Health Canada's Policy on Providing Guidance on Regulatory Requirements

This policy outlines Health Canada’s approach to helping regulated parties understand their regulatory obligations.

Health Canada’s ‘Policy on Providing Guidance on Regulatory Requirements’ is an overarching document that illustrates the department’s commitment to building awareness of regulatory requirements through the delivery of timely, professional service and meaningful stakeholder engagement. The department utilizes a variety of practices and tools to respond to enquiries and provides Canadians and businesses with guidance and information on their regulatory obligations.

The information outlined in this policy is applicable to all branches of Health Canada.

Departmental context

Health Canada is the federal department responsible for helping Canadians maintain and improve their health. Health Canada strives to ensure that high-quality health services are accessible, and works to reduce risks to individual health and the environment. Health Canada relies on high-quality scientific evidence as the basis for its policies and work, and is committed to greater transparency and openness to further strengthen trust in its regulatory decisions.

The department regulates and approves the use of thousands of products and delivers a range of programs and services in environmental health and protection, and has responsibilities in the areas of problematic substance use, tobacco policy, workplace health, and the safe use of consumer products. The products and health risks Health Canada regulates include:

  • cosmetics
  • food
  • drugs
  • veterinary drugs
  • natural health products
  • medical devices (such as pacemakers, artificial heart valves, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices)
  • devices that give off radiation
  • pesticides
  • chemicals
  • tobacco and vaping products, alcohol
  • controlled substances and precursor chemicals (such as ephedrine and pseudoephedrine, chemicals that are essential for the production of controlled substances)
  • cannabis
  • environmental health risks (such as radon, water quality, climate change, chemical safety, radiation in the environment, indoor and outdoor air quality, noise risks)
  • workplace safety.

Building an awareness of regulatory requirements

There is an expectation that regulated parties understand the relevant law and their obligations with respect to all regulated activities.

Health Canada communicates regularly with its stakeholders (e.g., the public, regulated parties, private sector) through a variety of means to facilitate the development of guidance documentation, and more broadly to ensure awareness of and promote compliance with regulatory requirements.

The department endeavours to develop products (e.g., guidance material, regulatory decision summaries, information bulletins) that use plain language and are adapted to the needs of each regulated sector to clarify expectations and outline requirements.

Our approach to policy, regulatory, and guidance development stages

Health Canada regularly conducts consultations with the public and other interested stakeholders, including Indigenous peoples, to hear Canadians’ thoughts on a particular issue. The input obtained during these exchanges helps to inform the development of policies and legislation that reflect the concerns of Canadians. The department places an emphasis on collaboration in the design of flexible, efficient, and adaptable regulatory requirements and processes that accommodate innovation, while maintaining as Health Canada’s top priority, the health and safety of Canadians.

Information related to consultation opportunities is available on the Consulting with Canadians website and on Health Canada’s two-year Forward Regulatory Plan. Canadians and stakeholders can also subscribe to the Health Canada Stakeholder Registry (Consultation and Stakeholder Information Management System), which allows interested parties to choose to receive information on regulatory requirements related to chosen health topics, participate in consultations, and take part in research activities such as surveys.

Our approach to building regulatory awareness

Health Canada engages with regulated parties and stakeholders through mechanisms such as advisory committees, roundtables, bilateral meetings, online consultations, social media postings, and surveys, to promote the public’s awareness and understanding of existing and proposed regulatory requirements. The department uses this feedback to plan and prepare materials and activities to promote regulatory compliance, where appropriate.

Health Canada promotes compliance through educational activities and information sharing on legislative and regulatory matters. Compliance promotion activities are focused on raising awareness and educating regulated parties about their obligations. The department publishes policies and guidance documents so that regulated parties understand Health Canada’s interpretation of the legislation, the processes to be followed and the scientific standards or principles that will be applied.

Health Canada also provides information to consumers to help them make informed, safe and healthy choices. Health Canada communicates health and safety risks to Canadians; for example, consumers can find recall and safety alerts on Health Canada’s website.

Guidance documents and other relevant information can be accessed on the Canada.ca website; such as:

  • reports and publications about various issues that affect the health of Canadians,
  • information regarding consumer product safety, food and nutrition, drugs and health products, controlled drugs, tobacco and vaping products, cannabis, environmental and workplace health and safety, and
  • guidelines on Canada’s health care system and legislation.

As an example, in October 2018, the Cannabis Act and supporting regulations came into force, thereby putting in place a new, strict framework for controlling the production, distribution, sale and possession of cannabis in Canada. To help Canadians and regulated parties understand these changes, Health Canada undertook a multi-pronged approach to communications, including a dedicated website Cannabis in Canada, Cannabis Education Resources, and a postcard-sized mail-out sent to all Canadians entitled The Cannabis Act: Here’s What You Need to Know. The department also executed a significant public education campaign, which included the national Pursue Your Passion tour, the Your Cannabis Questions, Answered advertising campaign, and the #FocusedOn partnership with the Canadian Hockey League, all to help ensure that Canadians had information about the health effects of cannabis use, as well as what the new laws would mean to them.

Responding to enquiries

Health Canada responds to enquiries from Canadians and stakeholders in a timely, clear, consistent, and professional manner with the intent to be as informative as possible.

Health Canada commits to responding to enquiries in the official language of the inquirer’s choice, in accordance with the requirements of the Official Languages Act and Policy on Official Languages, and generally in the form that an enquiry is made, whether orally or in writing, or as appropriate.

When can you expect to receive a response in writing?

The conditions under which Health Canada will respond to enquiries in writing include:

  • when a written response is requested by the stakeholder,
  • when an inquiry is received in writing, or
  • when it is preferable to provide information in writing due to the nature or complexity of the information being provided.

Our service standards and practices support providing timely and consistent responses

Health Canada’s service standards publicly state the level of performance that citizens can reasonably expect to receive under normal circumstances. Service standards with respect to timeliness vary across the Department depending on the volume of enquiries a program receives and the complexity of the enquiry itself.

For example, the service standard for the Pesticide Compliance Program is to acknowledge receipt of all inquiries and complaints within two business days and to provide a final response within 21 calendar days, depending on the nature and complexity of the issue, while the Food and Drugs Act Liaison Office (FDALO) strives to acknowledge receipt of all mail or toll-free line enquiries within 24 hours. Within a week of receiving the initial enquiry, FDALO then examines the nature of the request and communicates the approximate time frame it will take to respond.

Health Canada develops guidelines to help interpret and clarify legislation and regulations and to encourage the adoption of best practices. Health Canada does not, however, provide legal advice about how specific regulations may be applied to particular circumstances or whether or not a product or an action is deemed to be compliant. Responses to individual enquiries are not binding on the department unless the department communicates otherwise to the stakeholder.

The department uses Frequently Asked Questions (FAQs) to address recurring enquiries and to facilitate the sharing of clear and consistent information. FAQs are available on the Canada.ca web site.

Commitment to professional service

Health Canada commits to excellence in service when dealing with all stakeholders, by providing professional, timely, impartial, courteous and respectful service.

Health Canada strives to ensure that staff who have a responsibility to respond to enquiries have the necessary skills and technical knowledge to provide quality service and accurate information on regulatory requirements. Learning opportunities are provided to Health Canada employees regarding service-related knowledge and client-service excellence.

Tools and practices that guide our conduct and actions

Information related to service standards for high-volume regulatory authorizations is available on the Canada.ca website. Health Canada’s timeliness standards clarify expectations and increase predictability in the federal regulatory system. Health Canada offices track and review their turnaround time to verify that they are completing reviews and providing responses to stakeholders in accordance with published service standards.

Health Canada inspectors are expected to perform their duties in ways that are reasonable, professional, transparent, unbiased and unprejudiced, and to follow the Values and Ethics Code for the Public Sector and the Health Canada Values and Ethics Code at all times. The Guide to Health Canada Inspections describes, in a general manner, the practices for Health Canada inspections across all applicable Acts and regulations.

Standard operating procedures are maintained to provide staff with the tools to attain excellence in service when working with stakeholders. Offices revisit their service procedures on a regular basis to identify opportunities for improvement. 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.

Stakeholder engagement

Health Canada is committed to identifying, managing and addressing feedback, and resolving disputes at the level at which they occur. Dispute prevention and early resolution are key to minimizing the impacts of complaints and disputes, and to improving relations between Health Canada and its stakeholders.

Health Canada will address concerns raised by stakeholders related to their understanding of regulatory requirements through existing feedback or complaints processes.

Examples of the avenues available to stakeholders for providing feedback on regulatory decisions, service delivery and regulated products

The Food and Drugs Act Liaison Office (FDALO) serves to improve relations between external stakeholders and representatives of Health Canada, as well as to increase openness and transparency in the regulatory process. FDALO receives complaints, concerns or enquiries about alleged acts, omissions, improprieties and broader systemic problems on matters pertaining to the Food and Drugs Act and acts as an intermediary to help the parties arrive at a mutually agreed upon resolution.

A regulated party may contest a Health Canada inspector's decision relating to an inspection. Depending on the particular program or legislation, mechanisms are available to document any concerns over an inspection result or process. Additional information can be found in the Guide to Health Canada Inspections.

There are also avenues available for stakeholders to report an incident involving a consumer product, pesticide or cosmetic online.

In addition, Canadians who become aware of a drug shortage or discontinuation that is not reported on Drug Shortages Canada, are encouraged to contact Health Canada at hc.drug.shortages-penurie.de.medicament.sc@canada.ca.

Date of last revision of this policy

March 31, 2019

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