Human Reproduction Act; Safety of Sperm and Ova Regulations; Reimbursement Related to Assisted Human Reproduction Regulations; Administration and Enforcement (Assisted Human Reproduction Act) Regulations; Assisted Human Reproduction (Section 8 Consent) Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: audit and evaluation, compliance and enforcement, and safety purposes. Information may be disclosed to the Canada Border Services Agency (CBSA) [CBSA PPU 035] to target a specific individual who has been identified as having potential for non-compliance with the Food and Drugs Act, the Assisted Human Reproduction Act and its associated Regulations. Personal information collected, audited and evaluated during inspections and investigations may be shared with law enforcement agencies for law enforcement and criminal investigation purposes, with other branches or directorates of Health Canada for the administration of other acts under which biologic or radiopharmaceutical is regulated, with provincial (or territorial) health professional regulatory bodies when the health and safety of Canadians may be impacted due to non-compliance under a different regulatory jurisdiction, and/or with Health Canada's foreign regulatory counterparts which have similar mandates for the consistent regulation of health products on the international stage.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 035

TBS Registration: 20110562

Bank Number: HC PPU 408

Food and Drugs Act Liaison

Description: Includes records related to complaints, concerns or enquiries pertaining to the Food and Drugs Act. These records assist the department to communicate with stakeholders, facilitate resolutions, and prepare reports.

Document Types: correspondence, memoranda of understanding, reports, presentations, questionnaires, briefing notes, consultation and outreach documentation.

Record Number: HC DSS 010

Food and Drugs Act Liaison Office

Description: This bank describes information that is used in support of the activities of Food and Drugs Act Liaison Office and requests under the reconsideration process for decisions about human drugs and natural health products. Activities may include interactions with external stakeholders and Health Canada staff regarding regulatory process, as well as receiving and responding to complaints, concerns or enquiries about alleged acts, omissions, improprieties and broader systemic problems on matters pertaining to the Food and Drugs Act. The personal information may include name, contact information, biographical information, medical information, physical attributes, signature, complaint, and official language of preference.

Note: Information may be stored in the following internal systems / databases: Food and Drug Act Liaison Office Case Tracking System.

Class of Individuals: General public, government employees, business contacts, and academia.

Purpose: The personal information is used to communicate with stakeholders, to respond to complaints and enquiries by facilitating the resolution of issues concerning the Food and Drugs Act. Personal information is collected pursuant to the Food and Drugs Act.

Consistent Uses: The information may be used or disclosed for the following purposes: reporting to senior management, audit and evaluation and annual reporting (in aggregate format). With consent, personal information may be disclosed to Health Canada staff, for resolving complaints. With consent, personal information may be shared with Canada Food Inspection Agency employees to resolve complaints.

Retention and Disposal Standards: Retained for seven years after case closed.

RDA Number: 2015/022

Related Class of Record Number: HC DSS 010

TBS Registration: 20110561

Bank Number: HC PPU 411

Cannabis

The Cannabis Program supports the Government in the administration of the Cannabis Act, which strictly regulates activities with cannabis, including its production, sale, import/export and possession. The Cannabis Program is dedicated to policy and regulatory development; licensing cannabis and hemp producers; registering individuals who are authorized to produce a limited amount of cannabis for their own medical purposes; engaging with key partners (e.g., provinces, territories, Indigenous organizations); compliance and enforcement; public education and communications; and research, monitoring and surveillance.

Cannabis

Description: Includes records related to the administration and enforcement of the Cannabis Act.

Document Types: correspondence, memoranda, complaints, consultation, grants and contributions agreements, outreach and public relations materials, reports, briefing notes, policies, presentations, provincial/territorial call and meeting material, and annual report to Parliament.

Record Number: HC CAN 005

Authorizations for marihuana for medical purposes

Description: This bank describes information that is related to applications for authorization to possess and / or produce marihuana and to purchase dried marihuana and / or marihuana seeds, for medical purposes under the Marihuana Medical Access Program. The personal information may include name, contact information, biometric information, credit information, criminal checks/history, date of birth, date of death, medical information, other identification numbers, physical attributes, signature and physician's support of the application, consent of the property owner for marihuana production, consent of the applicant to disclose to an authorized individual, photograph of the applicant and power of attorney.

Note: The Marihuana Medical Access Regulations were repealed on March 31, 2014. New applications are no longer being accepted under these regulations.

Class of Individuals: Applicants to the Marihuana Medical Access Program, physicians who support medical marihuana access applicants, property owners who allow marihuana production, individuals given permission to act on behalf of applicants, complainants.

Purpose: The personal information is used to determine eligibility to produce and/ or possess marihuana, to provide dry marihuana or seeds, and to process payments for purchase of marihuana and seeds. Personal information is collected pursuant to section 56 of the Controlled Drugs and Substances Act and under the Marihuana Medical Access Regulations (MMAR).

Consistent Uses: The information may be used or disclosed for the following purposes: may use applicant information to contact a supporting physician in order to verify medical information on the application form, and contact information for consultations on new regulations; may disclose contact and order information to a contracted product supplier, contact and overdue accounts receivable information to a collection agency, may use personal information collected under MMAR to inform the Marihuana for Medical Purposes Regulations (MMPR) security clearance process for those individuals who have applied for licenses under the MMPR. Health Canada discloses, audits and evaluates personal information and the terms and conditions of the authorization to law enforcement agencies.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC CAN 005

TBS Registration: 005331

Bank Number: HC PPU 073

Climate Change

The purpose of the Climate Change program is to support Health Canada's core responsibility of Health Protection and Promotion by continuing to increase the knowledge, capacity, and tools on climate change and health risks available to healthcare and public health professionals, emergency preparedness officials and provincial and local decision-makers across Canada, as well as by increasing the level of awareness among Canadians of extreme heat health risks. Information on climate change, health risks and health protection advice is also provided to the general public. This work is conducted in partnership with provinces and territories, communities, academic institutions, international organizations, and health ministries in other countries.

Safe Environments - Climate Change

Description: Includes records related to research regarding the scope and magnitude of the current and potential health impacts of climate change in Canada related to extreme heat events and other natural hazards as well as Canada's capacity to respond.

Document Types: public opinion research, surveillance and monitoring documentation, research proposals, analysis, and reports, questionnaires, correspondence, presentations, contracts with collaborators and service providers, research files of published and unpublished data, strategic policy advice, draft legislation, risk assessments, fact sheets, briefing notes, research funding agreements, committee agendas, reports and minutes, educational and outreach bulletins and other documentation.

Record Number: HC ERH 005

Consumer Product Safety

The Consumer Product Safety Program's objective is to manage the potential health and safety risks posed by consumer products and cosmetics in the Canadian marketplace. This objective supports the department's Core Responsibility of Health Protection and Promotion by reducing adverse health occurrences related to products available to Canadians. The Program identifies, assesses, manages and communicates health or safety risks associated with consumer products and cosmetics to Canadians. Efforts are focused in three areas: active prevention (such as the development and promotion of standards, and increasing consumer awareness); targeted oversight (such as sampling consumer products to confirm compliance with health and safety requirements); and rapid response (which includes the effective use of compliance and enforcement tools such as recalls). The Canada Consumer Product Safety Act and the cosmetics provisions of the Food and Drugs Act provide the authorities for this program to support industry's responsibility for the safety of their products and consumers' responsibility to make informed decisions about product purchase and use.

Consumer and Public Involvement

Description: Includes records related to outreach activities, communications with program clients, stakeholders and the public on issues relating to health products, food safety, and nutrition.

Note: The personal information has been destroyed in accordance with the disposal standard. The PIB reference will be removed from the Index in the 2019 publication.

Document Types: correspondence and invitations for consultations.

Record Number: HC DSS 015

Patient and Consumer Participation

Description: This bank describes information that is used in support of establishing a pool of individuals whose input will be solicited by departmental programs on a range of health product, food and drug related consultations and outreach activities. The personal information includes name, contact information, gender, ethnic origins, household income, biographical information, educational information, interests in food safety, nutrition, health products, drugs and health conditions, professional or volunteer experience related to health products and/or food, and funding affiliation.

Note: The personal information reflected here has been destroyed, in accordance with the disposition standard. The PIB reference will be removed from the index in the 2019 publication.
Pending TBS approval.

Class of Individuals: General public, applicants to the Patient and Consumer pool.

Purpose: The personal information is used to determine eligibility for a Patient and Consumer pool. Application information will be used to match pool members to specific program criteria for specific consultations and or outreach activities. Contact information will be used to determine availability and schedule participation of pool members. Personal information is collected pursuant to the Department of Health Act, the Food and Drugs Act, and the Food and Drugs Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: applicant contact information and interests will be disclosed to programs conducting specific consultations and or outreach activities, aggregate information will be used for reporting to senior management and evaluation.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC DSS 015

TBS Registration: 20110565

Bank Number: HC PPU 413

Requests for Confidential Business Information

Description: Includes records related to requests for the disclosure of confidential business information relating to therapeutic products and supporting information to verify the requester is a person who carries out functions relating to the protection or promotion of human health or the safety of the public as required by section 21.1(3)(c) of the Food and Drugs Act.

Document Types: Request forms, confidentiality agreements, conflict of interest declaration forms, correspondence, communications materials, briefing notes, agendas, minutes, presentations, procedures, curriculum vitae, proof of education documents, working notes, legal opinions, assessments, recommendation documents.

Record Number: HC HP 070

Requests for Disclosure of Confidential Business Information

Description: This bank describes information that is used in support of the processing and assessment of requests for confidential business information under the Food and Drugs Act. The personal information may include the requester's name, contact information, work history, educational information, signature, preferred language, conflict of interest declaration including funding affiliations and financial interests.

Note: Information may be stored in the following internal systems / databases: Records, Document and Information Management System (RDIMS).

Class of Individuals: General public

Purpose: The personal information is used to determine whether to grant or deny access to the requested confidential business information and whether the requester fulfills the criteria under the Food and Drugs Act that they carry out functions relating to the protection or promotion of human health or the safety of the public. Personal information is collected pursuant to paragraph 21.1(3)(c) of the Food and Drugs Act.

Consistent Uses: The information may be used or disclosed for the following purposes: the name of the requester, their affiliations, confirmation that a confidentiality agreement was signed, and the subject of the requested information to the originator of the confidential business information and/or the public. De-identified reports may be submitted to senior management to report on the number of requests that have been received and responded to.

PIA: A PIA has been developed and submitted to the Treasury Board Secretariat on August 23rd, 2016.

Retention and Disposal Standards: Retained for two years after last administration action.

RDA Number: 2015/022

Related Class of Record Number: HC HP 070

TBS Registration: 20200010

Bank Number: HC PPU 416

Consumer Products Safety Assessment Activities

Description: Includes records related to the assessment of safety risks associated with consumer products including cosmetics.

Document Types: public opinion research, surveillance and monitoring documentation (includes research proposals, data analysis, and reports), correspondence, briefing notes, complaints, incident reports, presentations, contracts, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, laboratory reports, committee documentation (including agendas, reports and minutes), consumer product advisories, warnings and recall notices, input related to product standards, educational and outreach documentation (including interpretive guidance).

Record Number: HC CPS 005

Branch Incident Reporting

Description: This bank contains information about complaints, incidents or queries received in regard to actual or perceived problems or concerns with consumer products, cosmetics and other items that are regulated by Health Canada. Information may include name, address, telephone number of the contact person, product description such as make, model, serial or other identifying number, location of incident, any follow-up action taken and other details required for any necessary intervention by Health Canada or other authorities.

Class of Individuals: Canadians or visitors to Canada, medical practitioners and hospital authorities, police and customs agents, coroners and provincial medical officers of health and representatives of manufacturers or trade who may be involved with the reporting or investigation of a complaint or incident.

Purpose: To investigate and track complaints and incident reports received by the Department.

Consistent Uses: Information may be used to follow-up with complainants. It may be shared with other agencies including Canadian Food Inspection Agency, provincial regulatory authorities, provincial Medical Officers of Health and individual practitioners.

Retention and Disposal Standards: Under Review at LAC – twenty five years, transferred to LAC after retention period completed.

RDA Number: 2015/022

Related Record Number: HC CPS 005

TBS Registration: 004102

Bank Number: HC PPU 088


Compliance and Enforcement - Pest Control Products

Description: This bank describes information that is used in support of compliance and enforcement activities related to pest control products as defined under the Pest Control Products Act and its regulations. Potential non-compliance may be identified by consumer complaints, industry complaints, referrals from other provincial and federal regulatory agencies, international partners or Health Canada's other compliance and enforcement activities. The personal information may include name, contact information, biographical information, written details associated with complaints submitted to Health Canada (what, when, where, who and how something happened), and records of import, manufacture, distribution, storage, possession, and use.

Class of Individuals: General public, particularly those impacted by activities related to pest control products and regulated parties under the Pest Control Products Act and its regulations.

Purpose: The personal information is used to support Health Canada's compliance and enforcement activities, including compliance promotion, inspections and investigations, related to pest control products. Personal information is collected pursuant to section 48(1) of the Pest Control Products Act and its regulations.

Consistent Uses: Personal information may be disclosed to the Canada Border Services Agency (CBSA) [CBSA PPU 035] to target a specific individual who has been identified as having potential for non-compliance with the Pest Control Products Act and its regulations. Personal information collected during inspections and investigations may be shared with law enforcement agencies for law enforcement and criminal investigation purposes, with other branches or directorates of Health Canada [HC PPU 088, HC PPU 406, HC 415 and HC PPU 045] for the administration of other acts under which the pest control products are regulated, with provincial (or territorial) pest control product regulatory bodies when the health and safety of Canadians may be impacted due to a non-compliance under a different regulatory jurisdiction, and/or with Health Canada's foreign regulatory counterparts which have similar mandates for the consistent regulation of pest control products on the international stage. Personal information may also be used for reporting to senior management or program evaluation.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC CPS 005

TBS Registration: 20180031

Bank Number: HC PPU 402

Controlled Substances

The Controlled Substances Program authorizes legitimate activities with controlled substances and precursor chemicals, while managing the risks of diversion and associated harms that could affect public health and safety. To achieve this objective, the Program regulates manufacturing, medical, and scientific industries on the possession, production, provision and disposition of controlled substances and precursor chemicals. Key activities: reviewing and updating the regulatory framework for controlled substances and precursor chemicals as required; administering regulations for licensing and compliance monitoring activities; analyzing seized materials; providing training and scientific knowledge on illegal drugs and precursor chemicals; assistance in investigating and dismantling clandestine laboratories; surveillance activities to address drug and substance use in Canada; and, working with national and international partners for the recommendation of appropriate drug analysis procedures. The Program supports Health Canada's core responsibility of Health Protection and Promotion and helps ensure that Canadians make healthier choices. The Program leads the Canadian Drugs and Substances Strategy, the Government of Canada's comprehensive, collaborative, compassionate and evidence-based approach to problematic drug and substance use. The Program administers the Controlled Drugs and Substances Act and its regulations, and Parts G and J of the Food and Drug Regulations.

Administration of the Controlled Drugs and Substances Act

Description: Includes records related to the administration of the Controlled Drugs and Substances Act and its regulations. Records may include guidance documents, issue analysis summaries, risk assessments, research and surveillance reports and other documents used to develop substance abuse related policies in Canada; planning and evaluation documentation in support of community interventions, media and public awareness campaigns; records related to the National Anti-Drug Strategy, Drug Treatment Funding Program and Drug Strategy Community Initiatives Fund, and the Anti-Drug Strategy Initiatives Fund.

Document Types: public opinion research, surveillance and monitoring documentation, application forms and supporting documentation, research proposals, analysis, and reports, correspondence, presentations, contracts with collaborators, authorizations to prescribe, dispense, or possess controlled substances, research files of published and unpublished data, strategic policy advice, briefing notes, draft legislation and regulatory frameworks, risk assessments, licenses, fact sheets, committee agendas, reports and minutes, sales records, advisories, educational and outreach documentation.

Record Number: HC SUA 010

Production of Cannabis for Own Medical Purposes Registration Program

Description: This bank describes information that is related to individuals who apply to register for the personal production of cannabis for medical purposes in accordance with the Cannabis Regulations. The personal information may include name, contact information, criminal record check/history, date of birth, registration number, other identification numbers (e.g., law enforcement badge number, medical professional licensing number), authorized amount of cannabis for medical purposes, production and storage site of cannabis, preferred official language, signature, registration effective and expiration date, and enquires.

Note: Information may be stored in the following internal system / databases: Medical Cannabis Registry, and the Rogers Virtual Call Centre, where recorded phone call conversations are retained.

Class of Individuals: General public, applicants, individuals who are designated by or responsible for the applicant, medical professionals, home owners who allow production and/or storage of cannabis, and law enforcement officers.

Purpose: The personal information is used to process applications to register for the personal production of cannabis for medical purposes and to respond to enquiries. Personal information is collected pursuant to section 312 of the Cannabis Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: enforcement of the Cannabis Act and Cannabis Regulations; program evaluation; and aggregate information may be disclosed to provinces and territories and municipalities. Personal information may be disclosed to licensed producers to verify suspected fraudulent Registration Certificates. Specific personal information may be disclosed to law enforcement and professional licensing authorities as permitted under the Cannabis Regulations. Personal information may be disclosed to medical professionals to ensure the medical document submitted with the application was issued by them and to confirm the authorized amount. Personal information may be used for program evaluation, reporting to senior management, and for audit and evaluation purposes.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC SUA 010

TBS Registration: 20170120

Bank Number: HC PPU 074


Methadone Program

Description: This bank contains the names and addresses of practitioners authorized to purchase, prescribe or dispense methadone.

Note: The methadone regulatory process changed in 2018. New applications are no longer being accepted.

Class of Individuals: Practitioners.

Purpose: To keep records for practitioners authorized to purchase, prescribe or dispense methadone.

Consistent Uses: Information from this bank may be released to provincial licensing authorities of the health professions.

Retention and Disposal Standards: Practitioner files are kept two years after the death of a doctor, five years after the last correspondence or last record of registration if there is no history of drug-related problems, and ten years after the last correspondence or last record of registration if there is a history of drug-related problems.

RDA Number: 2015/022

Related Record Number: HC SUA 010

TBS Registration: 002730

Bank Number: HC PPU 060


Sales Records of Licensed Dealers

Description: This bank contains sales records of narcotics and controlled drugs made by licensed dealers who are entitled to import, export, manufacture and distribute narcotic and controlled drugs under the Controlled Drugs and Substances Act and Regulations.

Class of Individuals: Pharmacists, physicians, dentists, veterinarians, hospitals and licensed pharmaceutical companies.

Purpose: This bank is used to ensure that licensed narcotic and controlled drugs dealers supply narcotic and controlled drugs only to authorized persons.

Consistent Uses: It is also used to monitor and assess purchases of narcotics and controlled drugs made by pharmacists, physicians, dentists, veterinarians, hospitals and licensed pharmaceutical companies. Information from this bank may be released to provincial licensing authorities of the health professions.

Retention and Disposal Standards: Records on individual cases are held for three years for licensed dealers' sales reports and then reviewed for possible transfer to Library and Archives Canada.

RDA Number: 2015/022

Related Record Number: HC SUA 010

TBS Registration: 004107

Bank Number: HC PPU 045


Record of Researchers

Description: This bank provides a list of persons authorized to use, and who are using narcotic, controlled and restricted drugs in research work.

Class of Individuals: It is primarily concerned with scientists and medical and paramedical professionals.

Purpose: The bank is used to ensure that persons using narcotic, controlled and restricted drugs for research purposes have been authorized to do so.

Consistent Uses: None

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC SUA 010

TBS Registration: 002726

Bank Number: HC PPU 040


Loss or Theft of Controlled Substances and Precursors

Description: This bank describes information that relates to individuals who report the loss and theft of controlled substances and chemical precursors to Health Canada. The personal information includes their name, contact information, address where the loss or theft occurred, type of location (e.g., pharmacy, hospital), details of loss or theft, and other identification numbers (e.g., law enforcement badge number, medical professional licensing number).

Class of Individuals: Individuals involved in reporting loss and theft of controlled substances and precursor chemicals to Health Canada, law enforcement officers, and medical practitioners.

Purpose: The personal information is collected to record the loss or theft of controlled substances or chemical precursors. Personal information is collected pursuant to section 56 of the Controlled Drugs and Substances Act and relevant sections of the Narcotic Control Regulations, Parts G and J of the Food and Drugs Regulations, the Benzodiazepines and Other Targeted Substances Regulations, and the Precursor Control Regulations.

Consistent Uses: The personal information may be used to enforce the Controlled Drugs and Substances Act and its regulations. Personal information related to loss or theft of controlled substances and chemical precursors may be disclosed to provincial regulatory authorities (e.g. provincial colleges of pharmacy) and law enforcement. Personal information may be used for program evaluation, audit and/or statistical purposes.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC SUA 010

TBS Registration: 20210004

Bank Number: HC PPU 434

Food & Nutrition

The program is responsible for establishing regulations, guidelines, standards and policies pertaining to food safety, nutrition and healthy eating. The program conducts risk assessments pertaining to the chemical, microbiological and nutritional safety of foods, develops, promotes and implements evidence-based nutrition policies, advice, guidance and provides information to support healthy choices. This program aligns with the Departmental Results Framework "Health Protection and Promotion" Core Responsibility, and supports the result "Canadians make healthy choices." Target populations include: industries and food associations; regulatory partners, health professionals, non-government organizations, academics and Canadians. The Program works with various stakeholders such as Federal/Provincial and Territorial governments; and international regulators to improve the safety of the Canadian food supply; support a coordinated approach to nutrition issues; influence broader national and international strategies and initiatives that affect the food environment; and enable Canadians to make informed decisions about food and nutrition.

Food Safety Governance

Description: Includes records related to the standards, policies and regulations regarding food safety and nutritional risks. Records include risk assessments pertaining to chemical and microbiological safety and nutritional quality of foods as well as the pre-market submission process for the evaluation of food additives, infant formula, novel foods and supplemental foods, and health claims. Records include assessments of the effectiveness of the Canadian Food Inspection Agency's activities related to food safety.

Document Types: public opinion research, compliance monitoring and enforcement documentation and reports, inspection notes health hazard assessments and evaluations, applications and submissions for food additive novel food, infant formula, supplemental food, health claim approvals, research proposals, analysis, and reports, correspondence, presentations, contracts with collaborators, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, submissions from manufacturers, fact sheets, briefing notes, committee reports and minutes, product advisories, warnings and recalls, educational and outreach documentation, guidance documents, international standards and guidelines, stakeholder and public inquiries and responses.

Record Number: HC FSN 005

Nutrition and Healthy Eating

Description: Includes records related to the development and promotion of policies, standards and guidelines regarding nutrition and healthy eating. Includes records relating to collaboration with stakeholders on public health issues associated with nutrition and healthy eating, and includes research, surveillance and evaluation to support these activities.

Document Types: public opinion research, surveillance and monitoring documentation, research proposals, analysis, and reports, correspondence, presentations, contracts with collaborators, briefing notes, research files of published and unpublished data, strategic policy advice, policies, fact sheets, committee agendas, reports and minutes, educational and promotional materials, outreach documentation, food and nutrition guidelines.

Record Number: HC FSN 010

Great Lakes Health Effects Cohort Study

Description: This bank contains basic personal information, fish consumption patterns, household income, current employment information (kind of work, exposures in the workplace), and medical history data on a sample of Ontario Sport Fish License holders (1988) and their families.

Note: Pending TBS approval.

Class of Individuals: Phase I: 1988 Ontario Sport Fish License holders (approximately 1,000,000). Phase II: A sub-sample of Phase I, plus adult and child members of their household (approximately 100,000 records). Phase III: Further data on a sub-sample of Phase II.

Purpose: The data were collected for research and statistical purposes as part of a study designed to investigate the adverse health effects of Great Lakes water pollution as bio-concentrated by fish.

Consistent Uses: The data collected were intended to be used to determine the risk of cancer, adverse reproductive outcomes (for example, birth defects) and mortality from certain causes associated with consumption of fish caught in the Great Lakes Basin. The individuals identified in the data bank may be followed up over time by linkage to cancer incidence, congenial anomaly or mortality registries. However, due to budgetary and other constraints this may not be done.

Retention and Disposal Standards: Retained a minimum of ten years, and then reviewed for possible transfer to Library and Archives Canada (excluding questionnaires, which may be destroyed after two years).

RDA Number: 2015/022

Related Record Number: HC FSN 010

TBS Registration: 004100

Bank Number: HC PPU 076


Fish & Wildlife Nutrition Project in Areas of Concern

Description: This bank contains information about Ontario anglers and consumers of aquatic wildlife in areas of concern. These groups may not be licensed or may otherwise be outside the mainstream due to language or ethnicity. Information includes name, address, telephone number, gender, marital status, country of birth, fish and aquatic wildlife consumption patterns, household income and language spoken in the home.

Note: Pending TBS approval.

Class of Individuals: Ontario anglers and consumers of fish and aquatic wildlife in selected geographic locations.

Purpose: The purpose of this bank is to conduct research into fish and aquatic wildlife consumption patterns among high-risk Ontario anglers and consumers.

Consistent Uses: Information may be used to contact these individuals in follow-up surveys.

Retention and Disposal Standards: Retained a minimum of ten years, and then reviewed for possible transfer to Library and Archives Canada (excluding questionnaires which may be destroyed after two years).

RDA Number: 2015/022

Related Record Number: HC FSN 010

TBS Registration: 004099

Bank Number: HC PPU 079

Health Impacts of Chemicals

The Health Impacts of Chemicals Program aims to protect the health of Canadians, through the assessment and management of health risks associated with environmental contaminants. The Program conducts risk assessments on both new and existing chemicals as well as products of biotechnology. The Program further supports research, monitoring and surveillance initiatives, and provides expert advice and guidelines on the health impacts of substances. Through national outreach activities, such as the Healthy Home website, the Program provides information to Canadians to help protect children and others from chemicals of concern and pollutants. In addition to chemicals management under the Canadian Environmental Protection Act, 1999, the Program also supports the assessment of environmental risks and health implications of substances under the Pest Control Products Act, Food and Drugs Act and Canada Consumer Product Safety Act. This Program also provides guidance and training for assessing risks to human health posed by environmental risks at federal contaminated sites and provides expertise in support of federal assessments of the impacts of planned major infrastructure projects. Finally, the Program provides technical support for responses to chemical emergencies when federal assistance is required. This Program contributes to Health Canada's Health Protection & Promotion Core Responsibility.

Safe Environments and Environmental and Radiation Health Sciences - Chemicals

Description: Includes records related to research, regarding potential risks to human health posed by existing substances in Canada, under the Canadian Environmental Protection Act (1999) and the Chemicals Management Plan. Records relate to the maintenance of the www.canada.ca/en/health-canada/services/chemical-substances.html website and the Federal Contaminated Sites Action Plan.

Document Types: public opinion research, health hazard assessments and evaluations, surveillance and monitoring documentation, research proposals, analysis, and reports, lab test results, correspondence, presentations, contracts with collaborators, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, fact sheets, questionnaires, briefing notes, summaries, committee agendas, reports and minutes, advisories, educational and outreach bulletins and documentation.

Record Number: HC ERH 035

Ontario Farm Family Health Study

Description: Information collected from 2000 farm families, including name, address, religion, age, sex, and country of birth, farm characteristics, chronic disease and accident histories of farm families participating in this study.

Class of Individuals: Ontario Farm Families.

Purpose: Information is collected for use in a study designed to assess potential exposures on the farm and health effects.

Consistent Uses: Research and Statistical Purposes.

Retention and Disposal Standards: Under Review at LAC - ten years.

RDA Number: 2015/022

Related Record Number: HC ERH 035

TBS Registration: 004104

Bank Number: HC PPU 037


Pesticide Exposure Assessment Pilot Study

Description: Contains the name, address, sex, sample date, sample type (urine, semen, and drinking water), pesticide handling practices of applicator, and pesticides used for farm families participating in this study.

Class of Individuals: Ontario farm families selected from the previous Ontario Farm Family Health Study (Personal Information Bank HCPPU037).

Purpose: Measure the extent to which applicators and family members are exposed to herbicides during normal handling activities on Ontario farms.

Consistent Uses: Research and statistical purposes. Data is linked to HC PPU 037 Ontario Farm Family Health Study.

Retention and Disposal Standards: Under Review at LAC.

RDA Number: 2015/022

Related Record Number: HC ERH 035

TBS Registration: 004105

Bank Number: HC PPU 035


St. Lawrence Vision 2000 Health Components Project

Description: Contains information about persons tested or interviewed pursuant to a number of research projects in the Health Component of the St. Lawrence Vision 2000 program. May include name, address, marital status, sex, language, date of birth, education, income and employment data, food and nutritional profiles, immigration data, health data, alcohol and cigarette consumption, reproductive and fertility histories, and certain very specific recreational activities. Samples may include hair, blood, urine, semen and placental tissue.

Note: Pending TBS approval.

Class of Individuals: Only contains information about persons residing in the immediate vicinity of the St. Lawrence River in Quebec who have been interviewed by investigators.

Purpose: To conduct epidemiological research; to assess health risks associated with certain behaviors and environmental agents; to contribute to future health promotion activities.

Consistent Uses: None. There may be longitudinal surveys of some respondents.

Retention and Disposal Standards: Under Review at LAC - ten years.

RDA Number: 2015/022

Related Record Number: HC ERH 035

TBS Registration: 004109

Bank Number: HC PPU 084


Technical Support Files

Description: This bank contains environmental health surveillance reports, as well as results of tests performed on biological samples (blood, hair, urine) of individuals. Persons seeking access to this bank must supply their full name, the date the sample was submitted and the community where tested. Aboriginals should provide their Band Number.

Class of Individuals: Exposed Aboriginal populations and federal government employees.

Purpose: This bank is used to monitor the health of individuals exposed to a wide variety of environmental and occupational hazards such as dust, mercury, PCB's, arsenic and lead.

Consistent Uses: Information may be used internally for program management purposes and for purposes of research, planning, evaluation, statistics and for internal audit purposes. Information may also be shared with provincial/territorial departments of health.

Retention and Disposal Standards: Under Review at LAC - ten years.

RDA Number: 2015/022

Related Record Number: HC ERH 035

TBS Registration: 002722

Bank Number: HC PPU 005


Research into the Effects of Chemicals on Humans

Description: This bank describes information that is about individuals who have participated in research concerning the health impact of chemicals and monitoring and/ or surveillance activities that identify and track exposure to chemical hazards in the environment. The personal information may include name, contact information, biographical information, educational information, financial information, medical information, physical attributes and age, ethnicity, personal views or opinions, tobacco use, personal product use, dietary information, participant identification number and consent forms.

Note: In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request form, individuals requesting information described by this bank must provide the name, date and location of the research, monitoring or surveillance activity in which they participated.

Class of Individuals: General public, individuals who volunteer or who are solicited to participate in a particular research, monitoring or surveillance activity.

Purpose: The personal information is used to determine the effects of chemical substances on individuals and to identify and track exposure to chemical hazards. Personal information is collected pursuant to Canadian Environmental Protection Act (1999) and the Department of Health Act.

Consistent Uses: In certain circumstances, limited amounts of personal information may be shared with research monitoring or surveillance partners.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC ERH 035

TBS Registration: 20110506

Bank Number: HC PPU 200

Medical Devices

The program is responsible for ensuring medical devices sold in Canada are safe, effective and of high quality. It verifies that regulatory requirements for the safety, effectiveness and quality of medical devices sold in Canada are met through pre-market application reviews, risk-benefit assessments, monitoring, surveillance, compliance, and enforcement activities. It also provides information to Canadians and health professionals to enable informed decision making about product use. The program aligns with the Departmental Results Framework "Health Protection and Promotion" Core Responsibility and supports the result "Canadians have access to safe, effective and quality health products." Target populations include industry, (including market authorization holders and registered establishments license holders), health professionals and practitioners, and Canadians. Key stakeholder roles are to comply with responsibilities under the Food and Drugs Act and Regulations (industry); to promote the appropriate use of medical devices (health professionals and practitioners); and to report adverse incidents also known as side effects to Health Canada (industry; health care professionals/practitioners; and Canadians).

Medical Devices for Human Use

Description: Includes records relating to the process of federal regulation of medical devices including pre-market submissions, investigational testing and the special access program. Records relate to the identification and assessment of medical device safety risks.

Document Types: application forms, guidance documents, incident and adverse reaction reports, health hazard assessments and evaluations, public opinion research, research proposals, analysis, and reports, correspondence, presentations, contracts with collaborators, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, standard medical device submissions from manufacturers, fact sheets, committee agendas, terms of reference, reports and minutes, notices, notices of early consultation, consultation reports, notices of intent, standard operating procedures, strategic planning framework, Summary Basis of Decision, Regulatory Decision Summary, Summary Safety Review, briefing notes, educational and outreach materials.

Record Number: HC HP 040

Scientific Review and Evaluation Experts

Description: This bank describes information that is related to individuals who have an interest in becoming part of Health Canada's inventory list of qualified external scientific experts. These individuals provide scientific evaluation and advisory services to the department and/or participate as volunteers on Scientific Advisory Committees and/or Panels. The personal information may include name, contact information, biographical information, educational information and language, professional affiliations, publications, area of scientific expertise.

Note: Information may be stored in the following internal systems/databases: Scientific Experts Database.

Class of Individuals: Individuals that deal in health and/or medical sciences, scientists, researchers and academics, who have indicated an interest in working with Health Canada on a contractual or volunteer basis.

Purpose: The personal information is used to establish an inventory of experts to provide scientific evaluation and advisory services to the department and/or participate as a volunteer on scientific advisory committees and/or panels. Personal information is collected pursuant to Section 4 of the Department of Health Act.

Consistent Uses: Personal information may be shared with programs within Health Canada to enhance the department's ability to access external scientific expertise on an as required basis.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC HP 040; HC HP 005

TBS Registration: 20110541

Bank Number: HC PPU 409


Medical Devices Problem Reporting Program

Description: This bank describes information that is collected by Health Canada regarding adverse events related to medical device incidents. The personal information that is collected may include the name, title, mailing address, email address, telephone and fax number of the incident reporter or complainant and information regarding the individual who has experienced the incident including their detailed medical information, the date and location of the incident, description of the incident, date of implantation or explanation, duration of device use, sex/gender/height/weight of the affected person if applicable to the incident, patient consequences and open-ended health information describing the incident/problem/adverse event.

Note: In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request Form, an individual requesting access to information described in this bank is encouraged to provide sufficient information to locate the requested data (for example; initials, the incident ID number, type of device, date and place of the incident).

Class of Individuals: General public, industry employees (manufacturers, importers, distributors), investigational testing organizations, special access users, hospitals, health care facility employees and professionals.

Purpose: Personal information collected from the medical device incident reports by the department may be used to follow-up with reporters of a medical device related incident for compliance and enforcement activities; to request safety and efficacy information from the manufacturers, health care professionals / practitioners / facilities and other users of marketed medical devices for the purpose of post-market surveillance of medical devices; reporting to senior management; complete trend analysis. Personal Information is collected pursuant to the Department of Health Act, Section 4(h), and the Food and Drugs Act, Section23 (1) (c) and the Medical Devices Regulations, Section(s) 59 (1) (a) (b) (2), 60, 61.1 (1), 63, 64 and 65, 77, 81 (k) (v) (2) and 88.

Consistent Uses: Personal information may be used for audit and evaluation purposes. Monitoring, auditing and evaluating these medical device problem reports enables the program to complete safety signal assessments and trend analysis. The program compiles trend and safety data and utilizes it in a de-identified format to identify emerging safety signals/issues and trends, mitigating the risks and improving the safe use and efficacy of medical devices. Trend and safety data in a de-identified format may be communicated by a variety of risk communication tools and (including a monthly Health Canada newsletter – Infowatch and an incident database/data extracts) and / or responses to inquiries.

Retention and Disposal Standards: Retained for seventy-five years after receipt of problem report.

RDA: 2015/022

Related Class of Record Number: HC HP 040, HC HP 045 and HC HP 050

TBS Registration Number: 20150036

Bank Number: HC PPU 415

Marketed Health Products - Medical Devices

Description: Includes records related to the post-market safety of federally regulated and marketed therapeutic health products. Records include information about the Canada Vigilance Program (which collects, processes and monitors adverse reactions), the MedEffect™ Canada Web site, the Canadian Medication Incident Reporting and Prevention program (managed in partnership with the Canadian Institute for Health Information, the Institute for Safe Medication Practices and the Canadian Patient Safety Institute), and documentation supporting the Expert Advisory Committee on the Vigilance of Health Products. Records may be shared with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Document Types: surveillance and monitoring documentation, research proposals, analysis, and reports, product advisories, warnings and recalls, incident and adverse reaction reports, correspondence, memoranda, public relations materials, presentations, research files of published and unpublished data, strategic policy advice, draft regulatory frameworks, risks assessments, briefing notes, information sharing agreements, standards, terms of reference, committee agendas, minutes and reports, educational and outreach materials.

Record Number: HC HP 045

Border Program

Description: This bank describes information that is related to the Border Program. The Border Program conducts compliance and enforcement activities for imported health products (e.g., drugs, natural health products and medical devices) to ensure that they meet the requirements of admissibility under the Food and Drugs Act and its associated Regulations before they are allowed into Canada. The personal information may include name, contact information, customs identifier, licence information, medical information (if related to the importer/exporter), and product information (where it reveals personal information about the importer / exporter).

Note: Information may be stored in the following internal systems / databases: Border Compliance and Operations Database.

Class of Individuals: Individuals who attempt to import or export health products

Purpose: The personal information is used by the Border Program to assess the admissibility of the health product for import / export. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act.

Consistent Uses: Personal information may be used for program evaluation, statistical, compliance and enforcement purposes [HC PPU 402; HC PPU 405; HC PPU 406; HC PPU 407; HC PPU 408] and shared with the Special Access Program [HC PPU 414; HC PPU 430] and the Canada Border Services Agency.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 005, HC HP 020, HC HP 035, HC HP 045, HC HP 050, HC HP 065

TBS Registration: 20210026

Bank Number: HC PPU 436


Special Access Program - Medical Devices

Description: This bank describes information that is related to Health Canada's Special Access Program, which provides access to non-marketed medical devices for practitioners to use on patients for emergency use, or if conventional therapies have failed, are unavailable or unsuitable. The Special Access Program authorizes a manufacturer to sell medical devices not approved for sale in Canada. The personal information may include doctor name and contact information, signature, practitioner license number, patient initials, description of and response to previous treatments, and unexpected adverse reactions, and other medical information.

Note: A practitioner must initiate a request on behalf of a patient. Requests that are denied authorization are returned by fax to the practitioner with an explanation. In all cases, the manufacturer has the final say as to whether or not they will respond to the authorization and supply the device.

Class of Individuals: Special Access Program participants including doctors and patients.

Purpose: The personal information is used to administer the Special Access Program, to determine if the sale of a non-marketed device will be authorized for the practitioner's patient. Personal information is collected pursuant to Part II of the Medical Devices Regulations

Consistent Uses: Personal information may be used for audit and evaluation purposes. Limited personal information including physician contact information (name, address, phone, and fax) may be shared by medical device manufacturers as necessitated by the requirements of the program.

Retention and Disposal Standards: Retained for fifty years after device has been released.

RDA Number: 2015/022

Related Class of Record Number: HC HP 045

TBS Registration: 20130063

Bank Number: HC PPU 430


Medical Devices Problem Reporting Program

Description: This bank describes information that is collected by Health Canada regarding adverse events related to medical device incidents. The personal information that is collected may include the name, title, mailing address, email address, telephone and fax number of the incident reporter or complainant and information regarding the individual who has experienced the incident including their detailed medical information, the date and location of the incident, description of the incident, date of implantation or explanation, duration of device use, sex/gender/height/weight of the affected person if applicable to the incident, patient consequences and open-ended health information describing the incident/problem/adverse event.

Note: In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request Form, an individual requesting access to information described in this bank is encouraged to provide sufficient information to locate the requested data (for example; initials, the incident ID number, type of device, date and place of the incident).

Class of Individuals: General public, industry employees (manufacturers, importers, distributors), investigational testing organizations, special access users, hospitals, health care facility employees and professionals.

Purpose: Personal information collected from the medical device incident reports by the department may be used to follow-up with reporters of a medical device related incident for compliance and enforcement activities; to request safety and efficacy information from the manufacturers, health care professionals / practitioners / facilities and other users of marketed medical devices for the purpose of post-market surveillance of medical devices; reporting to senior management; complete trend analysis. Personal Information is collected pursuant to the Department of Health Act, Section 4(h), and the Food and Drugs Act, Section23 (1) (c) and the Medical Devices Regulations, Section(s) 59 (1) (a) (b) (2), 60, 61.1 (1), 63, 64 and 65, 77, 81 (k) (v) (2) and 88.

Consistent Uses: Personal information may be used for audit and evaluation purposes. Monitoring, auditing and evaluating these medical device problem reports enables the program to complete safety signal assessments and trend analysis. The program compiles trend and safety data and utilizes it in a de-identified format to identify emerging safety signals/issues and trends, mitigating the risks and improving the safe use and efficacy of medical devices. Trend and safety data in a de-identified format may be communicated by a variety of risk communication tools and (including a monthly Health Canada newsletter – Infowatch and an incident database/data extracts) and / or responses to inquiries.

Retention and Disposal Standards: Under development.

RDA: 2015/022

Related Class of Record Number: HC HP 040, HC HP 045 and HC HP 050

TBS Registration Number: 20150036

Bank Number: HC PPU 415

Compliance and Enforcement Activities related to - Medical Devices

Description: Includes records related to compliance and enforcement activities for medical devices. Records include documentation used for compliance monitoring, and compliance verification and investigation, supported by establishment licensing of medical devices, and laboratory analysis.

Document Types: Inspection and investigation documentation and reports, correspondence, memoranda, public relations materials, presentations, contracts with collaborators, information sharing agreements, strategic policy advice, licenses, report of examination for customs entries, briefing notes, risks assessments, laboratory data, purchasing orders and sales receipts and reports.

Record Number: HC HP 050

Border Program

Description: This bank describes information that is related to the Border Program. The Border Program conducts compliance and enforcement activities for imported health products (e.g., drugs, natural health products and medical devices) to ensure that they meet the requirements of admissibility under the Food and Drugs Act and its associated Regulations before they are allowed into Canada. The personal information may include name, contact information, customs identifier, licence information, medical information (if related to the importer/exporter), and product information (where it reveals personal information about the importer / exporter).

Note: Information may be stored in the following internal systems / databases: Border Compliance and Operations Database.

Class of Individuals: Individuals who attempt to import or export health products

Purpose: The personal information is used by the Border Program to assess the admissibility of the health product for import / export. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act.

Consistent Uses: Personal information may be used for program evaluation, statistical, compliance and enforcement purposes [HC PPU 402; HC PPU 405; HC PPU 406; HC PPU 407; HC PPU 408] and shared with the Special Access Program [HC PPU 414; HC PPU 430] and the Canada Border Services Agency.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 005, HC HP 020, HC HP 035, HC HP 045, HC HP 050, HC HP 065

TBS Registration: 20210026

Bank Number: HC PPU 436


Compliance and Enforcement - Medical Devices

Description: This bank describes information that is used in support of compliance monitoring and enforcement activities related to medical devices. Medical devices cover a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical conditions. Potential non-compliance may be identified by consumer complaints, industry complaints, referrals from other provincial and federal regulatory agencies, international partners or Health Canada's compliance monitoring activities. The personal information may include name, contact information, biographical information, date of birth, date of death, medical information, other identification numbers, physical attributes, purchasing orders, sales receipts, place of death, hospital where patient was treated, and their doctor's name.

Note: In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request form, individuals requesting information described by this bank must provide the incident ID number, device name or company name.

Class of Individuals: General public, industry employees (manufacturers, importers & distributors), and healthcare facility employees / professionals.

Purpose: The personal information is used in support of Health Canada's compliance and enforcement activities related to medical devices. Personal information is collected pursuant to section 23(1)(c) of the Food and Drugs Act and Medical Device Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: audit and evaluation, enforcement, safety and other personal information may be shared with the Canada Border Services Agency (CBSA) [CBSA PPU 035] or the Royal Canadian Mounted Police (RCMP) [RCMP PPU 005] for a specific individual who has been identified as having potential for non-compliance with the Food and Drugs Act and its associated Regulations. Personal information collected during inspections and investigations may be shared with law enforcement agencies for law enforcement and criminal investigation purposes, with other areas of Health Canada [HC PPU 088, HC PPU 415 and HC PPU 045] for the administration of other acts under which the medical devices is regulated with provincial (or territorial) health professional regulatory bodies for follow-up, and/or with foreign regulatory counterparts for the consistent regulation of health products on the international stage.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 050

TBS Registration: 20110501

Bank Number: HC PPU 405

Natural Health Products

The program is responsible for administering an efficient and transparent regulatory system that enhances consumer safety, reduces regulatory burden, fosters innovation and accountability, and helps deliver health options to Canadians. This includes a progressive regulatory framework whereby regulatory decisions are weighed by certainty and risk levels, are evidence based and transparent, and provide assurance to Canadians that products sold in Canada are safe, effective and of high quality while respecting freedom of choice and cultural and philosophical diversity. The program develops and maintains relationships with international regulatory partners, industry stakeholders and advisory committees. It aligns with the Departmental Results Framework "Health Protection and Promotion" Core Responsibility and supports the result "Canadians have access to safe, effective and quality health products." Target populations include regulated parties, stakeholders and Canadians. Regulated parties comply with the Food and Drugs Act, regulations and Canadian sites that manufacture, package, label and import products. Stakeholders promote Natural Health Product (NHP) use, provide information to the program to make informed decisions, use Health Canada information for stakeholder interactions, conduct research and promote health campaigns. Canadians rely on Health Canada to have access to NHPs that are safe, effective and of high quality, and information to make informed decisions.

Natural Health Products

Description: Includes records related to the regulation of natural health products available to Canadians for human use, including the process to obtain approval to sell natural health products under the Natural Health Products Regulations, product and site licences, as well as clinical trial applications. Records include documentation created in support of the Natural Health Products Program Advisory Committee regarding the safety, quality and efficacy of natural health products for sale in Canada.

Document Types: public opinion research, incident and adverse reaction reports, health hazard assessments and evaluations, product approval applications and submissions, research proposals, analysis and reports, correspondence, presentations, contracts with collaborators, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, standard natural health product submissions from manufacturers, product and site licenses, fact sheets, committee reports and minutes, product advisories, warnings and recalls, education and outreach documentation.

Record Number: HC HP 055

Marketed Health Products - Natural Health Products

Description: Includes records related to the post-market safety of federally regulated and marketed natural health products. Records include information about the Canada Vigilance Program, the MedEffect™ Canada Web site, the Canadian Medication Incident Reporting and Prevention Program, and documentation supporting the Expert Advisory Committee on the Vigilance of Health Products.

Document Types: public opinion research, surveillance and monitoring documentation, research proposals, analysis and reports (including pre-clinical and clinical studies), correspondence, memoranda, public relations materials, presentations, contracts with collaborators, information sharing agreements, lab test results, briefing notes, patents, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risks assessments, standards, product evaluations, submissions from manufacturers, establishment licensing, educational and outreach materials.

Record Number: HC HP 060

Compliance and Enforcement Activities related to - Natural Health Products

Description: Includes records related to compliance and enforcement activities for Natural Health Products. Records include documentation used for compliance monitoring, and compliance verification and investigation, supported by site licensing of Natural Health Products, and laboratory analysis.

Document Types: Inspection and investigation documentation and reports, correspondence, memoranda, public relations materials, presentations, contracts with collaborators, information sharing agreements, strategic policy advice, licenses, report of examination for customs entries, briefing notes, risks assessments, laboratory data, purchasing orders and sales receipts and reports.

Record Number: HC HP 065

Border Program

Description: This bank describes information that is related to the Border Program. The Border Program conducts compliance and enforcement activities for imported health products (e.g., drugs, natural health products and medical devices) to ensure that they meet the requirements of admissibility under the Food and Drugs Act and its associated Regulations before they are allowed into Canada. The personal information may include name, contact information, customs identifier, license information, medical information (if related to the importer/exporter), and product information (where it reveals personal information about the importer / exporter).

Note: Information may be stored in the following internal systems / databases: Border Compliance and Operations Database.

Class of Individuals: Individuals who attempt to import or export health products

Purpose: The personal information is used by the Border Program to assess the admissibility of the health product for import / export. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act.

Consistent Uses: Personal information may be used for program evaluation, statistical, compliance and enforcement purposes [HC PPU 402; HC PPU 405; HC PPU 406; HC PPU 407; HC PPU 408] and shared with the Special Access Program [HC PPU 414; HC PPU 430] and the Canada Border Services Agency.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 005, HC HP 020, HC HP 035, HC HP 045, HC HP 050, HC HP 065

TBS Registration: 20210026

Bank Number: HC PPU 436


Compliance and Enforcement - Natural Health Products

Description: This bank describes information that is used in support of compliance monitoring and enforcement activities related to natural health products as defined under the Food and Drugs Act and the Natural Health Products Regulations. Potential non-compliance may be identified by consumer complaints, industry complaints, referrals from other provincial and federal regulatory agencies, international partners or Health Canada's compliance monitoring activities. The personal information may include name, contact information, date of death, medical information, physical attributes, purchasing orders, sales receipts, and written details associated with complaints submitted by the public (what, when, where, who and how something happened) purchasing orders, and sales receipts.

Class of Individuals: General public, regulated parties under the Food and Drugs Act and the Natural Health Products Regulations (for example, manufacturers submitting trade complaints).

Purpose: The personal information is used to support Health Canada's compliance and enforcement activities, including inspections and investigations, related to natural health products. Personal information is collected pursuant to section 23(1)(c) of the Food and Drugs Act and Natural Health Products Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: audit and evaluation, compliance and enforcement, safety and other personal information may be used to inform the Canada Border Services Agency (CBSA) [CBSA PPU 035] to target a specific individual who has been identified as having potential for non-compliance with the Food and Drugs Act and Natural Health Products Regulations. Personal information collected during inspections and investigations may be shared with law enforcement agencies for law enforcement and criminal investigation purposes, with other branches or directorates of Health Canada [HC PPU 088, HC PPU 415 and HC PPU 045] for the administration of other acts under which the natural health product is regulated, with provincial (or territorial) health professional regulatory bodies when the health and safety of Canadians may be impacted due to a non-compliance under a different regulatory jurisdiction, and/or with Health Canada's foreign regulatory counterparts which have similar mandates for the consistent regulation of health products on the international stage.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 065

TBS Registration: 20110500

Bank Number: HC PPU 406

Pesticides

The objective of the Pesticide Program is to protect the health and safety of Canadians and the environment, relating to the use of pesticides. The Pest Control Products Act provides Health Canada with the authority to regulate pesticides under the Pesticides program. In the delivery of this program, Health Canada conducts activities that span the lifecycle of a pesticide, including: product assessment for health and environmental risks and value; risk management; post market surveillance, compliance and enforcement; changes in use, cancellation, or phase out of products that do not meet current standards; and, consultations and public awareness building. Health Canada is also an active partner in international efforts to align regulatory approaches. These engagements provide access to the best science available to support regulatory decisions and promote consistency in the assessment of pesticides. This program supports the Health Protection and Promotion core responsibility.

Monitoring and Regulation of Pesticide Use

Description: Includes records related to pest management regulation, science-based evaluations of risks, product reviews and registration decisions, documentation in support of compliance and enforcement activities, regulatory processes and control strategies. Also includes records related to collaboration with territorial, provincial, federal and international partners; supporting tools and information for the management of the Public Registry, the repository of non-confidential information on registered and proposed pesticides.

Document Types: public opinion research, product reviews, medical research records, incident reports, compliance and enforcement inspection and investigation reports and related documentation, applications and product registrations, research proposals, analysis, and reports, correspondence, complaints, presentations, contracts with collaborators, research files of published and unpublished data, strategic policy advice, draft legislation and regulatory frameworks, risk assessments, fact sheets, briefing notes, committee agenda, reports and minutes, pesticide advisories, educational and outreach documentation.

Record Number: HC PS 005

Pesticide Incident Reporting

Description: This bank describes information that is related to reportable pesticide incidents. A pesticide incident is any unintended or unexpected effect to humans, animals (including pets or wildlife) or plants (including both terrestrial and aquatic), resulting from exposure to, or use of, a pesticide. Incidents must be reported by pesticide company representatives and may be reported by the general public. The personal information may include name and contact information of the incident reporter, medical information, physical attributes, exposure scenario, symptoms, location of incident, and other unsolicited personal information.

Note: Information may be stored in the following internal systems / databases: The Public Engagement Portal (PEP)  and the Electronic Pesticide Regulatory System (ePRS). Unsolicited personal information is destroyed within one year.

Class of Individuals: General public and pesticide company representatives.

Purpose: The personal information is used in support of the pesticide incident reporting program and incident reporter contact information is used for administrative follow up, when necessary. Health Canada evaluates the incident information in conjunction with scientific literature. Evaluation reports summarizing reviews are posted on the Health Canada website. Personal information is collected pursuant to Section 3 of the Pest Control Products Incident Reporting Regulations.

Consistent Uses: Personal information may be used for the following purposes: audit and evaluation, reporting to senior management, enforcing compliance and enforcement of the Pest Control Products Incident Reporting Regulations.

Retention and Disposal Standards: Records will be destroyed ten years after last administrative action.

RDA Number: 2015/022

Related Class of Record Number: HC PS 005

TBS Registration: 20180031

Bank Number: HC PPU 315

Pharmaceutical Drugs

The program is responsible for ensuring pharmaceutical drugs sold in Canada are safe, effective and of high quality. It verifies that regulatory requirements for the safety, efficacy and quality of pharmaceutical drugs sold in Canada are met through pre-market submission reviews, risk-benefit assessments, monitoring, surveillance, compliance, and enforcement activities. It also provides information to Canadians and health professionals to enable informed decision making about product use. The program aligns with the Departmental Results Framework "Health Protection and Promotion" Core Responsibility and supports the result, "Canadians have access to safe, effective and quality health products." Target populations include industry (including market authorization holders, and registered establishments license holders), health professionals and practitioners and Canadians. Key stakeholder roles are to comply with responsibilities under the Food and Drugs Act and Regulations (industry); to promote the appropriate use of pharmaceutical drugs (health professionals and practitioners); and to report adverse reactions also known as side effects to Health Canada (industry; health care professionals/practitioners; and Canadians).

Pharmaceuticals for Human Use

Description: Includes records relating to the process of federal regulation of pharmaceutical drugs and therapeutic health products, including pre-market submissions, clinical trials and the Special Access Program. Records also relate to adverse drug reactions, identification and assessment of human therapeutic products' safety risks.

Document Types: problem and adverse reaction reports, health hazard assessments and evaluations, public opinion research, applications for special access to drugs, applications and submissions for drug approvals, research proposals, analysis, and reports, correspondence, presentations, contracts with collaborators, research files of published and unpublished data, strategic policy advice, regulatory frameworks, risk assessments, standard therapeutic product submissions from manufacturers, fact sheets, committee agenda, reports and minutes, advisories, warnings and recalls, agendas, terms of reference, notices, notices of early consultation, consultation reports, notices of intent, standard operating procedures, strategic planning framework, Summary Basis of Decision, briefing notes, educational and outreach materials.

Record Number: HC HP 005

Border Program

Description: This bank describes information that is related to the Border Program. The Border Program conducts compliance and enforcement activities for imported health products (e.g., drugs, natural health products and medical devices) to ensure that they meet the requirements of admissibility under the Food and Drugs Act and its associated Regulations before they are allowed into Canada. The personal information may include name, contact information, customs identifier, licence information, medical information (if related to the importer/exporter), and product information (where it reveals personal information about the importer / exporter).

Note: Information may be stored in the following internal systems / databases: Border Compliance and Operations Database.

Class of Individuals: Individuals who attempt to import or export health products

Purpose: The personal information is used by the Border Program to assess the admissibility of the health product for import / export. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act.

Consistent Uses: Personal information may be used for program evaluation, statistical, compliance and enforcement purposes [HC PPU 402; HC PPU 405; HC PPU 406; HC PPU 407; HC PPU 408] and shared with the Special Access Program [HC PPU 414; HC PPU 430] and the Canada Border Services Agency.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 005, HC HP 020, HC HP 035, HC HP 045, HC HP 050, HC HP 065

TBS Registration: 20210026

Bank Number: HC PPU 436


Special Access Program - Pharmaceuticals, Biologic and Radio-Pharmaceuticals

Description: This bank describes information that is related to Health Canada's Special Access Program (SAP). The SAP provides access to non-marketed drugs to practitioners who are treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. Under the Food and Drug Regulations Section C.08.010, the Special Access Program authorizes a manufacturer to sell drugs including pharmaceutical, biologic, and radio-pharmaceutical products that cannot otherwise be sold or distributed in Canada. The personal information may include practitioner name and contact information, signature, alternate's contact information, patient initials, date of birth, physical attributes, clinical rationale for non-marketed drug, detailed medical history, description of and response to treatment, and unexpected adverse reactions, and other medical information.

Class of Individuals: Special Access Program participants including patients, practitioners and the practitioner's alternate.

Purpose: The personal information is used authorize or deny a practitioner access to non-marketed drugs, and to monitor the use of and responses to non-marketed drugs. Personal information is collected pursuant to Section C.08.010 of the Food and Drug Regulations.

Consistent Uses: Personal information may be used to inform, audit or evaluate future program decision-making regarding access to a non-marketed drug. Personal information related to adverse drug reactions are reported to the Canada Vigilance Program [HC PPU 088]. In cases involving controlled drugs, personal information is used by the Office of Controlled Substances for issuing permits. Personal information is disclosed to drug manufacturers to inform them that a practitioner is authorized to access specified non-marketed drugs; and for the manufacturer to impose conditions on the sale of a drug to ensure that it is used in accordance with the latest information available (e.g., the manufacturer may restrict the amount of the drug sold, or offer a protocol for the use of the drug). In unique cases, personal information may be used or disclosed to consult internal or external health experts for their advice (e.g. rare disease, oncology).

Retention and Disposal Standards: Retain for 50 years after decision has been issued.

RDA Number: 2015/022

Related Class of Record Number: HC HP 005 and HC HP 025

TBS Registration: 20110560

Bank Number: HC PPU 414


Scientific Review and Evaluation Experts

Description: This bank describes information that is related to individuals who have an interest in becoming part of Health Canada's inventory list of qualified external scientific experts. These individuals provide scientific evaluation and advisory services to the department and/or participate as volunteers on Scientific Advisory Committees and/or Panels. The personal information may include name, contact information, biographical information, educational information and language, professional affiliations, publications, area of scientific expertise.

Note: Information may be stored in the following internal systems/databases: Scientific Experts Database.

Class of Individuals: Individuals that deal in health and/or medical sciences, scientists, researchers and academics, who have indicated an interest in working with Health Canada on a contractual or volunteer basis.

Purpose: The personal information is used to establish an inventory of experts to provide scientific evaluation and advisory services to the department and/or participate as a volunteer on scientific advisory committees and/or panels. Personal information is collected pursuant to Section 4 of the Department of Health Act.

Consistent Uses: Personal information may be shared with programs within Health Canada to enhance the department's ability to access external scientific expertise on an as required basis.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC HP 040; HC HP 005

TBS Registration: 20110541

Bank Number: HC PPU 409


Canada Vigilance Adverse Reaction Program

Description: This bank describes information collected by Health Canada regarding adverse reactions to drugs, natural health products, diagnostic or therapeutic health products, biologics, cells, tissues and organs. The personal information collected may include the name and contact information and signature of the individual reporting the reaction and information regarding the individual who experienced the reaction including their initials, physical attributes, date and place of birth and death, medical information, biographical information, identifying file number, adverse reaction history details and the facility where the individual has received treatment.

Class of Individuals: General public, industry employees (manufacturers, importers, distributors), and health care facility employees/professionals who report adverse reactions and the individuals who experienced the adverse reaction.

Purpose: To assess adverse reaction reports; monitor safety; and enforce relevant legislation(s) where applicable. Information is collected pursuant to the Department of Health Act, section 4; Food and Drug Regulations, Section(s) C.01.017, C.05.014, C.08.010 (b), C.08.008 (c); (i) Safety of Human Cells, Tissues and Organs for Transplantation Regulations; Section 51 (1) Blood Regulations; Sections 109-116, the Natural Health Products Regulations; Part 1 and Safety of Sperm and Ova Regulations; sections 69 to 76.

Consistent Uses: Vaccine adverse reaction reports may be disclosed to the provincial or territorial bodies responsible for public health for follow up. Personal information may be used to analyze general trends, report to senior management, as well as audit related programs and services. Trend and safety data in a de-identified format may be communicated by a variety of risk communication tools and / or responses to inquiries. A subset of de-identified Canada Vigilance data is made publicly available from the Canada Vigilance Adverse Reaction Online Database. Personal information may be shared with the Public Health Agency of Canada, Canadian Medication Incident Reporting and Prevention (managed in partnership with the Canadian Institute for Health Information), the Institute for Safe Medication Practices, the Canadian Safety Institute, and international regulatory and health product monitoring authorities, for monitoring adverse reactions.. In limited and specific circumstances, personal information may be disclosed to law enforcement where disclosure is necessary for the purpose of eliminating or reducing a significant risk of serious bodily harm to a person or group of persons.

Retention and Disposal Standards: Retained for seventy five years after receipt of adverse reaction report.

RDA Number: 2015/022

Related Record Number: HC HP 005; HC HP 025

TBS Registration: 20180018

Bank Number: HC PPU 417

Veterinary Drugs

Description: Includes records related to policies and processes for the federal regulation of veterinary drugs, pre-market veterinary drug submissions, experimental studies and the Emergency Drug Release program. Records also relate to adverse drug reactions, and the identification and assessment of veterinary drugs safety risks.

Document Types: Submissions and evaluations of veterinary drugs, health hazard assessments and evaluations, surveillance and monitoring documentation, requests for emergency drug release, research proposals, analysis, and reports, correspondence, presentations, contracts with service providers/collaborators, published and unpublished research data, program policies, procedures and guidance documents, briefing documents for senior management, policy and regulatory consultation documents and responses, public opinion research; committee terms of reference, agendas and reports; adverse reaction reports, advisories and recalls, educational and outreach materials.

Record Number: HC HP 010

Marketed Health Products for Pharmaceutical Drugs

Description: Includes records related to the post-market safety of federally regulated and marketed pharmaceutical drugs.

Document Types: surveillance and monitoring documentation, research proposals, analysis and reports, correspondence, memoranda, public relations materials, presentations, product monographs, research files of published and unpublished data, strategic policy advice, draft regulatory frameworks, product monographs, product advisories, warnings and recalls, briefing notes, risks assessments and standards, educational and outreach materials.

Record Number: HC HP 015

Compliance and Enforcement Activities for - Pharmaceutical Drugs

Description: Includes records related to compliance and enforcement activities for pharmaceutical drugs. Records include documentation used for compliance monitoring, and compliance verification and investigation, including establishment licensing of pharmaceutical drugs, and laboratory analysis.

Document Types: Inspection and investigation documentation and reports, correspondence, memoranda, public relations materials, presentations, contracts with collaborators, information sharing agreements, strategic policy advice, licences, compliance reports, report of examination for customs entries, briefing notes, risk assessments, standards, product evaluations, monitoring logs, laboratory data, purchasing orders and sales receipts.

Record Number: HC HP 020

Border Program

Description: This bank describes information that is related to the Border Program. The Border Program conducts compliance and enforcement activities for imported health products (e.g., drugs, natural health products and medical devices) to ensure that they meet the requirements of admissibility under the Food and Drugs Act and its associated Regulations before they are allowed into Canada. The personal information may include name, contact information, customs identifier, licence information, medical information (if related to the importer/exporter), and product information (where it reveals personal information about the importer / exporter).

Note: Information may be stored in the following internal systems / databases: Border Compliance and Operations Database.

Class of Individuals: Individuals who attempt to import or export health products

Purpose: The personal information is used by the Border Program to assess the admissibility of the health product for import / export. Personal information is collected pursuant to 23(1)(c) of the Food and Drugs Act.

Consistent Uses: Personal information may be used for program evaluation, statistical, compliance and enforcement purposes [HC PPU 402; HC PPU 405; HC PPU 406; HC PPU 407; HC PPU 408] and shared with the Special Access Program [HC PPU 414; HC PPU 430] and the Canada Border Services Agency.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 005, HC HP 020, HC HP 035, HC HP 045, HC HP 050, HC HP 065

TBS Registration: 20210026

Bank Number: HC PPU 436


Compliance and Enforcement - Pharmaceutical Drugs

Description: This bank describes information that is used in support of compliance monitoring and enforcement activities related to pharmaceutical human and veterinary drugs as defined under the Food and Drugs Act and the Food and Drugs Regulations. Potential non-compliance may be identified by consumer complaints, industry complaints, referrals from other provincial and federal regulatory agencies, international partners or Health Canada's compliance monitoring activities. The personal information may include name, contact information, biographical information, date of death, educational information, medical information, physical attributes, place of death and written details associated with complaints submitted by the public (what, when, where, who and how something happened), purchasing orders, and sales receipts.

Class of Individuals: General public, industry employees (manufacturers, importers & distributors), and healthcare facility employees/professionals.

Purpose: The personal information is used to support Health Canada's compliance and enforcement activities, including inspections and investigations, related to human or veterinary drugs. Personal information is collected pursuant to section 23(1)(c) of the Food and Drugs Act and Food and Drug Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: audit and evaluation, compliance and enforcement, safety and other personal information may be used to inform the Canada Border Services Agency (CBSA) [CBSA PPU 035] to target a specific individual who has been identified as having potential for non-compliance with the Food and Drugs Act and its associated Regulations. Personal information is collected, audited and evaluated during inspections and investigations may be shared with law enforcement agencies for law enforcement and criminal investigation purposes, with other branches or directorates of Health Canada [HC PPU 088, HC PPU 415 and HC PPU 045] for the administration of other acts under which the human or veterinary drug is regulated, with provincial (or territorial) health professional regulatory bodies when the health and safety of Canadians may be impacted due to non-compliance under a different regulatory jurisdiction, and/or with Health Canada's foreign regulatory counterparts which have similar mandates for the consistent regulation of health products on the international stage.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC HP 020

TBS Registration: 20110499

Bank Number: HC PPU 407

Radiation Protection

The program objectives are to inform and advise Canadians, as well as other Canadian government departments and stakeholders (provinces/territories, health professionals and associations, industry, etc.), about the health risks associated with radiation, and strategies to manage those risks. The key activities of the program are monitoring environmental and occupational radiation; collaborating with international partners; managing federal nuclear emergency preparedness and response (including plans, procedures and training) for nuclear emergencies that require a coordinated federal response; educating Canadians and stakeholders on the health risks of radon and on risk mitigation strategies; conducting radiation-related research; and regulating radiation emitting devices. In addition, the program is licensed under the Nuclear Safety and Control Act to deliver the National Dosimetry Service, which provides cost-recovered occupational radiation monitoring services to clients. The program supports the Departmental core responsibility of Health Protection and Promotion by assessing, managing and communicating the health and safety risks associated with radiation exposure from both natural and man-made sources. The Department of Health Act, the Radiation Emitting Devices Act, the Comprehensive Nuclear Test Ban Treaty Implementation Act, the Emergency Management Act and the Nuclear Safety and Control Act and Regulations provide the authority for the Radiation Protection program.

Environmental and Radiation Health Sciences - Passenger Conveyances

Description: Includes records related to research on environmental and radiation safety on public conveyances; draft regulations and guidelines to reduce radiation risks personnel and the general public; records related to collaboration with other government departments and agencies, industry, and the general public.

Document Types: public opinion research, health hazard assessments and evaluations, surveillance and monitoring documentation, research proposals, analysis, and reports, lab test results, correspondence, presentations, contracts with collaborators, research files of published and unpublished data, strategic policy advice, guidelines, draft legislation and regulatory frameworks, risk assessments, fact sheets, questionnaires, briefing notes, summaries, committee agendas, reports and minutes, advisories, educational and outreach documents.

Record Number: HC ERH 050

Environmental Radiation Monitoring and Protection Program

Description: Includes records related to radon, and other naturally occurring sources of radiation as well as technological sources of radioactivity. Records may include assessments of 'priority' government buildings for adherence to guideline radiation limits; monitoring documentation for environmental radiation for evidence of any nuclear incident; and guidance documentation that addresses environmental radiation that poses a risk to public health.

Document Types: public opinion research, health hazard assessments and evaluations, surveillance and monitoring documentation, research proposals, analysis, and reports, radiation readings, lab test reports, questionnaires, correspondence, presentations, contracts with service providers and collaborators, research files of published and unpublished data, drafts and published peer reviewed papers, strategic policy advice, briefing notes, risk assessments, fact sheets, memorandum of understanding, committee agenda, reports and minutes, advisories, educational and outreach documentation.

Record Number: HC RP 005

Biological Dosimetry Service

Description: This bank describes information that is related to laboratory testing and reporting performed by Health Canada in assessing suspected occupational and or accidental overexposure to radiation. This activity is undertaken in circumstances identified by the Canadian Nuclear Safety Commission and Canadian Space Agency. The personal information may include name, contact information, biometric information, date of birth, medical information, physical attributes, signature and smoking and radiation exposure history, consent forms and blood samples.

Class of Individuals: General public, nuclear energy workers and astronauts.

Purpose: The personal information is used to assess individuals who require testing for overexposure to radiation and to report back the results to the requester; all other personal information is used to assist in the interpretation of results of dose assessments. Personal information is collected pursuant to the Department of Health Act.

Consistent Uses: The information may be used or disclosed for audit and evaluation purposes. With consent, personal information may be disclosed to the Canadian Nuclear Safety Commission or the Canadian Space Agency.

Retention and Disposal Standards: Under Review at LAC - eighty years.

RDA Number: 2015/022

Related Class of Record Number: HC RP 005

TBS Registration: 20110505

Bank Number: HC PPU 312

Radiation Emitting Devices Administration and Enforcement

Description: Includes records relating to the administration and enforcement of the Radiation Emitting Devices Act, including hazard and health risk assessments and measurements to support management of the risks associated with radiation-emitting devices (e.g., X-rays, microwaves, lasers). Records also include research into the biological effects of radiation, inspection notes, guidelines, standards and safety codes. Records include documents that detail collaboration with other Health Canada programs, federal departments and provincial authorities, and documentation related to the Federal Provincial Territorial Radiation Protection Committee.

Document Types: public opinion research, health hazard assessments and evaluations, surveillance and monitoring documentation, research proposals, analysis, and reports, correspondence, questionnaires, radiation readings, lab test results, medical files, presentations, contracts with service providers and collaborators, research files of published and unpublished data, strategic policy advice, briefing notes, draft legislation, regulatory frameworks, risk assessments, fact sheets, summaries, guidelines, standards, committee agendas, reports and minutes, advisories, educational and outreach bulletins and other documentation.

Record Number: HC RP 010

Biological and Other Research Related to Radiation

Description: This bank describes information that is related to research or studies undertaken to determine the biological and other effects of radiation. The personal information may include name, contact information, biographical information, biometric information, date of birth, educational information, financial information, medical information, physical attributes, place of birth, signature, smoking and radiation history, medical history, behaviors, habits and mood information, consent forms, and blood, urine, saliva and hair samples.

Note: In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request form, individuals requesting information described by this bank must provide the name, location and year of research or study.

Class of Individuals: General public/any individuals, who volunteer or who come forward from recruitment programs.

Purpose: The personal information is used to assess the biological health effects caused by radiation, develop new methods/techniques for biologically based dose assessments and determine short and long term health effects of various radiation emitting devices. Personal information is collected pursuant to the Department of Health Act and the Radiation Emitting Devices Act.

Consistent Uses: The information may be used or disclosed for the following purposes: Other: With consent, personal information is used to re-contact individuals for follow-up if necessary and for further risk assessment; aggregate data is used for program evaluation and published reports. Blood samples connected to age and gender information may be shared with research partners.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC RP 010

TBS Registration: 20110507

Bank Number: HC PPU 310

Dosimetry Services for Occupational Exposures to Radiation

Description: Includes records that relate to monitoring and reporting on occupational radiation exposure; research data to help improve workplace practices and safety standards and to educate Canadians on issues of exposure to radiation in the workplace; dose records for all monitored radiation workers in Canada; evaluations of dose trends and statistical analysis. This information may be shared with regulatory authorities to notify them of overexposures within their jurisdiction.

Document Types: public opinion research, health hazard assessments and evaluations, research proposals, analysis, and reports, correspondence, medical files, radiation exposure reports, presentations, contracts with service providers and collaborators, research files of published and unpublished data, strategic policy advice, statistical data and analysis reports, regulatory frameworks, risk assessments, fact sheets, committee agenda, reports and minutes, briefing notes, educational and outreach documentation.

Record Number: HC RP 015

National Dose Registry (NDR) for Occupational Exposures

Description: This bank describes information that is related to individuals who may have occupational exposures to ionizing radiation. The personal information is collected from third party dosimetry service providers. Personal information includes the worker's given names, surname and any previous surname; Social Insurance Number (SIN); gender; job category; work history; the date, province and country of birth; whether or not the worker is pregnant and the pregnancy start date; the amount of exposure to radon progeny; and the effective dose and equivalent dose received by and committed to the worker, the name and contact information of the worker's current employer.

Class of Individuals: Workers exposed to ionizing radiation in the workplace - either nuclear energy workers (Canadian Nuclear Safety Commission (CNSC) regulated) or non-nuclear energy workers who fall under federal or provincial/territorial jurisdiction.

Purpose: To support the regulatory control of workers to radiation exposures; to assess whether radiation exposure is within regulatory dose limits; to advise employers and the appropriate regulatory authorities that a prescribed dose limit has been exceeded. Personal information is collected under the authority of section (19) of the Radiation Protection Regulations and the Department of Health Act, paragraphs 4(2)(a.1), (b), (c), (d) and (i). The authority for the collection of the SIN can be found under section 19 of the Radiation Protection Regulations and the use by NDR is listed in the TBS Directive on Social Insurance Number.

Consistent Uses: Personal information may be shared with the CNSC (refer to CNSC PPE 802 Radiation Exposure Records: CNSC Staff and CNSC PPU 050 Miner Exposure Database) or Federal or Provincial/Territorial Regulatory Authority for their investigation on the worker's radiation dose exposure. With written consent from the worker, personal information may be disclosed, by employers and provincial Worker Compensation Boards (WCBs). Personal information is disclosed to Statistics Canada for research and statistical purposes. Personal information, excluding the SIN, may be disclosed to research partners, for research and statistical purposes.

Retention and Disposal Standards: Under Review at LAC - eighty years.

RDA Number: 2015/022

Related Record Number: HC RP 015

TBS Registration: 000038

Bank Number: HC PPU 080


National Dosimetry Services (NDS) Division

Description: This bank describes information that is related to individuals who may have occupational exposures to ionizing radiation that have been reported through NSD. The personal information may include worker's given names, surname and previous surname, social insurance number (SIN), sex, job classification, employer, work history, date of birth, province of birth, country of birth if born outside Canada, whether or not the worker is pregnant, the dose received by the worker and the name and contact information of the employer.

Note: The NSD is a cost recovery service that provides occupational radiation dosimetry services to workers in Canada.

Class of Individuals: Workers exposed to ionizing radiation in the workplace - these include nuclear energy workers (regulated by the Canadian Nuclear Safety Commission (CNSC)) or other workers exposed to ionizing radiation who fall under federal or provincial/territorial jurisdiction, as well as emergency responders who respond to a nuclear or radiological emergency in Canada or abroad.

Purpose: The personal information is used to provide dosimetry services to client organizations to monitor occupational radiation exposure of their employees. Other: NSD operates as a Dosimetry Services Provider, licenced by the CNSC under Section 24 of the Nuclear Safety and Control Act.

The Social Insurance Number is collected pursuant to the Section 19 b) of the Radiation Protection Regulations (SOR/2000-203) and is used to link an individual to his/her dose history throughout their career.

Consistent Uses: Personal information is disclosed to the National Dose Registry as required under section 19 of the Radiation Protection Regulations (refer to HVC PPU 080 National Dose Registry (NDR) for Occupational Exposures) Personal information may be shared with the CNSC disclosed for the following purposes: reporting to senior management, safety, evaluation and Other: Personal information is disclosed to the National Dose Registry (NDR) as required under section 19 of the Radiation Protection Regulations (refer to HC PPU 080 National Dose Registry (NDR) for Occupational Exposures). Personal information may be shared with Canadian Nuclear Safety Commission (CNSC); refer to CNSC PPE 802. PIA: No PPIA or PIA has been developed prior to the development of the PIB. The NDS was established in 1954. Health Canada has determined that a PIA was not required and completed instead, a privacy protocol, to assess privacy risks.

Retention and Disposal Standards: Under Review at LAC - eighty years.

RDA Number: 2015/22

Related Class of Record Number: HC RP 015

TBS Registration: 20200011

Bank Number: HC PPU 431

Specialized Health Services and Internationally Protected Persons

The Specialized Health Services consists of two business lines: first, Employee Assistance Services (EAS) delivers the Employee Assistance Program (EAP) to about 80 federal departments and agencies through a network of contracted mental health professionals; and, secondly, the Public Service Occupational Health Program (PSOHP) provides occupational health services and occupational hygiene consultative services to Government of Canada departments and agencies, on behalf of TBS (as employer), to ensure that federal public servants meet medical requirements to safely and effectively perform their duties. The focus of this PIP is on EAP, given its level of performance measurement maturity (PSOHP is currently planning for the implementation of a national information system and concomitant performance measurement strategy). The EAP delivers short-term counselling, referral and follow-up to federal public servants and their immediate families. Services are confidential (except in cases of subpoena, child abuse, or threat of harm to self or others), bilingual, accessible via a 1-800 phone line, available 24 hrs/day, 365 days/year. The Internationally Protected Persons (IPP) Program helps fulfill the Government of Canada's international legal obligations by protecting the health of IPPs (e.g., the Royal Family, heads of state, and other dignitaries) visiting Canada as part of regular visits or participation in international major events (e.g., G7 Summit in 2018).

Specialized Health Services Directorate

Description: Includes records relating to the promotion of a healthy working environment for federal employees, including provision of individual counselling preventative measures and occupational health and safety support. Records relate to the Employee Assistance Services (EAS) Program and its delivery of confidential counselling services and the Public Service Occupational Health Program (PSOHP), which includes the provision of occupational health evaluations, communicable disease-related services, and the maintenance of the Occupational Health Assessment Guide.

Note: The title of this COR used to be Public Service Occupational Health and Safety.

Document Types: applications, medical records including assessments, x-rays, hearing and lab tests and results, consultation reports, treatment plans and recommendations, medical assessments for pre-placement, pre-posting, cross-posting, and returns from-posting, periodic health evaluations, fitness-to-work evaluations, reports, correspondence, memoranda, requests for evaluations and for access to records, public relations materials, presentations, contracts with collaborators/ service providers, information sharing agreements, strategic policy advice, briefing notes, committee agendas and minutes of meetings.

Record Number: HC SHS 005

Public Service Occupational Health Program

Description: This bank describes information that is related to the Public Service Occupational Health Program (PSOHP). The PSOHP provides services as per Treasury Board of Canada Secretariat's Policy on People Management and the Directive on Occupational Health Evaluations. By providing occupational health evaluation services including preplacement, periodic and fitness to work assessments and related ancillary testing (e.g., vision tests, hearing tests), communicable disease advice and services, occupational hygiene consultative services, superannuation assessment-related services and occupational health surveillance, the PSOHP helps federal departments and agencies ensure that public servants meet medical requirements to safely and effectively perform their duties and prevent work-related illness and injury. The personal information may include name, contact information, biographical information, date of birth, employee identification number, employee personnel information, medical information, physical attributes, signature, human biological materials (e.g., blood samples), lab tests and results.

Note: Information may be stored in the following internal systems / databases: National Occupational Health Information System (NOHIS).

Class of Individuals: Current and former federal workers throughout Canada, as well as, those posted overseas, and their dependents, and federal job candidates.

Purpose: The personal information is used to administer the Public Service Occupational Health Program.

Consistent Uses: Personal information is collected pursuant to section 4(2)(f) of the Department of Health Act. The information may be used or disclosed for the following purposes: evaluation, reporting, research, planning, statistics and audit. Following completion of a fitness to work evaluation, both the employer and the employee are provided with a written report concerning the employee's health capacity to carry out the duties of the position and outlining specific limitations or physical restrictions to the employing department. Personal information that enables the employer to take appropriate measures (e.g. information on limitations related to the health requirements of the position) will be disclosed to the employing department. Following all health evaluations, the Health Canada occupational health professional will forward to the employing department and the individual an assessment report indicating whether the individual meets the health requirements of the job. Personal information may also be used and disclosed in response to legal actions and complaints to the Canadian Human Rights Commission about the outcomes of occupational health medical evaluations. Personal information may be shared with federal, provincial and territorial authorities, as required for health professionals' reporting requirements (e.g., reportable communicable diseases, adverse drug/vaccine reactions, seafarer and driver fitness). Personal information related to an employee's eligibility to retire on medical grounds will be shared with the Government of Canada Public Service Pension Centre. Personal information may be disclosed to employing departments for health surveillance purposes, as part of the employing department's workplace hazard prevention program. Following completion of an occupational health surveillance examination/testing, personal information that enables the employer to take appropriate measures (e.g. information on limitations or physical restrictions related to the employee's health in the workplace) will be disclosed to the employing department.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC SHS 005

TBS Registration: 005077

Bank Number: HC PCE 701


Employee Assistance Services

Description: This bank describes information related to the Employee Assistance Services (EAS) including individual and couples crisis and short term counselling, and conflict management training, coaching and mediation for individuals, pairs and groups. Personal information may include name, contact information, employing institution, occupational group, gender, age range, reason for consultation, referral, counselling coaching mediation and training notes, number and date of visits, parental consent for service to minors, signature, views and opinions, counsellor and client numbers, and, depending on issue being discussed, medical information.

Note: Pending TBS approval.

Health Canada provides Employee Assistance Services on behalf of most federal institutions. In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request Form, an individual requesting access to information described in this bank is encouraged to provide sufficient information to locate the requested data (for example; name of service provider, type of service provided, city of service, home department at the time, phone number provided when service was initiated).

Class of Individuals: Current or former federal employees and their families who are eligible and access Employee Assistance Services through Health Canada and their service providers; former clients from non-federal institutions.

Purpose: The personal information is used to determine eligibility for Employee Assistance Services, to provide counselling, coaching, conflict management and mediation services, referrals and to provide training. Some personal information is used to identify service utilization. Personal information is collected pursuant to Department of Health Act 4(2)(f).

Consistent Uses: The information may be used or disclosed for the following purposes: In limited and specific circumstances, personal information may be disclosed to law enforcement officials if child abuse is suspected or if the client threatened harm to themselves or other individuals. With consent, clients may be contacted to assess the services received for quality assurance purposes. Information will be used for program evaluation and service utilization and may be disclosed to client institutions under agreement. Information related to contracted service providers is described PSU 912 Professional Service Contracts, and may be used or disclosed in accordance with that PIB.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC SHS 005

TBS Registration: 20180045

Bank Number: HC PCU 705


Peer Support Program

Description: This bank describes information that is about individuals participating in the peer support program. The objective of the peer support program is to help mitigate an individual's mental health issue/illness by leveraging a trusting relationship between someone who has been living with a mental health problem, directly or indirectly, with a co-worker who has had a similar experience. The personal information may include name, contact information, biographical information, employment equity information, medical information, signature, age, photos, preferred language, authentication password, opinions and views of individuals, and unique file identification number.

Note: Pending TBS approval.

Class of Individuals: CSB employees participating in the Peer Support Program.

Purpose: The personal information is used to administer the peer support program or activity. Personal information is collected pursuant to sections 4(1) and (2)(f) of the Department of Health Act.

Consistent Uses: The information may be used or disclosed for the following purposes: create an inventory of peer support volunteers; program evaluation and reporting to senior management and to provide peer support to employees seeking assistance with mental health issues/illness. Personal information may be shared with 911 authorities in the event of an emergency. Personal information may be shared with a third party service provider contracted to implement and manage the peer support program.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC SHS 005

TBS Registration: 20210005

Bank Number: HC PSE 921

Healthcare Practitioner Regulated Practice

Description: Includes records related to professionals practices, standards and other regulatory requirements; commendations and reprimands; internal and external complaints; views and opinions of colleagues, managers and auditors relating to the healthcare practitioner's professional practices; and general records related to how a practitioner complies with the expectations of their regulatory body. Some records may include patient medical information.

Document Types: reports, chart audits, audit reports, staff reports, correspondence, complaints, practice assessments, professional practice guidelines and standards, performance agreements, learning and development plans, talent management plans, investigation reports, actions plan reports, and medical records including medical assessments.

Record Number: HC DSS 020

Nurse and Healthcare Practitioner Practice and Standards Reviews

Description: This bank describes information that is related to nurses and other healthcare practitioners' professional practice and standards while working for Health Canada in any capacity. The personal information may include name, contact information, complaints concerning the health care practitioner, biographical information, employee personnel information, employee and other identification numbers, educational and certification information, employee practice as a registered professional, medical information, observations, views and opinions of, and about an individual.

Class of Individuals: Employees of Health Canada and individuals who file complaints concerning an employee's professional practices.

Purpose: The personal information is used to evaluate and monitor health care professionals against the requirements of their professional regulatory body and other regulatory requirements to which they are subject in the course of their work and in response to complaints, deaths of patients or regulatory investigations or reviews; to determine their level of skill in fulfilling those requirements including the identification of training and development needs. Personal information is collected pursuant to section 12 of the Financial Administration Act.

Consistent Uses: Personal information may be used for audit and evaluation purposes. To support decisions regarding promotions, transfers, demotion, employee assistance, discipline, termination of employment and administrative investigations. The information may be shared as described in Standard Personal Information Banks the Employee Performance Management Program PSE 912, Internal Audit PSU 941, and Discipline PSE 911. Information may be disclosed to the employee's professional regulatory body.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC DSS 020

TBS Registration: 20150219

Bank Number: HC PPU 022

Tobacco Control

The objective of the Tobacco Control Program is to reduce the prevalence of tobacco use in Canada to less than 5% by 2035 through efforts to prevent the uptake of tobacco and vaping products by youth and non-smokers and to help those who currently use tobacco to quit. This objective supports the department's core responsibility of Health Protection and Promotion by minimizing risks to the health of Canadians associated with the use of tobacco and vaping products. The Program administers the Tobacco and Vaping Products Act, which provides a legal framework for regulating the manufacture, sale, labelling, and promotion of tobacco and vaping products. The Program also leads Canada's Tobacco Strategy, in collaboration with federal partners, which supports scientific research, surveillance, policy and regulatory development, public outreach, and compliance and enforcement activities for tobacco and vaping products. In addition, the Program collaborates with key stakeholders including, but not limited to, provincial and territorial governments, health professionals, and Canadians.

Tobacco

Description: Includes records related to Health Canada activities designed to reduce death and disease associated with tobacco use in Canada, including the regulation of manufacturing, sale, labelling, and promotion of tobacco and vaping products. Records relate to the Federal Tobacco Control Strategy, compliance to the federal Tobacco and Vaping Products Act, including site inspection documentation; cigarette ignition propensity regulations, reports filed by industry under the tobacco reporting regulations and research concerning prohibited additives; documentation to support the development of health warning messages; next generation tobacco control policies.

Document Types: public opinion research, health hazard assessments and evaluations, surveillance and monitoring documentation, applications and submissions, research proposals, analysis, and reports, correspondence, presentations, contracts with collaborators, license agreements, site inspection documentation, research files of published and unpublished data, strategic policy advice, policies, draft legislation and regulatory frameworks, risk assessments, product submissions from manufacturers, fact sheets, questionnaires, briefing notes, committee agendas, reports and minutes, advisories, tobacco warnings, educational and outreach documentation.

Record Number: HC SUA 005

Case-Control Study on Passive Smoking and Lung Cancer

Description: This bank contains demographic information, and information on exposure to passive smoking, familial history of cancer, personal history of respiratory illness, occupational history, diet, environmental exposures, residential history, and radon exposure for about 735 non-smoking lung cancer cases and about 735 controls, across Canada. This bank also contains demographic information on personal smoking history, and a brief occupational history for about 38,000 smoking lung cancer cases across Canada.

Class of Individuals: Individuals diagnosed with primary lung cancer between January 1, 1995 and December 31, 1996 (approx.). Controls matched to non-smoking lung cancer cases.

Purpose: To examine the relationship between exposure to environmental tobacco smoke and the incidence of lung cancer, adjusting for the effects of other potential risk factors including occupation, diet, and environmental radon; to estimate incidence of smoking among lung cancer cases in Canada.

Consistent Uses: None.

Retention and Disposal Standards: Retained a minimum of ten years, and then reviewed for possible transfer to Library and Archives Canada (excluding questionnaires, which may be destroyed after two years).

RDA Number: 2015/022

Related Record Number: HC SUA 005

TBS Registration: 004095

Bank Number: HC PPU 038


Outreach Activities Related to Tobacco and Vaping Products

Description: This bank describes information that is related to individuals who participate in Health Canada sponsored outreach activities related to tobacco and vaping product use and tobacco and vaping product regulations. Activities may involve consultations through various means, including hard-copy correspondence, e-mail, or the use of social media sites including wikis, blogs, and other collaborative Internet technologies that are used or hosted by the institution; contests, competitions, and success stories; and may involve the need for license agreements. In some cases, consultations will be recorded. The personal information may include name, contact information, biographical information, date of birth, date of death, medical information, activities related to tobacco and vaping products, photographs, and views and opinions of or about tobacco and vaping products.

Note: In addition to the requirements specified on the Treasury Board of Canada Secretariat Personal Information Request form, individuals requesting information described by this bank must provide the title and date of the outreach activity, wherever possible.

Class of Individuals: General public, representatives of the academic and medical community.

Purpose: The personal information is used to fulfill Health Canada outreach activities related to tobacco and vaping product use and tobacco and vaping product regulations. Personal information is collected pursuant to Tobacco Act and Tobacco Products Information Regulations and Tobacco Products Labelling Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: program evaluation and Other: with notification, the proceedings of some tobacco and vaping outreach activities that are recorded may be made publicly available, including on the Internet. With consent, the contact information may be used to establish mailing lists to inform participants of future events, to contact individuals to seek views on issues of mutual interest.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC SUA 005

TBS Registration: 20110498

Bank Number: HC PPU 410


Tobacco Labelling Licenses Agreements, Authorization and Consent Forms

Description: This bank describes information that is related to individuals who have signed license agreements, authorization and consent forms allowing Health Canada to use their photograph, tobacco related illness and story on its health warning messages or health information messages displayed on tobacco product packages or used in tobacco related outreach activities (e.g., such as announcements, upcoming social marketing campaign and public opinion research). The personal information may include name, contact information, biographical information, date of birth, date of death, financial information, medical information, activities related to tobacco, photographs, and opinions and views of, or about, tobacco.

Class of Individuals: General public, individuals who sign an authorization form or licence agreement with Health Canada.

Purpose: The personal information is used to ensure licensing rights and consent to display messages on tobacco product packaging and outreach activities that inform individuals of the health risks associated with using tobacco products. Personal information is collected pursuant to Tobacco Act, Tobacco Products Information Regulations and Tobacco Products Labelling Regulations.

Consistent Uses: The information may be used or disclosed for the following purposes: contact information may be used to contact individuals who have provided testimonials to participate in departmental activities related to tobacco (e.g. announcements). With consent first name, medical information, photographs, opinions or views of, or about, tobacco may be used for anti-tobacco related promotional materials and activities.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Record Number: HC SUA 005

TBS Registration: 20110544

Bank Number: HC PPU 305


Tobacco and Vaping Product Research

Description: This bank describes information that is about individuals who have participated in research concerning the health impact of tobacco and vaping products. The personal information may include contact information, date of birth, educational information, sex, financial information, medical information, name, other identification numbers, physical attributes, personal views or opinions, personal product use, dietary information, human biological materials and signature.

Note: In addition to the requirements specified on the Personal Information Request form, individuals requesting information described by this bank must provide the name, date and location of the research in which they participated.
Pending TBS approval.

Class of Individuals: General Public, individuals who volunteer or who are solicited to participate in a particular research.

Purpose: The personal information is used to determine the effects of tobacco and vaping products on individuals. Personal information is collected pursuant to the Tobacco and Vaping Products Act (1997) and the Department of Health Act (1996).

Consistent Uses: The information may be used or disclosed for research, statistical, and health surveillance purposes. Personal information may be disclosed to contracted third parties to analyze human biological materials.

PIA: No PPIA or PIA has been developed prior to the development of the PIB given that tobacco research activities were in place prior 2010.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Records Number: HC SUA 005

TBS Registration Number: 20200009

Bank Number: HC PPU 432


Tobacco and Vaping Products Compliance, Monitoring and Enforcement

Description: This bank describes personal information that is used in support of compliance monitoring and enforcement activities related to the manufacture, sale, labelling and promotion of tobacco products and vaping products as set out in the Tobacco and Vaping Products Act. Potential non-compliance may be identified by consumer and public complaints, industry complaints or observations on social media channels. The personal information may include name, language preference, contact information, views, opinions, experiences of complaints. Personal information associated with inspections, compliance monitoring includes: name, language preference and contact information. In addition, if a contravention is issued under the authority of the Contraventions Act, the outcome of any prosecution process which results from the issuance of said contravention will also be documented.

Class of Individuals: General public, complainants such as industry employees (e.g., manufacturers, retailers, distributors).

Purpose: The personal information will be used to support compliance and enforcement activities, including inspections and investigations related to tobacco and vaping products. The personal information is collected pursuant to Part V (Sections 34-38) of the Tobacco and Vaping Products Act.

Consistent Uses: Personal information collected during inspections (on-site and online) and investigations may be shared with local judiciary for approval of search warrants, law enforcement agencies for execution of search warrants and with the Department of Justice, Public Prosecution Services of Canada (Prosecution and Related Criminal Matters JUS PPU 015) for the purpose of prosecution of criminal offences under the Tobacco and Vaping Products Act. The information may also be used for reporting to senior management, inform policy development, for audit and evaluation.

Retention and Disposal Standards: Under development.

RDA Number: 2015/022

Related Class of Record Number: HC SUA 005

TBS Registration: 20210003

Bank Number: HC PPU 433

Water Quality

The objective of the Water Quality Program is to help manage potential risks to the health of Canadians associated with water quality. Specifically, the Program works with other federal government departments and agencies, provinces and territories, under the authority of Section 55 of the Canadian Environmental Protection Act (CEPA) 1999, to establish the Guidelines for Canadian Drinking Water Quality (GCDWQ). These guidelines are endorsed through a federal, provincial and territorial (FPT) collaborative process, and are used by all FPT jurisdictions in Canada as the basis for establishing their drinking water quality requirements. In the delivery of this program, key activities include the development and dissemination of drinking water quality guidelines, guidance documents, emergency screening values (developed upon request), strategies and other tools. The program also works with standard-setting organizations to develop health-based standards for materials that come into contact with drinking water, and has forged longstanding partnerships with international agencies, including the World Health Organization and the U.S. Environmental Protection Agency. The Program contributes to Health Canada's Health Protection and Promotion Core Responsibility.

Safe Environments - Water Quality

Description: Includes records related to water quality and potential health effects associated with specific drinking water contaminants; scientific studies and summaries regarding health effects, exposure, and treatment of water contaminants; guidelines for drinking water quality (Guidelines for Canadian Drinking Water Quality), recreational water quality (Guidelines for Canadian Recreational Water Quality) and grey water re-use (Canadian Guidelines for Domestic Reclaimed Water for Use in Toilet and Urinal Flushing); plain language summaries of certain final guidelines for drinking water quality federal guidance on meeting drinking water guidelines; documents associated with the Federal-Provincial-Territorial Committee on Drinking Water and development of national and international standards related to water quality.

Document Types: health risk assessments, exposure and monitoring information, research proposals, reports and summaries, correspondence, presentations, contracts with collaborators, strategic policy advice, fact sheets, questionnaires, briefing notes, committee agendas, minutes, and technical documents.

Record Number: HC ERH 025

Workplace Hazardous Products

The program objective is to ensure that suppliers provide critical health and safety information on hazardous chemicals to workers, the target population for the program. It therefore helps Canadian workers who come into contact with workplace chemicals have the information they need to protect themselves. The program supports the comprehensibility and accessibility of labels and data sheets for hazardous products, oversees the process for exempting confidential business information, and supports consistent compliance and enforcement by the Labour program at Employment and Social Development Canada, and the provinces and territories. It does not administer the requirements for occupational health and safety. Through the implementation of the Globally Harmonized System of Classification and Labelling of Chemicals, openness and transparency is strengthened as modernization of health protection legislation, regulation and delivery continues. The program operates under the authorities of the Hazardous Products Act and the Hazardous Materials Information Review Act, and contributes to Health Canada's Core Responsibility of Health Protection and Promotion.

WHIMS Confidential Business Information

Description: Includes records related to the hazard assessment and validity of claims for exemption from the disclosure of Confidential Business Information.

Document Types: applications for claims for exemption, health and safety hazard assessments and evaluations, toxicological studies, Safety Data Sheets, Statements of Decisions and Orders including Compliance Undertakings, product formulations, attestation forms, substantiating information and correspondence.

Record Number: HC WCS 001

Monitoring of Workplace Hazardous Materials

Description: Includes records related to the Workplace Hazardous Materials Information System (WHMIS) committees, legislation, regulations/amendments, policy development, stakeholder engagement.

Document Types: Memoranda, Regulatory Impact Analysis Statement (RIAS), comments on regulations, minutes, ministerial dockets, Treasury Board submissions.

Record Number: HC WCS 002

Internal Services

Internal Services are groups of related activities and resources that are administered to support the needs of programs and other corporate obligations of an organization. These groups are: Acquisitions; Communications Services; Financial Management; Human Resources Management; Information Management; Information Technology; Legal Services; Management and Oversight Services; Materiel; Real Property; Travel and Other Administrative Services. Internal Services include only those activities and resources that apply across an organization and not to those provided specifically to a program.

Acquisitions

Acquisition Services involve activities undertaken to acquire a good or service to fulfil a properly completed request (including a complete and accurate definition of requirements and certification that funds are available) until entering into or amending a contract.

Communications Services

Communications Services involve activities undertaken to ensure that Government of Canada communications are effectively managed, well coordinated and responsive to the diverse information needs of the public. The communications management function ensures that the public - internal or external - receives government information, and that the views and concerns of the public are taken into account in the planning, management and evaluation of policies, programs, services and initiatives.

Financial Management

Financial Management Services involve activities undertaken to ensure the prudent use of public resources, including planning, budgeting, accounting, reporting, control and oversight, analysis, decision support and advice, and financial systems.

Human Resources Management

Human Resources Management Services involve activities undertaken for determining strategic direction, allocating resources among services and processes, as well as activities relating to analyzing exposure to risk and determining appropriate countermeasures. They ensure that the service operations and programs of the federal government comply with applicable laws, regulations, policies, and/or plans.

Information Management

Information Management Services involve activities undertaken to achieve efficient and effective information management to support program and service delivery; foster informed decision making; facilitate accountability, transparency, and collaboration; and preserve and ensure access to information and records for the benefit of present and future generations.

Information Technology

Information Technology Services involve activities undertaken to achieve efficient and effective use of information technology to support government priorities and program delivery, to increase productivity, and to enhance services to the public.

Legal services

Legal services involve activities undertaken to enable government departments and agencies to pursue policy, program and service delivery priorities and objectives within a legally sound framework.

Management and Oversight Services

Management and Oversight Services involve activities undertaken for determining strategic direction, and allocating resources among services and processes, as well as those activities related to analyzing exposure to risk and determining appropriate countermeasures. They ensure that the service operations and programs of the federal government comply with applicable laws, regulations, policies, and/or plans.

Materiel

Materiel Services involve activities undertaken to ensure that materiel can be managed by departments in a sustainable and financially responsible manner that supports the cost-effective and efficient delivery of government programs.

Travel and Other Administrative Services

Travel and Other Administrative Services include Government of Canada travel services, as well as those other internal services that do not smoothly fit with any of the internal services categories.

Classes of Personal Information

Clinical Trials

This is a class of personal information collected by or provided to departmental officials who review clinical trials in connection to Health Products, Food Safety and Nutrition, Environmental Risks to Health, Substance Abuse, Radiation Protection and Pesticide Safety, and other topics related to the mandate and mission of Health Canada. Retrievable records consist of data gathering instruments, including questionnaires that may contain personal information and de-identified data sets. Individuals seeking access to these records must provide the title of the research project in which they participated, the location and date, and any other data that may help to identify and locate the personal information they are seeking. The retention periods for these research projects are controlled by the record schedules of the subject area that is responsible for the activity.

Health Related Research

This is a class of personal information collected by or provided to departmental officials who facilitate research and perform statistical analysis in connection to Health Products, Food Safety and Nutrition, Environmental Risks to Health, Substance Abuse, Radiation Protection and Pesticide Safety and other topics related to the mandate and mission of Health Canada. Retrievable records consist of data gathering instruments, including questionnaires that may contain personal information and de-identified data sets. Individuals seeking access to these records must provide the title of the research project in which they participated, the location and date, and any other data that may help to identify and locate the personal information they are seeking. The retention periods for these research projects are controlled by the record schedules of the subject area that is responsible for the activity.

Subject Files

In the course of conducting the programs and activities of Health Canada, personal information may be accumulated that is not described by any specific information bank described in this Chapter. This personal information exists in a fragmented form throughout the subject files of the department. This form of information is retrievable only if specifics are provided concerning the details of the subject matter and related departmental activity, as well as the region responsible for the activity and timeframe in which it took place. The personal information contained in the subject files is retained for the same period of time as the related subject information and disposed of according to the appropriate record schedules.

Transfer Payment Programs for Organizations

This class of personal information describes personal information that is used in support of transfer payment programs for organizations other than sole proprietorships and general partnerships. Personal information on organization representatives is not collected for administrative purposes at any time during the processing of transfer payment applications or program administration. Personal information may be shared with other programs of the institution, with programs of other federal institutions and provincial and municipal governments and with other organizations in order to verify the stacking of grants and verify audit recipients, to administer the programs including sharing contact information between similar initiatives for networking and knowledge exchange purposes. Information on the programs may be found by organization name, by arrangement/project, and by year. Individuals seeking access to these records must provide the name of the transfer payment program for which their organization applied, the date and any other data that may help to identify and locate the personal information they are seeking. Retention and disposal standards may vary from one program to another and are subject to approval by Library and Archives Canada.

Manuals

  • A Curriculum for Training Family Home Visitors (Invest in Kids)
  • A Guide for the Evaluation Report March 2005
  • A Guide to Developing a Multi-Year Work Plan
  • A Guide to Green Government
  • Above Ground Diesel Storage & Distribution System
  • Above Ground Fuel Oil Storage and Distribution Systems, 4,000 Litres and Smaller Training Manual
  • Addition of Vitamins and Minerals to Foods, 2005
  • Additional Donor Exclusion Measures to Address the Potential Risk of Transmission of variant CJD through the blood supply
  • Advanced Treatment Centre
  • Advertising Standards Canada and Health Canada's Role and Consultation Related to Advertising Review and Complaint Adjudication
  • Alternate Sample Retention for Packaged Drugs
  • American Conference of Governmental Industrial Hygienists, Threshold Limit Values and Biological Exposure Indices
  • Analyse d'une évaluation quinquennale (available in French only)
  • Analytical Methods and Techniques for Colours in Foods
  • Analytical Methods for Pesticide Residues in Foods
  • Analytical Methods for the Regulatory Analysis of Foods
  • Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines - Selected Category IV Monograph Drugs
  • Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines-Drugs Used in Clinical Trials
  • Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule D Drugs (Biological Drugs)
  • Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule C Drugs
  • Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs
  • Annex to GMP Guidelines - GMP for Positron Emitting Radiopharmaceuticals
  • Annex to the GMP Guideline Schedule D drugs part II: Human Blood and Blood Components
  • Annex to the Good Manufacturing Practices Guidelines-Good Manufacturing Practices (GPM) for Positron Emitting Radiopharmaceuticals
  • Annex to the Good Manufacturing Practices Guidelines-Good Manufacturing Practices (GPM) for Positron Emitting Radiopharmaceuticals
  • Annex to the Natural Health Products (NHPs) Compliance and Enforcement Policy for Exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (UPLAR) (POL-0093)
  • Application for a Manufacturer's Certificate to Cover Export of Medical Devices
  • Application for Alternate Sample Retention
  • Approach to Special Review [DIR2014-01]
  • ASIST Trainers Manual Ed 1.6x
  • Assainissement et hygiène du milieu (available in French only)
  • Assessing the Development of a Health Plan
  • Assessment of GMP Compliance for Foreign Sites
  • Assessment of Mutagenicity Health Protection Branch Mutagenicity Guidelines (The)
  • Assessment of the Economic Benefits of Pesticides [DIR93-17]
  • BC Food Lab Standard Operating Procedures, Analytical Methods, Policies and Work Instructions
  • BC Food Laboratory Quality Manual
  • BC region Business Continuity Planning Manual
  • BC Region Drinking Water Safety Program Funding Guidelines 2011-12 (DRAFT)
  • BC region HIV Reportability Manual
  • BCCDC Communicable Disease Control Manuals - Chapter 1, 2, 3, 4 and 5
  • Benzene Guideline Technical Document: Guidelines for Canadian Drinking Water Quality
  • Blood donation and preparation of blood components (available in French only)
  • Blood Establishment Licence Amendment Requirements for Information Technology Submission
  • Blood Lead Intervention Levels and Strategies
  • Border Integrity Approach
  • Building Public Confidence in Pesticide Regulation and Improving Access to Pest Management Products Horizontal Initiative (BPC Initiative)
  • Bureau of Biologics and Radiopharmaceuticals, Guidance to Industry Product-Specific Facility information
  • Canada Labour Code, Part II, Occupational Health and Safety Regulations
  • Canadian Drinking Water Guidelines, Sixth Edition
  • Canadian Drug Identification Code
  • Canadian Environmental Protection Act Human Health Risk Assessment for Priority Substance
  • Canadian Guidelines for Domestic Reclaimed Water for Use in Toilet and Urinal Flushing
  • Canadian Label Improvement Program for Pesticides Used on Companion Animals [DIR2002-01]
  • Canadian Nutrient File Compilation of Canadian Food Composition Database Structure
  • Canadian recommendations for water
  • Canadian Self-Assessment
  • Canadian Tuberculosis Standards 6th Edition (2007)
  • Canadian Water Guidelines
  • Carcinogens and other chemicals in tobacco smoke
  • CEPA - Mental Illness and Addiction
  • CEPA - Chronic Diseases and Injuries
  • Chemical/Commodity/Pest-Based Strategy for Addressing Trade Irritants and Risk Reduction for Avocados [FR10-07-1009]
  • Chemical Pesticide Research Permit Guidelines [DIR98-05]
  • Chemigation [DIR93-13]
  • Chemistry Requirements for the Registration of a Manufacturing Concentrate or an End-Use Product Formulated from Registered Technical Grade of Active Ingredients or Integrated System Products [DIR98-03]
  • Chemistry Requirements for the Registration of a Technical Grade of Active Ingredient or an Integrated System Product [DIR98-04]
  • Chlorofluorocarbons in Pesticides Products [DIR93-11]
  • Chronic Disease and Injury Prevention RMAF
  • Classification of Beans on Labels and Research Requirements [DIR93-14]
  • Classification of Observations Made in the Conduct of Inspections of Clinical Trials
  • Cleaning Validation Guidelines
  • Collecte du sang et préparation des composés sanguins (available in French only)
  • Colour Standards for Seed Treatment Products and Labelling of Treated Seed [DIR94-06]
  • Communicating the Health Risks of Extreme Heat Events: Toolkit for Public Health and Emergency Management Officials
  • Community Based Drinking Water Quality Monitors Manual
  • Community Based Water Monitor Water Trax Data Base Training Manual
  • Compendium des méthodes d'analyse Vol. 3 - Techniques de laboratoire et analyse microbiologique des aliments (available in French only)
  • Compendium des méthodes d'analyse Vol. 4 - Détection des matières étrangères dans les aliments (available in French only)
  • Compendium of Analytical Methods
  • Compliance and Enforcement Policy
  • Compliance and Enforcement Strategy for the safety of cells tissues and organs intended for transplantation
  • Compliance Policy [DIR2007-02]
  • Compliance Verification Involving Blood and Blood Components
  • Compliance Verification Involving Clinical Trials
  • Compliance Verification involving Human Cells and Tissues and Organs for Transplantation
  • Compliance Verification of Incidents Involving the Possible Transmission of an Infectious Agent through Processing and Distribution of Semen for Assisted Conception
  • Compliance Verifications and Investigations Relating to the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use
  • Comprehensive Data Summaries [DIR97-01]
  • Conditions for provision of packaging-labelling services for drugs under foreign ownership
  • Conducting Blood Establishment Inspections
  • Conducting Cells and Tissues and Organs Establishments Inspections
  • Confidential Business Information Designation and Segregation Part 1: Submission of Test Data [DIR2006-03]
  • Confidential Business Information Designation and Segregation Part 2: Previously Provided Test Data [DIR2006-04]
  • Consolidated Contribution Agreement Template
  • Consumer Advertising Guidelines for Marketed Health Products (for non-prescription drugs and natural health products)
  • Consumer Drug Advertising
  • Containment Standards for Veterinary Facilities
  • Contribution Agreement Guide
  • Contribution Funding Framework Overview
  • Contribution Funding Framework User Manual
  • Co-operative Re-evaluation/Re-registration of the Heavy Duty Wood Preservatives (HDWP) Pentachlorophenol, Creosote and Chromated Copper Arsenate (CCA) [JR06-94-1008]
  • Coordination of Regulatory Review and Re-evaluation [JR05-98-0909]
  • Course Manual - Special Care Facility Emergency Planning
  • CPS Compendium of Pharmaceuticals and Specialties (current edition 2011)
  • Déclaration sur le mal des transports (RMTC 1996; 22 : 101-111) (available in French only)
  • Designing Marketplace Labels of Domestic Class Pest Control Products [LPS2011-03]
  • Developing and Implementing a Health Plan
  • Development of Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media [RC12-06-0808]
  • Diagnostic x-ray equipment compliance and facility survey
  • Direction for Use of Estrogen-Progestin Combination Oral Contraceptives (OCs)
  • Directive 99-01: Donor Exclusion to Address Theoretical Risk of Transmission of Variant CJD through the Blood Supply
  • Directive D2000-01 - Donor Exclusion to Address Theoretical Risk of Transmission of Variant CJD through the Blood Supply
  • Directive 101-Funding Approaches
  • Directive 102-Funding Arrangement Management
  • Directive 103-Notice of Budget Adjustments (NOBA)
  • Directive 104-Text Deviation (formerly Change Request)
  • Directive 105-Pre-Arrangement and Pre-Fiscal Year Expenses
  • Directive 121-Financial Reporting
  • Directive 123-Reporting Management
  • Directive: Implementation of Pre-storage Leukoreduction of Cellular Blood Components
  • Directives d'exploitation et entretien d'établissements : Établissement exploité par Santé Canada - Guide de contribution au plan d'immobilisations à long terme (available in French only)
  • Directives relatives aux monographies de produit et aux prospectus de conditionnement des drogues de l'annexe (available in French only)
  • Discount cigarettes
  • Disinfectants: Preparation of Application for Drug Identification Number
  • Disposal Statements for Control Product Labels [DIR99-04]
  • Drug Analysis Service Quality Manual
  • Drug Distribution Manual
  • Drug Identification Number (DIN) Enforcement Policy
  • Drug Treatment Funding Program Results-Based management Accountability Framework
  • Efficacy Data for Antimicrobial Products [T-1-215]
  • Efficacy Guidelines for Plant Protection Products [DIR2003-04]
  • eHealth Future Evaluation Framework: 2013-18
  • Electronic Service Delivery Reporting Tool (eSDRT)
  • Emergency Lodging Manual
  • Emergency Preparedness Plan
  • Environment (CCME), 1992
  • Environmental Contaminants Manual
  • Environment Label Claims and Advertising of Pest Control Products [DIR96-02]
  • Establishment Licensing registration process for cells tissues and organs for transplantation
  • Establishment Licensing registration renewal process for cells tissues and organs for transplantation
  • Estimating Percent Crop Treated and Projected Percent of Crop Treated for Pesticides [RC18-07-0808]
  • Expansion, Development and Harmonization of Crop Groupings with Specified Representative Crops for Field Crop Residue Studies [FR09-06-0909]
  • Exposure Guidelines for Residential Indoor Air Quality
  • Fabrication et vérification des anticorps monoclonaux et de leurs conjugués (available in French only)
  • Facility Operations and Maintenance Guidelines: Health Canada Operated Facility Guide to Providing Input to the Long-Term Capital Plan
  • Fiches maîtresses des produits (available in French only)
  • First Aid Labelling Statements [DIR2007-01]
  • Food Directorate Interim Policy on Foods from Cloned Animals
  • Food Retail and Food Services Code (Canadian Food Inspection System)
  • Formulants Policy and Implementation Guidance Document [DIR2006-02]
  • Framework for Research on Active Living
  • Fungal contamination in public buildings: A guide to recognition and management
  • General principles for labelling and advertising claims that relate to the nutrition recommendations
  • GMP for Medical Gases
  • GMP Inspection of Drug Establishments
  • GMP Inspection Policy for Canadian Drug Establishments
  • Good Clinical Practice: Consolidated Guideline ICH Topic E6
  • Good Laboratory Practice [DIR98-01]
  • Good Manufacturing Practices
  • Good Manufacturing Practices - GNP Guideline 2009 v.2 GUI-0001
  • Good Manufacturing Practices (GMP) and Establishment Licensing Enforcement Directive
  • Good Manufacturing Practices (GMP) Guidelines - 2009 Edition
  • Good Manufacturing Practices (GMPs) for Infant Formula
  • Grille régionale d'élaboration et d'évaluation du plan de santé (available in French only)
  • Guidance Document - The Use of Probiotic Microorganisms in Food
  • Guidance Document for Mandatory Problem Reporting for Medical Devices
  • Guidance Document for Preparing a Submission for Food Health Claims
  • Guidance Document on the Application for a Certificate of a Pharmaceutical Product
  • Guidance Document: Cells Tissues and Organs (CTO) for Transplantation
  • Guidance Document: Factors Considered in the Assessment of Risks Involved in the Use of Positron Emitting Radiopharmaceuticals in Basic Research Involving Humans
  • Guidance Document For the Sales Information Reporting Regulations and Reporting Forms
  • Guidance for Designing Peel-Back and Multi-Component Labels of Domestic Class Pest Control Products [LPS2011-04]
  • Guidance for Evaluating Human Health Impacts in Environmental Assessment: Drinking and Recreational Water Quality
  • Guidance for Evaluating Human Health Impacts in Environmental Assessment: Noise
  • Guidance for Evaluating the Acceptability of Environmental Fate Studies Conducted on Foreign Soils (also referred to as the NAFTA/International Soils X-Walk) [RC13-06-0808]
  • Guidance For Pre-Manufacturing And Pre-Exportation Notifications Under Canada's Access To Medicines Regime (C.07.011)
  • Guidance for Records Related to Clinical Trials
  • Guidance on Controlling Corrosion in Drinking Water Distribution Systems
  • Guidance on Donor Semen Special Access Programme: Alternative Test Requirements
  • Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access
  • Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees
  • Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites
  • Guidance on Investigation of Reported Medical Device Problems
  • Guidance on Medical Device Compliance and Enforcement
  • Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees
  • Guidance on Risk Classification of Medical Device Observations
  • Guidance on the Manufacture of Human Plasma-Derived Products, Viral Safety Evaluation
  • Guidance on the Medical Device Inspection Program
  • Guidance on the Processing and Distribution of Semen for Assisted Conception Regulations
  • Guidance on the risk classification of observations to semen establishments
  • Guidance Policy: Use of Positron Emitting Radiopharmaceuticals in Basic Research Involving Humans
  • Guidance to Improve Statements on Labels of Domestic Class Pest Control Products [LPS2011-02]
  • Guide des exigences canadiennes relatives aux tentes pour l'industrie (available in French only)
  • Guide d'évaluation de projet : une démarche participative - Source : Section des fonds pour la santé de la population 2001 (available in French only)
  • Guide du requérant (available in French only)
  • Guide for Radon measurements in residential dwellings
  • Guide for the labelling of drugs for veterinary use
  • Guide on Recalls of Medical Devices
  • Guide to Community Health Planning
  • Guide to Developing Accurate Nutrient Values
  • Guide to Developing an Operations and Maintenance Management Plan
  • Guide to Good Asset Management Practices
  • Guide to Project Evaluation
  • Guide to Project Evaluation: A Participatory Approach - Source: Population Health Funds 2001
  • Guide, Home and Community Care Essential Service Elements Risk Management Appraisal Tool, July 2008
  • Guideline Concerning the Safety and Physiological Effects of Novel Fibre Sources and Food Products Containing Them
  • Guidelines for Canadian Drinking Water Quality, Sixth Edition
  • Guidelines for Canadian Drinking Water Quality: Guideline Technical Document - 2-Methyl-4-chlorophenoxyacetic Acid (MCPA)
  • Guidelines for Canadian Recreational Water Quality
  • Guidelines for Determining Environmental Chemistry and Fate of Pesticides [T-1-255]
  • Guidelines for Developing a Toxicological Database for Chemical Pest Control Products [DIR2005-01]
  • Guidelines for Efficacy Assessment of Fungicides, Bactericides and Nematicides [DIR96-01]
  • Guidelines for Evaluation of Safety and Efficacy of Antimastitis Intramammary Infusion Drugs
  • Guidelines for Evaluation of Safety and Efficacy of Teat Dip Formulations
  • Guidelines for health information programs involving the sale of foods
  • Guidelines for incidental additive submissions
  • Guidelines for Infection Control
  • Guidelines for raw ground beef products found positive for Escherichia coli O157:H7
  • Guidelines for Reliance on Proprietary Data Under the Pest Control Products Regulations [DIR2010-04]
  • Guidelines for Temperature Control of Drug Products during Storage and Transportation
  • Guidelines for the Development of Efficacy Data to Support the Use of Animal Drugs in Feeds
  • Guidelines for the nomenclature and classification of externally visible defects in metal containers of canned foods
  • Guidelines for the Nomination of Substances to the Revised In-Commerce List
  • Guidelines for the Preparation of Toxicity and Residue Submissions for the Human Safety of Veterinary Products Intended for Use in Food Producing Animals
  • Guidelines for the Production, Distribution, Retailing and Use of Refrigerated Pre-packaged Foods with Extended Shelf Life
  • Guidelines for the Registration of Microbial Pest Control Agents and Products [DIR2001-02]
  • Guidelines for the Registration of Non-Conventional Pest Control Product [DIR2012-01]
  • Guidelines for the Safety Assessment of Novel Foods
  • Guidelines on nutrition labelling
  • Harmonization of environmental chemistry and fate data requirements for chemical pesticides under NAFTA [DIR2003-03]
  • Harmonization of Environmental Data Requirements under NAFTA for Registration of Chemical Pesticides [B97-02]
  • Harmonization of Guidance for Terrestrial Field Studies of Pesticide Dissipation under the North American Free Trade Agreement [DIR2006-01]
  • Health Canada Directive: Technical Requirements For Therapeutic Donor Insemination
  • Health Canada Evaluation Policy
  • Health Canada Facility Condition Reporting: Terms of Reference
  • Health Canada PMRA/Pesticide Compliance Program Inspector's Field Operating Manual
  • Health Canada Standard Operating Procedures (SOP) for Grants and Contributions
  • Health Canada Standards for Developing Potable Water Management Plans
  • Health Canada's Action Plan in Response to Stakeholder Feedback from Consultations on Modernizing Canada's Framework for Health Claims on Food
  • Health Infostructure Strategic Action Plan (HSIAP) March 2012
  • Health Planning and Implementation Summary Chart
  • Health Product and Food Branch Review of Regulated Products: Policy and Guidance on Public Input
  • Health Services Integration Fund Implementation Guide
  • Health Services Integration Fund Tool Kit (HSIF)
  • Health-Based Tolerable Daily Intake / Concentrations and Tumorigenic Dose / Concentration for Priority Substances
  • Housing an Aging Population: Guidelines for Development and Design
  • How Health Canada Contributes to Environmental Assessment
  • How to apply the Product Category Priority Approach for NHPs
  • How to apply the Risk-Based Approach for NHPs
  • How to Conduct an eHealth Readiness Assessment April 2013
  • How to Handle a Drug Product Compliance Verification
  • How to Use the Incident System
  • HPFB Inspectorate Business Continuity Plan Activation Plan de continuité des opérations
  • HPFB Inspectorate Emergency Response Plan
  • HPFBI - Recall Policy
  • HPFBI Drug Recall Procedure
  • HPFBI Medical Device Recall Procedure
  • Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS)
  • Human Plasma Collected by Plasmapheresis
  • Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations
  • Implementation of the Globally Harmonized System of Classifications and Labeling of Chemicals (GHS) [JR03-03-0809]
  • Import Requirements for Health Products under the Food and Drugs Act and its Regulations
  • Importation for Manufacturing and Export Program (IMEP) [DIR95-05]
  • Increasing Adoption of Biopesticides [RR08-04-0909]
  • Infection Control Guideline: An Integrated Protocol to Manage Health Care Workers Exposed to Blood borne Pathogens
  • Infection Control Guideline: Foot Care by Health Care Providers
  • Infection Control Guideline: Guidelines for Preventing the Transmission of Tuberculosis in Canadian Health Care Facilities and Other Institutional Settings
  • Infection Control Guideline: Hand Washing, Cleaning, Disinfection and Sterilization in Health Care
  • Infection Control Guideline: Infection Prevention and Control Practices for Personal Services: Tattooing, Ear/Body Piercing, and Electrolysis
  • Infection Control Guideline: Occupational Health In Health Care
  • Infection Control Guideline: Preventing the Spread of Vancomycin-Resistant Enterococci (VRE) in Canada
  • Infection Control Guideline: Preventing the Transmission of Bloodborne Pathogens in Health care and Public Services Settings
  • Infection Control Guideline: Proceedings of the Consensus Conference on Infected Health Care Workers - Risk for Transmission of Bloodborne Pathogens
  • Infection Control Guideline: Routine Practices and additional Precautions for Preventing the Transmission of Infection in Health Care
  • Initial Product/Private Label Registration Process [DIR93-21]
  • Inspection des installations et de l'équipement de radiodiagnostic (Available in French Only)
  • Inspection of Clinical Trials Involving Human Subjects
  • Inspection of Establishments that Process and-or Distribute and-or Import Donor Semen for Use in Assisted Conception
  • Inspection of Medical Device Manufacturers Importers and Distributors
  • Inspection Procedures for Food Plant Inspectors
  • Inspection Strategy for Blood and Source Plasma Establishments
  • Inspection Strategy for Canada's Access to Medicines Regime
  • Inspection Strategy for Clinical Trials
  • Inspection Strategy for Medical Device Companies
  • Inspection Strategy for Post-Market Surveillance
  • Inspection Strategy For Semen Establishments
  • Interim guidelines for the control of verotoxinogenic escherichia coli including E. Colio157:h7 in ready to eat fermented sausages containing beef or a beef product as an ingredient
  • Internal Requests for Evidence of GMP Compliance for Domestic and Foreign Sites
  • Issuance of Drug Establishment Licences
  • Issuance of GMP Compliance Certificate under the scope of Mutual Recognition Agreement (MRA)
  • Knowledge in a Book (Module 5)
  • Label Improvements for Spot-on Pesticides Used for Flea and Tick Control on Companion Animals [DIR2010-02]
  • Label Process Changes Part 1: Overview [LPS2003-01]
  • Label Process Changes Part 2: Guidance for Industry [LPS2003-02]
  • Laboratory Biosafety Guidelines
  • L'évaluation du risque à la santé humaine des substances d'intérêt prioritaire (available in French only)
  • Lignes directrices concernant l'exercice de la médecine des voyages - (RMTC 1999; 25 : 1-3) (available in French only)
  • Liste des médicaments (available in French only)
  • Low-Acid and Acidified Low-Acid Foods In Hermetically Sealed Containers
  • L'utilisation des opioïdes dans le traitement de la dépendance aux opioïdes (available in French only)
  • Management of a Site Reference File
  • Management of Emergency Delivery
  • Managing Health Risk Associated with the Consumption of Unpasteurized Fruit Juice/Cider Products
  • Managing Inspections conducted by Foreign Regulatory Authorities at Canadian Sites
  • Manuel de la santé des fonctionnaires fédéraux pour les agents en hygiène de l'environnement (available in French only)
  • Manuel de la tuberculose (available in French only)
  • Manuel qualité du Service d'analyse des drogues
  • Manufacturing and Compounding Drug Products in Canada
  • Master Product/Master Copy Registration Process [DIR93-20]
  • MedEffect Side Effects Booklet
  • Mini size cigarettes
  • Minor Use Joint Review Procedures [JR04-04-0809]
  • Model Labels for Pool and Spa Products Not Eligible for Scheduling [DIR93-06]
  • Modeling Pesticide Transport to Groundwater [RC11-05-0809 & 0909]
  • MRA Equivalency Evaluation of a Regulatory Authority's GMP Compliance Programme
  • Mutual Recognition Agreement (MRA) Evaluation Framework for determining the equivalency of Good Manufacturing Practices (GMP) Compliance Programmes
  • Natural Health Products Compliance and Enforcement Policy
  • Notice: Lot Release Program for Schedule D (Biologic) Drugs
  • Notice: New Draft Quality Guidance on the Implementation of the Common Technical Document for Biological Products
  • Notification By Health Canada to Foreign Regulatory Authorities of Inspections of Drug Establishments under their Jurisdiction
  • Occupational Health Assessment Guide
  • Official Methods for the Microbiological Analysis of Foods
  • Operational Guidelines for Environmental Health Officer's
  • Oral Health Protocols
  • Orientation Manual, HCCP
  • Organizing and Formatting a Complete Submission for Pest Control Products [DIR2003-01]
  • Own-Use Import Task Force Report
  • Personal Services: Psychosocial Planning for Disasters
  • Pesticide Export Guidelines [DIR95-06]
  • Pesticide Labelling Framework [LPS2011-01]
  • Pesticide Resistance Management Labelling Based on Target Site/Mode of Action [DIR2013-04]
  • Pesticides for Aquatic Applications [DIR93-12]
  • Pesticides for Use in Forest and Woodlands Management [DIR93-10]
  • PIC-S Annex 11: Computerized systems
  • Plant Growth Regulators [DIR93-09]
  • Plasmid Biology and Recombinant DNA Methodology
  • PMRA Re-evaluation Program [DIR2001-03]
  • Policy & Guidelines on Strategic Environmental Assessment
  • Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use
  • Policy Guide for the Management of Advisory Committees in Health Canada
  • Policy on Counterfeit Health Products
  • Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011)
  • Policy on Managing Health Risk Associated with the Consumption of Sprouted Seeds and Beans
  • Policy on Specified Risk Material (SRM) in the Food Supply
  • Post-Market Reporting Compliance - Drug Inspection - Ébauche de documents portant sur le Programme d'inspection liée à la conformité aux exigences de déclaration après commercialisation
  • Post-Market Reporting Compliance- Process for Establishments Found Non-Compliant
  • Potable Water Regulations for Common Carriers
  • Pre-Exportation Drug Inspection
  • Pre-Harvest Intervals for Grazing and Cutting for Hay of Immature Crops Treated with Pesticides [DIR93-18]
  • Preparation of Human New Drug Submissions
  • Preparation of Veterinary New Drug Submissions
  • Preparing and Handling Powdered Infant Formula
  • Preparing for and Responding to Workplace Trauma: A Manager's Handbook
  • Prioritization of Drug Compliance Verification and Investigation Incidents
  • Procedure for Handling MDEL Applications and Reapplications Which List Manufacturers of Class II III or IV Devices Who Do Not Hold Corresponding Device Licences
  • Process for Foreign Sites Assessed as Non-Compliant
  • Process for the request and reception of GMP Certificate of compliance from MRA countries
  • Process Parametric Release (PPR)
  • Process Validation : Terminal Sterilization Processes for Pharmaceutical Products
  • Process Validation: Aseptic Processes for Pharmaceuticals
  • Process Validation: Form-Fill Seal for Pharmaceuticals
  • Process Validation: Gaseous Sterilization for Pharmaceuticals
  • Process Validation: Irradiation Sterilization for Pharmaceuticals
  • Process Validation: Moist Heat Sterilization for Pharmaceuticals
  • Product Master Files
  • Product Monographs
  • Product Recall Procedures
  • Program Compendium
  • Programme de financement des tribunaux de traitement de la toxicomanie : Cadre de gestion et de responsabilisation axé sur les résultats (available in French only)
  • Proposed Policy: Definition and Energy Value for Dietary Fibre
  • Protection of Proprietary Interests in Pesticide Data in Canada [DIR2007-03]
  • Public Service Health Manual for Environmental Health Officers
  • Quality Assurance Project Plan for Drinking Water On Board Aircraft
  • Rates and Labelling Requirements for Metered Pyrethrin Products [T-1-242]
  • Recherche clinique (Available in French Only)
  • Recommendations for the Preparation and Handling of Powdered Infant Formula (PIF)
  • Re-evaluation Program Cyclical Re-evaluation [DIR2012-02]
  • Registering a New Source of Technical Grade Active Ingredient Under the Protection of Proprietary Interests in Pesticide Data Policy [DIR2008-01]
  • Registration of Pesticides for Emergency Use [DIR2001-05]
  • Registration of Products Sold in Response to an Invitation to Tender [DIR93-19]
  • Registration Requirements for Adjuvant Products [DIR93-15]
  • Regulatory Requirements for Positron-Emitting Radiopharmaceuticals (PERs)
  • Regulatory Status of Electrical Devices Intended for the Control of Flying Insect Pests [DIR99-01]
  • Renewing a Drug Establishment Licence- Renouveler une licence d'établissement de produits pharmaceutiques
  • Requesting a Health Risk Assessment for Blood and Blood Components and Cells and Tissues and Organs and Donor Semen and Xenografts
  • Requesting Additional Information When GMP Related Risk Issue Is Identified for a Foreign Site
  • Requirements for Submitting Data Index, Documents and Forms [DIR2006-05]
  • Residential indoor air quality guideline - carbon monoxide
  • Residue Chemistry Guidelines [DIR98-02]
  • Responsabilités du CCPP et de Santé Canada en matière d'examen de la publicité et consultations réciproques à ce sujet (available in French only)
  • Results-Based Management and Accountability Framework (RMAF)
  • Results-based Management and Accountability Framework: National Anti-Drug Strategy
  • Review and Approval of Inspection Reports
  • Review of Inspection Ratings
  • Review of Medical Device Inspection Ratings-Revision des Cotes d'inspection d'instrument medical
  • Revised Management of Submissions Policy [DIR2013-01]
  • Revisions to the Residue Chemistry Crop Field Trial Requirements [DIR2010-05]
  • Risk classification of GMP observations
  • Risk Classification of Observations Made During Inspection of Blood Establishments
  • Risk Classification of Post-Market Reporting Compliance Observations
  • SafeTALK Trainers Manual
  • Safety Code 27. Requirements for Industrial X-ray Equipment Use and Installation
  • Safety Code 30. Radiation Protection in Dentistry. Recommended Safety Procedures for the Use of Dental X-Ray Equipment
  • Sanitation Code for Canada's Food Service Industry
  • Scheduling of Selected Pool and Spa Chemicals [DIR93-05]
  • Security Assessments of Licensed Dealers for the Storage of Controlled Substances
  • Seizure Policy
  • Services de transfusion d'urgence (available in French only)
  • Ship Sanitation Manual
  • Smokeless Tobacco Products - A Chemical and Toxicity Analysis
  • Solvent Addictions Committee/Reference Manual and Best Practices Guidelines
  • Standard for the Fabrication Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices Version 2
  • Submission of Pharmacogenomic Information
  • Technical Requirements for Therapeutic Donor Insemination
  • Technical Requirements to Address the Safety of Cells, Tissues and Organs for Transplantation (Directive) and Safety Requirements for Human Cells, Tissues and Organs for Transplantation (Guidance Document)
  • The Committee to Advise on Tropical Medicine and Travel (CATMAT)
  • The Compliance Verification of Medical Device Problem Reports
  • The CPNP Guidebook
  • The Evaluation of Mandatory Problem Reports for Medical Devices
  • The PMRA Initiative for Reduced-Risk Pesticides [DIR2002-02]
  • The Pest Management Regulatory Agency's Strategy for Implementing the Toxic Substances Management Policy (TSMP) [DIR99-03]
  • The Residential Indoor Air Quality Guidelines for Formaldehyde
  • Therapeutic Comparative Advertising: Directive and Guidance Document
  • TLVs and BEIs Booklet, Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices
  • Toxicological Evaluation
  • Transfer Payment Procedures Manual
  • Transportation of Dangerous Goods (Laboratory Manual)
  • Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research
  • Useful Information for Environmental Assessments
  • User Problem Reporting for Medical Devices
  • User Requested Minor Use Label Expansion (URMULE) [DIR2001-01]
  • User Requested Minor Use Registration (URMUR) [DIR99-05]
  • Utilization of Continuous Cell Lines in the Manufacture of Biologics
  • Validation Documentation Requirements
  • Validation Guidelines for Pharmaceutical Dosage Forms
  • Value Assessment of Pest Control Products [DIR2013-03]
  • Voluntary Pesticide Resistance-Management Labelling Based on Target Site/Mode of Action [DIR99-06]
  • When and How to Request and Monitor Import Alerts
  • WHPSP Protocol for Indoor Air Quality Investigation

Additional Information

The Government of Canada encourages the release of information through requests outside of the Access to Information and Privacy (ATIP) process. You may wish to consult Health Canada's completed Access to Information (ATI) summaries and open data (where applicable).

To make an informal request, contact:

Health Canada
General Inquiries
70 Colombine Driveway
Address Locator 0900C2
Ottawa, Ontario K1A 0K9

  • Telephone: 613-957-2991
  • Toll free: 1-866-225-0709
  • Facsimile: 613-941-5366
  • E-mail: Info@hc-sc.gc.ca
  • Internet: www.hc-sc.gc.ca

Health Canada conducts Privacy Impact Assessments (PIAs) to ensure that privacy implications will be appropriately identified, assessed and resolved before a new or substantially modified program or activity involving personal information is implemented. Summaries of completed PIAs are available https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/access-information-privacy/privacy.html

Please see the Introduction to this publication for information on formal access procedures under the provisions of the Access to Information Act and the Privacy Act. The following outlines how to make a formal ATIP request.

Access Buy On-Line services, or mail your letter or Access to Information Request Form (Access to Information Act) or Personal Information Request Form(Privacy Act), along with any necessary documents (such as consent or the $5.00 application fee for a request under the Access to Information Act) to the following address:

Director, Access to Information and Privacy Operations
Health Canada
Holland Cross Tower B,
1600 Scott Street
7th Floor, suite 700
Address locator: 3107A
Ottawa, Ontario
K1A 0K9

Reading Room

In accordance with the Access to Information Act and the Privacy Act, the applicant may wish to review material in person

Access to Information and Privacy Division
Holland Cross Tower B,
Room 707
1600 Scott Street
Ottawa, Ontario
K1A 0K9

General Questions

If you have general questions about this publication, please contact:

The Privacy Management Division
11 Holland Avenue
Room 513
Ottawa, ON
K1A 0K9

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