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Health Canada's policy on providing guidance on regulatory requirements

How Health Canada helps regulated parties understand their regulatory obligations.

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Overview

Health Canada's Policy on Providing Guidance on Regulatory Requirements outlines our commitment to engaging with stakeholders to help them understand our regulatory requirements.

The policy lays out our approach to providing guidance through a range of practices and tools used to engage with and serve businesses, regulated parties and other stakeholders in a timely and professional manner. This includes providing businesses and regulated parties with information on their regulatory obligations.

Specific approaches for particular products may differ. For example, international treaties and conventions will have program-specific requirements, such as the World Health Organization's Framework Convention on Tobacco Control.

Guidance on regulatory requirements help strengthen our compliance and enforcement programs. Learn about our approach to compliance and enforcement, including roles and responsibilities, actions and tools, guiding principles and decision factors:

What we do

Health Canada is the federal department responsible for helping people in Canada maintain and improve their health. The information we provide helps them make informed, safe and healthy choices.

Health Canada relies on scientific evidence and data to ensure that high quality products and services are accessible to people in Canada. Our purpose is to reduce the risks to people's health and the environment. We use this evidence when developing policies and are committed to transparency and openness when making regulatory decisions. We also collaborate with other partner organizations in the health portfolio as well as other departments on joint regulatory initiatives. The following 2 plans are examples of such work:

Health Canada regulates the use of thousands of products and delivers a range of programs and services. We regulate many areas that may pose health risks, such as:

  • pesticides
  • air pollutants
  • veterinary drugs
  • natural health products
  • devices that emit radiation
  • workplace hazardous products
  • chemicals and living organisms
  • food, drugs and medical devices
  • consumer products and cosmetics
  • controlled substances and precursor chemicals
  • alcohol, cannabis, tobacco and vaping products

How we develop policy, regulatory and guidance documents through stakeholder

Health Canada regularly consults with regulated parties, the public, Indigenous Peoples as partners, other levels of government and other stakeholders on regulatory initiatives. We use their input to inform the development of policies, legislation, regulations, programs and guidance.

Engaging with all stakeholders through the consultation process helps us:

  • design flexible, adaptable, efficient, effective, risk and evidence-based regulatory requirements and processes to achieve operational flexibility, efficiencies and innovation
  • respond to emerging issues, while maintaining, as our top priority, the health and safety of people in Canada

Learn more about the public engagement process:

Learn more about consultation opportunities:

If you're interested, you may also subscribe to our registry to:

  • participate in consultations
  • take part in research activities such as surveys
  • receive information on regulatory requirements for chosen health topics

Subscribe:

Building awareness of regulatory requirements

Regulated parties are expected to understand the relevant laws and regulations that concern their regulated activities and products.

Health Canada engages with regulated parties, stakeholders, the public and other groups to raise awareness and understanding of existing and proposed regulatory requirements. We use a number of engagement tools, such as:

  • surveys
  • webinars
  • meetings
  • roundtables
  • consultations
  • advisory committees
  • social media postings

We use the feedback from these engagements to plan and prepare materials to promote regulatory compliance, where appropriate. In some cases, other players are responsible for monitoring compliance with regulatory requirements. Examples include:

Compliance promotion activities focus on raising awareness and educating regulated parties about their obligations. In some instances, we publish policies and guidance documents to help regulated parties understand:

  • processes to be followed
  • scientific standards or principles that will be applied
  • possible consequences for noncompliance

The guidance documents also help regulated parties interpret legislation and encourage the adoption of best practices. Examples of the types of guidance documents and other relevant information we provide include:

  • reports and publications about issues that affect the health and safety of people in Canada
  • guidelines on Canada's health care system and legislation
  • guidance documents to help interpret policies, governing statutes and regulations
  • guidance documents for applicants and licensed producers on the licence application process and regulatory requirements

However, guidance documents are not legally binding and should be read along with the relevant legislation. If there's any discrepancy between the legislation and guidance documents, the legislation stands. Thus, regulated parties should be aware of and review all legislation that may apply to them or their activities, including any other applicable federal, provincial or territorial legislation.

We're committed to plain language

Health Canada is committed to developing clear, accurate, accessible and plain language communications products. This includes guidance materials, regulatory decision summaries, information bulletins and policy documents, in both official languages.

Our products clarify expectations and outline requirements. They're adapted to meet the needs of regulated parties and sectors.

Learn more:

How we respond to general enquiries and regulatory concerns

Health Canada receives enquiries, complaints and concerns on matters relating to the products and services we regulate.

General enquiries

Health Canada tries to respond to enquiries in a timely, clear, consistent and professional manner, and to provide as much information as we can.

We respond in the official language used by the person making the enquiry in accordance with the Official Languages Act and official languages policy.

Health Canada also responds to enquiries in the form that the enquiry is made (orally or in writing). Written responses are also provided when:

  • the person has asked for a response
  • the nature or complexity of the information calls for a response

Note: Health Canada does not provide legal advice on specific Acts or regulations and how they may be applied to particular circumstances or on whether a product or an action is compliant. However, we do regularly communicate how regulated parties and the public are to comply with various acts and regulations under our administration. These responses and those to individuals are not binding on Health Canada unless we communicate otherwise to the stakeholder.

Regulatory concerns

Health Canada identifies, manages and addresses feedback, as well as resolves disputes at the level at which they occur. Dispute prevention and early resolution help minimize the impacts of complaints and disputes, and improve relations between Health Canada and stakeholders.

We try to address concerns raised by regulated parties and stakeholders through our feedback or complaints processes.

We established tools to help simplify certain reports. You may:

A regulated party may appeal a Health Canada inspector's decision about an inspection. Mechanisms are available to document any concerns over an inspection result or process, and depend on the particular program or legislation in question. However, the original decision made by the inspector is valid until a re-assessment or re-inspection has been completed.

Learn more:

Our service standards and commitment to professional service

Response times

Health Canada's service standards publicly outline the level of performance that regulated parties and stakeholders can reasonably expect to receive under normal circumstances. The standard for responding to an enquiry may vary across our department. How quickly a program replies will depend on the number of enquiries it receives at a given time and on the complexity and nature of the enquiry.

Health Canada also has standards for regulatory authorizations. We track and review turnaround times to assess our performance against these service standards.

Learn more:

Professional service

Health Canada is committed to providing professional, timely, impartial, courteous and respectful service. All employees are expected to be reasonable, professional, transparent, unbiased and without prejudice.

We also ask that those who contact us be equally courteous and respectful.

Standard operating procedures provide staff with the tools to attain excellence in service when working with stakeholders. Internal guidance documents also provide assistance to staff on how we implement our mandates, objectives and programs fairly, consistently and effectively.

Through learning opportunities, we strive to ensure that staff have the necessary skills and technical knowledge to provide quality service and accurate information on regulatory requirements.

Learn more:

Contact us

For enquiries about this policy:

Departmental Regulatory Affairs
Health Canada
200 Eglantine Driveway, 7th Fl
Email: dra-arm@hc-sc.gc.ca

For general enquiries or to find contact information on a specific program or area:

Related links

For program-specific information:

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