Guidance Document - Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act

  • Date Adopted: 2017/03/10
  • Effective Date: 2017/03/10
  • Revised: 2019/03/12

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification.Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Contents

1. Introduction

Confidential business information (CBI) may be included in a variety of regulatory documents that Health Canada requires companies to submit to support evaluation of the safety, efficacy and quality of a given therapeutic product. In certain situations, where publicly available information is not sufficient, access to information that may contain CBI can assist the work of health researchers and practitioners, contributing to improved patient safety and better health outcomes for Canadians.
This guidance document describes how Health Canada applies the authority to disclose CBI under paragraph 21.1(3)(c) of the Food and Drugs Act. This provision gives the Minister of Health discretionary authority to disclose CBI to eligible persons for the purpose of protecting or promoting human health or the safety of the public.

1.1 Policy objective

Health Canada's application of this authority will be guided by principles of administrative law which require that powers be exercised fairly, reasonably and in accordance with the powers duly conferred on the body exercising them.

1.2 Terminology

Confidential Business Information is defined as follows in the Food and Drugs Act:

"confidential business information", in respect of a person to whose business or affairs the information relates, means - subject to the regulations - business information:

  1. that is not publicly available,
  2. in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and
  3. that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors.

Person is defined in the Food and Drugs Act defines to mean an individual or an organization as defined in section 2 of the Criminal Code.

Therapeutic product is defined in the Food and Drugs Act to mean a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations.

1.3 Background

Under paragraph 21.1(3)(c), the Minister of Health has discretionary authority to disclose CBI to a person (individual or organization) who carries out functions relating to the protection or promotion of human health or the safety of the public for the purpose of protecting or promoting human health or the safety of the public. This discretionary authority was added to the Food and Drugs Act by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) and came into force in November 2014.

21.1(3) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to

  1. a government;
  2. a person from whom the Minister seeks advice; or
  3. a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

Vanessa's Law added a definition of CBI to the Food and Drugs Act. This definition codifies common law principles and is consistent with other domestic law. It sets out three conditions that must be met in order for information to be considered CBI.  See the full definition in section 1.2 of this guidance.

Vanessa's Law also added an authority to make regulations specifying the business information obtained under the Food and Drugs Act in relation to a therapeutic product authorization that is not CBI, or the circumstances in which it ceases to be CBI, and to authorize the disclosure of this information.  These regulations came into force in March 2019, following extensive consultations. The regulations specify that clinical information in drug submissions for human use and medical device applications cease to be CBI following the issuance of a final regulatory decision, and that the Minister may release this information.  Clinical information within the scope of these regulations ceases to be CBI following a final regulatory decision and is not available through the s.21.1(3)(c) authority.  Canadians are able to search, request and view clinical information on a publicly available web portal maintained by Health Canada.

2. Scope and Application

This guidance document describes how Health Canada administers the authority to disclose CBI under paragraph 21.1(3)(c) of the Food and Drugs Act.  The guidance includes principles, considerations and procedures that aim to ensure that this authority is exercised fairly, reasonably and in accordance with Health Canada's powers under the Food and Drugs Act.

The authority to disclose CBI under paragraph 21.1(3)(c) applies to CBI related to therapeutic products, including prescription and non-prescription drugs, vaccines, blood and blood products, radiopharmaceuticals, donor semen for assisted conception, gene and cell therapies, tissues, organs, disinfectants, and medical devices. It does not apply to CBI related to natural health products.

This guidance document does not apply to other authorities in the Food and Drugs Act, which permit Health Canada to disclose CBI when the Minister believes that a product may present a serious risk of injury to human health, to other governments, and persons from whom the Minister seeks advice. Information on these authorities can be found in, Amendments to the Food and Drugs Act 2014 -- Guide to New Authorities.

This guidance does not apply to the public release of clinical information that ceases to be CBI following Health Canada's final regulatory decision. Guidance on the public release of clinical information can be found here.

3. Principles and Considerations for Health Canada's Exercise of its Authority under Paragraph 21.1(3)(c) of the Food and Drugs Act

The following principles and considerations provide guidance on the exercise of the Minister of Health's discretionary authority under paragraph 21.1(3)(c) .

3.1 Principles

  1. Health Canada will be judicious in its exercise of this authority. The requirements of paragraph 21.1(3)(c) are broadly defined to permit the Minister to act in a variety of circumstances. In addition to considering whether or not the requirements of the Act would be fulfilled, a decision made under this authority should consider all relevant factors both for and against exercising the discretion to disclose CBI in the particular circumstances.
  2. Information disclosed under this authority should contribute to improving the health of Canadians. Requests for disclosure under this authority are expected to clearly define how the purpose relates to this objective and should include a formal plan to use the information to advance knowledge, including making results publicly available.
  3. Use of this authority should be necessary to achieve the purpose for which the information is requested. A decision on whether or not to disclose CBI will include consideration of whether or not all other possible sources of the information, including from the originator of the information, have been exhausted. Only information that is directly related to the purpose set out in the request should be considered for disclosure.
  4. CBI disclosed under this authority must be used only for non-commercial purposes relating to the protection or promotion of human health or the safety of the public. 
  5. Recipients of information disclosed under this authority may be required to maintain the confidentiality of specified CBI included in the disclosure package. In deciding whether or not to impose this requirement, Health Canada will assess on a case-by-case basis all relevant factors to determine which information, if any, should be subject to a confidentiality obligation.   
  6. Health Canada will respect the confidentiality arrangements that it has in place with regard to information obtained in confidence from another regulator.
  7. Personal information contained in records considered for disclosure will be protected in accordance with the Privacy Act and other applicable law
  8. Health Canada will maintain the integrity of its regulatory function and take into consideration the consequences of disclosure on its capacity to evaluate and regulate therapeutic products based on science and in the interest of the health of Canadians.

3.2 Considerations - Persons to whom CBI may be disclosed

Health Canada's decision regarding disclosure of CBI includes an assessment of whether the person to whom the CBI would be disclosed fulfills the Act's requirement that they be a person (individual or organization) who carries out functions relating to the protection or promotion of human health or the safety of the public.

Where disclosure of CBI has been requested by an individual, Health Canada expects that the principal requester would have qualifications in a health profession or health research and demonstrated expertise in the subject of the request.

Where disclosure of CBI has been requested by an organization, Health Canada expects that it would be a not-for-profit organization and that its mandate, as described in its articles of incorporation or other documentation, would include purposes relevant to the protection or promotion of human health or the safety of the public and the health or safety issue that is the subject of the request. In addition, it is expected that the designated representative of the organization identified in the request would have qualifications in a health profession or health research and demonstrated expertise in the topic of the research.

An assessment of the qualifications of a requester may include other considerations, including:

  • Relevance of the requester's qualifications to the purpose of the proposed disclosure. Requesters should have the necessary expertise to lead the proposed project. Projects requiring specialized technical expertise may involve collaborators.
  • Record of contribution to the protection and promotion of the health and safety of Canadians in an area relevant to the subject of the request. Publications and research projects related to health and safety issues other than the subject of the request may be taken into account in assessing a request.
  • Record of disseminating information to advance scientific knowledge for non-commercial purposes.

3.3 Considerations - Purpose of disclosure

Health Canada's decision regarding disclosure of CBI will also include an assessment of whether the disclosure would fulfill the Act's requirement that the "purpose of the disclosure is related to the protection or promotion of human health or the safety of the public."

To meet this requirement, CBI considered for disclosure should relate to a therapeutic product that is available to the public. Consequently, Health Canada expects that requests for disclosure will relate to CBI obtained in the course of its regulatory activities to evaluate and monitor the safety, efficacy and quality of therapeutic products for use in Canada.

Health Canada may also consider the following to assess the purpose of disclosure.

  • Demonstrated relevance of the proposed project to the purpose of protecting or promoting human health or the safety of the public. Evidence should be provided regarding the health and safety issue to which the request relates, and requests should explain how the disclosed information would be used to advance efforts in this area.
  • The severity of the health or safety issue to which the request relates, or the vulnerability and size of the affected population.
  • The feasibility of the proposed use of the CBI. A project summary should outline how its objectives will be accomplished with the available expertise and resources.
  • The anticipated impact of the proposed use of the CBI on the health and safety of Canadians.
  • The type of information requested may include:
    • CBI that relates to a therapeutic product that has been authorized for sale in Canada.
    • CBI related to an amendment of a market authorization to obtain approval for new uses or indications for a product already authorized for sale, or authorization for changes that may affect the safety, efficacy or quality of an authorized product. CBI in such submissions or applications may add to the body of knowledge regarding the safety, efficacy and quality of a product to which Canadians are exposed. Consideration should be given to the consequences of disclosure for the integrity of Health Canada's regulatory function, particularly for information related to amendments to a market authorization (for example, supplemental submissions) that are in review, cancelled, withdrawn, or rejected.
    • Information obtained by Health Canada for post-market surveillance purposes, for example, CBI that was provided by a market authorization holder used to conduct a signal assessment or other safety review or to issue a risk communication.
    • Information obtained by Health Canada for compliance and enforcement purposes concerning a therapeutic product for sale in Canada, e.g., CBI that is obtained during the course of an inspection.

4. Protection of Personal Information

Personal information contained within the records considered for disclosure will be protected in accordance with the Privacy Act and other applicable laws Currently available methods of anonymizing personal information may not be suitable for certain records that contain large amounts of structured and unstructured personal information.  Personal information in those records may be separated from other records and assessed under the Privacy Act.
Health Canada will respect the clinical trial participants' consent for data sharing when that information is available.     

5. Protection against Commercial Use

Health Canada will exercise this authority taking into account the importance of protecting CBI against commercial use. Health Canada will only consider projects that describe a non-commercial purpose for the requested information. For the purpose of this authority, commercial purpose means the use of the information to support a marketing authorization anywhere in the world or selling or trading the data to another person.

Health Canada also requires requesters to complete a Conflict of Interest declaration. Health Canada reviews the information provided in the declaration to determine whether or not to disclose CBI to a requester whose financial interests, employment and other affiliations (for example, a role as a witness in litigation or as a consultant to an industry member) could conflict with their commitment to use the CBI exclusively for non-commercial purposes that supports the protection or promotion of human health or the safety of the public.

6. Maintaining Confidentiality of Specified CBI

Where based on a case-by-case assessment Health Canada decides to impose a confidentiality requirement, requesters will be expected to sign a legally binding agreement that applies to CBI specified in the agreement. This agreement provides that the specified CBI can be used only for the purposes of the proposed project and must be kept confidential using appropriate safeguards.

7. Process to Review Requests for Disclosure

Health Canada's decision is based on a rigorous evaluation and a review process that is fair, reasonable and takes into account all relevant factors. The review process is overseen by a committee of senior Health Canada officials mandated to recommend a decision based on relevant technical and scientific expertise. The Review Committee's recommendation is considered by a senior Health Canada official, not involved in the review process, who has been designated to exercise the Minister's authority to disclose CBI under the Food and Drugs Act (section 21.1(3)(c)). Typically, the following key steps in the process can be expected:

  1. Screening: Requests are reviewed to ensure that they are complete, including professional qualifications, mandate of an organization (if applicable), a project description that includes a specific purpose for seeking access to CBI, and a signed Conflict of Interest Declaration. Requesters may be asked to provide missing information required to review their requests.
  2. Record search: Once it has verified that a request includes all required information, Health Canada will conduct a search of its records. The search will identify records that include information described in the request and that are directly related to the project described in the request.
  3. Consultation with requester:  If required, Health Canada will consult the requester to seek further information or clarification it needs to complete its assessment. Additional information on the requester's qualifications and the purpose of the disclosure may be requested to assess whether or not the request meets the requirements of the Act. Where large volumes of records have been identified, the requester may be asked to refine their request. At this stage, Health Canada may identify requested records that do not contain CBI and may be made available through another avenue, e.g. through Health Canada's clinical information portal, or directly from the relevant regulatory bureau.  Where the requested records contain personal information, Health Canada may advise the requester of the methods it would take to protect the personal information, including whether further assessment would be required under the Privacy Act.  
  4. Assessment: Health Canada staff will prepare an assessment based on information provided in complete requests and consultation with requesters. The assessment will describe the requester and the request taking into account the requester's qualifications, the organization's mandate (where relevant) and the proposed project. It will also identify which, if any, information meets the Food and Drugs Act's definition of CBI and consider whether any of the identified CBI should be subject to a confidentiality obligation. The assessment will also indicate whether there is any personal information included in the records, and if so, and how it should be protected in accordance with the Privacy Act and other applicable laws.
  5. Recommendation: Based on its review of the assessment, the Review Committee will prepare a recommendation regarding whether to disclose records containing CBI identified in the record search. The recommendation will include an assessment of whether a request meets the requirements of the Act and an assessment of whether or not the designated decision maker should exercise the Minister's authority to disclose CBI, based on the principles and considerations in section 3 of this guidance document and other factors relevant to the particular request.  The recommendation will identify which information, if any, should be subject to a confidentiality terms and obligations.  It will also identify personal information included in the records and recommend how this personal information should be protected in accordance with the Privacy Act and other applicable laws. Decision: The Review Committee recommendation is considered by a senior Health Canada official designated to exercise the Minister's authority to disclose CBI under the Food and Drugs Act (paragraph 21.1(3)(c)). When Health Canada considers it necessary, based on a case by case assessment, a decision to disclose CBI may be conditional on the requester's agreement to maintain the confidentiality of specified CBI. When the requested information includes personal information, the decision will be made in accordance with the Privacy Act and other applicable laws.  
  6. Notification to requester: Health Canada will notify the requester of its decision. When the decision is to disclose CBI, arrangements will be made to ensure secure transmission of the information to the recipient. When the decision includes a requirement to maintain confidentiality of specified CBI, the requester will be asked to sign an agreement to comply with the required confidentiality obligations prior to disclosure. When the decision is to refuse to disclose CBI, the requester will be notified with an explanation for the decision and advised that they may submit a revised request.
  7. Notification to originator: Health Canada does not notify the originator of the CBI when it is considering a request for disclosure. As a voluntary practice, Health Canada may notify the originator following disclosure of CBI.
  8. Notification of the public: Following the decision to disclose or deny a request, information, about the requester, a description of the project, the request date, date the review was complete, and the review outcome, will be made public. In limited and specific situations, personal information regarding a requester may be disclosed without the requester's consent, in accordance with subsection 8(2) of the Privacy Act.

8. Requirements for Persons Requesting Disclosure of Confidential Business Information under Paragraph 21.1(3)(c)

Requesters should submit a request form to Health Canada with the following information:

  • Personal and contact information for the requester.
  • Professional information for the requester, including professional qualifications, employment and relevant research experience.
  • A description of the information requested, including the therapeutic product and regulatory functions to which the information relates. Requesters are encouraged to consult Health Canada's on-line databases of regulatory information and other resources in order to specify their requests as much as possible.
  • Indication as to whether the requester has exhausted other sources of the information requested, including from the originator of the information.
  • A project summary that clearly indicates the non-commercial purpose of the proposed disclosure and how it relates to the protection or promotion of human health or the safety of the public.
  • How the results of the proposed project will be disseminated to the Canadian public.
  • A completed Conflict of Interest Declaration that provides information required by Health Canada to assess whether or not the requester's financial interests and other affiliations may conflict with their use of the requested information.

The request form can be found on line.

If a request is incomplete, a requester will be asked to provide missing information.

9. Findings Generated From Disclosed Information

Recipients of disclosed information are expected to make the findings of their project with the disclosed information publicly available when the findings provide additional knowledge about the therapeutic product under study. If the recipient of disclosed information has made a determination that the safety, efficacy or quality of a product(s) may change as a result of the evaluation of the CBI then the results should be submitted to Health Canada. Information regarding therapeutic products authorized for the Canadian market should be sent to MHPD-stakeholders_intervenants-DPSC@hc-sc.gc.ca.  Health Canada considers and assesses on a regular basis a multitude of sources when deciding the priority of a potential signal. This includes literature, decisions made in a foreign jurisdiction, as well as information provided by a recipient of CBI, which could lead to the prioritization of a signal for a safety review, and engagement with the affected sponsor.

As always, Health Canada will take the necessary actions to safeguard the health and safety of Canadians should the benefit, harm and uncertainty profile of a product(s) be determined to have changed.

Appendices

Tools for finding regulatory information - Annex A

Health Canada publishes information of interest to Canadians on its regulatory decisions, inspections, compliance and enforcement activities. The information you want may be available publicly on Health Canada's website or databases.

If the information you are seeking is not available publicly and contains CBI, you may be able to obtain it on request from Health Canada. A request for disclosure of CBI should be as specific as possible. Consult the Health Canada web site to learn more about the types of records that may be requested. Useful links include:

Additional information for requesters

There are other authorities in the Food and Drugs Act that permit Health Canada to disclose CBI when there is a risk of serious injury to human health, and for Health Canada to disclose CBI to other government agencies, including regulatory counterparts and members of advisory bodies.

  • Serious risk of injury to human health (section 21.1(2))
  • To a government (section 21.1(3)(a))
  • To a person from whom the Minister seeks advice (section 21.1(3)(b))

For more information on the implementation of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) - (in force November 6, 2014) please refer to the following guide:

Other sources of clinical trial-related information

Clinical trial information is available through the following registries and databases:

Many clinical trial sponsors provide access to clinical data on request, and provide information on-line to assist requesters. 

Yale University Open Data Access project (YODA), is a university-industry partnership that provides access to clinical trial data.

Conflict of Interest Declaration - Annex B

Information Sheet

How to complete the Conflict of Interest Declaration for Disclosure of Information

Please read this information sheet before you complete the Conflict of Interest Declaration for Disclosure of Information.

What to declare?

Each individual is responsible for the declaration of his/her interests, and the interests of their spouse/partner, and/or dependent child. When completing Question 1, you are only required to indicate the company name, and the type of interest, such as stocks, shares, or bonds etc. In order to maintain privacy, do not identify the individual who owns the interest, nor the financial amounts.

Changing circumstances of affiliations and interests

If there is a change in the circumstances reported in the Conflict of Interest Declaration Form during your Project you must promptly report such changes to the Secretariat.

How will the information in my declaration be used?

Health Canada will review your completed declaration form with a view to ensuring that there is no conflict of interest with respect to the information requested for the purpose of carrying out the proposed project related to the protection or promotion of human health or the safety of the public.

Protection of personal information

Once completed, your personal information in the Conflict of Interest Declaration for Disclosure of Information is protected in accordance with the Privacy Act.

Before you mail your completed declaration

Before you send this application form to the Secretariat, please make sure that you have completed, signed and dated your declaration.

Sample

Conflict of Interest Declaration for Disclosure of Information

To be completed by individuals requesting disclosure of information for the purposes of a project that relates to the protection or promotion of human health or safety of the public.

Section A - Personal information

  • Prefix
    • Mr.
    • Mrs.
    • Ms.
    • Miss
  • First Name
  • Last Name
  • Home Address (No., Street, Apt., P.O. Box, R.R)
    • City Prov./Territory
    • Postal Code
    • Country
  • Mailing Address
    • Same as above Or (No., Street, Apt., P.O. Box, R.R)
    • City
    • Prov./Territory
    • Postal Code
    • Country
  • Daytime Phone Number
  • Evening Phone Number
  • Preferred language for receiving future communications:
    • French or
    • English

Section B – Information about your affiliations and interests

Direct Financial Interests

Q 1) Do you, your spouse/partner, and/or dependent minor child have any direct financial interests with the regulated industry that are of relevance to the subject of the information request including current employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares, or bonds?

  • Yes
  • No

If yes, please list the company name, and the type of interest. In order to maintain privacy, household members do not need to be identified.

Response:

Indirect financial interests

Q 2) Within the past five years, have you received from the regulated industry payment for work done or being done, or financial support, of relevance to the subject of the information request? Include past employment, contracts or consulting, research support, personal education grants, contributions, fellowships, sponsorships, and honoraria for teaching, speaking, or writing engagements.

Note: if you are currently employed by the regulated industry and have declared this under Q1), do not include any of the above from your present employer.

  • Yes
  • No

If yes, please list the approximate value. When was the work performed? What was your role? Who provided the support? When did the support cease?

Response:

Q 3) Within the past five years, have you received materials, discounted products, gifts, or other benefits, or attended conferences or meetings where all or part of the travel and accommodation costs were provided by the regulated industry, of relevance to the subject of the information request.

Note: if you are currently employed by the regulated industry and have declared this under Q1), do not include any of the above from your present employer.

  • Yes
  • No

If yes, please provide the dates and details, including who provided the support and the approximate value.

Response:

Q 4) Within the past three years, have any of the organizations where you are currently employed or where you participate in internal decision making (that is, as a board member, or as an executive or non-executive director) received grants or other funding from the regulated industry, of relevance to the subject of the information request?

  • Yes
  • No

If yes, please provide the dates and details, including who provided the support, and the amounts.

Response:

Intellectual interests

Q 5) Within the past five years, have you provided any formal advice or opinion to industry, a Canadian federal, provincial, or municipal government, a foreign government, or a non-government organization, on a matter of relevance to the subject of the information request? Include expert testimony or acting as witness (full or part time), participation on an advisory body, etc.

  • Yes
  • No

If yes, please provide the dates and details and note if you volunteered your services or were paid.

Response:

Q 6) Have you ever made public a statement (including speeches, lobbying, etc.) or publicly stated a point of view (including in scientific papers, articles, journals, or other publications or on Web sites) on issues of relevance to the subject of the information request?

  • Yes
  • No

If yes, please list by date, title, and publication

Response:

Q 7) Do you currently have any professional or volunteer affiliations (such as membership of professional/scientific societies, trade associations, lobbying, public interest or advocacy groups, etc.) who may have an interest in the subject of the information request?

  • Yes
  • No

If yes, please describe.

Response:

Other affiliations and interests

Q 8) Do you have any other affiliations and interests or potential circumstances that might give a well-informed member of the public reasonable apprehension or grounds for concern that access to the information for which you have requested disclosure could place you in a conflict of interest?

  • Yes
  • No

If yes, please describe.

Response:

Section C - Your declaration

I [...] name have reviewed my affiliations and interests as they relate to the matters itemized in this disclosure form, and I hereby certify that I have disclosed all relevant information. Except as otherwise disclosed in this form, I declare that I have no additional relevant affiliations and interests to report.

I understand that it is my responsibility to report to the Secretariat any material change in circumstances in my affiliations and interests as soon as it is known to me.

  • Name of individual requesting disclosure of information
  • Signature
  • Date YY / MM / DD

Please return your completed form to: CBI Secretariat Information Sciences and Openness Division Resource Management and Operations Directorate Health Products and Food Branch, Health Canada 250 Lanark Ave, Ottawa, Ontario Canada, K1A 0K9

Privacy notice 

The personal information you provide to Health Canada is governed in accordance with the Privacy Act.  We only collect the information we need to process requests for confidential business information (CBI) authorized under paragraph 21.1(3)(c) of the Food and Drugs Act.

Purpose of collection: Your personal information is used to determine whether requested CBI may be disclosed to you.  This information will be reviewed by a committee of senior Health Canada officials in order to ensure that there is no conflict of interest with respect to the information requested.

Other uses or disclosures: Health Canada may notify the public and/or the originator of the requested information of your request for CBI. In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8(2) of the Privacy Act.

Refusal to provide the information: Failure to provide the requested information will prevent the assessment and processing of your request under paragraph 21.1(3)(c).

For more information: This personal information collection will be described in Info Source, available online at infosource.gc.ca. Refer to the personal information bank (to come).

Your rights under the Privacy Act: In addition to protecting your personal information, the Privacy Act gives you the right to request access to and correction of your personal information. For more information about these rights, or about our privacy practices, please contact Health Canada's Privacy Coordinator at 613-954-9165 or privacy-vie.privee@hc-sc.gc.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.

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