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. For Health Canada's approach to compliance and enforcement, including roles and responsibilities, actions and tools, guiding principles and decision factors, please consult Health Canada's Compliance and Enforcement Policy Framework.

Health Canada's Policy on Providing Guidance on Regulatory Requirements outlines the Department's commitment to build awareness of regulatory requirements through the delivery of timely, professional service and meaningful stakeholder engagement. The Department uses a variety of practices and tools to respond to enquiries, and provide businesses and regulated parties with guidance and information on regulatory obligations.

This policy outlines the general approach to providing guidance on regulatory requirements at Health Canada. Specific approaches relating to particular products may differ, when taking into account other obligations (for example, program-specific requirements under international treaties and conventions such as the World Health Organization Framework Convention on Tobacco Control).

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 transparency and openness in its regulatory decisions. Health Canada also collaborates with other partner organizations in the Health Portfolio on joint regulatory commitments (such as the Agri-food and Aquaculture Sectoral Regulatory Review Roadmap and the Health and Biosciences Sectoral Regulatory Review Roadmap).

The Department regulates and approves the use of thousands of products and delivers a range of programs and services. Health Canada regulates many areas that can pose health risks, such as:

• air pollutants
• alcohol
• cannabis
• chemicals
• consumer products
• controlled substances and precursor chemicals
• cosmetics
• devices that give off radiation
• drugs
• food
• medical devices (such as pacemakers, artificial heart valves, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices)
• natural health products
• pesticides
• tobacco products
• vaping products
• veterinary drugs
• workplace hazardous products

Health Canada provides information to Canadians to help them make informed, safe and healthy choices. Health Canada also communicates health and safety risks to Canadians; for example, information on recall and safety alerts is available.

Building an awareness of regulatory requirements

Regulated parties are expected to understand relevant laws and regulations with respect to all regulated activities and products.

Health Canada communicates regularly with its stakeholders and regulated parties through a variety of means to facilitate the development of guidance documentation, and more broadly to ensure awareness and promote compliance with regulatory requirements. In some instances, the responsibility for monitoring compliance with regulatory requirements lies with other partner organizations within the Health Portfolio (for example the Canadian Food Inspection Agency) as well as other government departments (for example Environment and Climate Change Canada).

Plain language commitment

Health Canada endeavours to develop products in both official languages (such as guidance material, regulatory decision summaries, information bulletins, policy documents) that use clear, accurate, accessible and plain language and are adapted to the needs of regulated sectors to clarify expectations and outline requirements. The Department adheres to the Government of Canada's Policy on Communications and Federal Identity and the accompanying Directive on the Management of Communications.

Our approach to policy, regulatory, and guidance development

Health Canada regularly consults with one or more groups, such as regulated parties, the public, Indigenous Peoples as partners, other levels of government, and other stakeholders, to seek input to inform regulatory initiatives. The input obtained through the consultation process is considered in the development of policies, legislation, regulations, and guidance. The Department emphasizes engagement to help design flexible, efficient, and adaptable regulatory requirements and processes that allow for innovation or respond to emerging issues, while maintaining, as Health Canada's top priority, the health and safety of Canadians.

Health Canada is committed to applying best practices in public engagement as outlined in the Health Canada and Public Health Agency of Canada Guidelines on Public Engagement. Information related to consultation opportunities is available on the Consulting with Canadians website and on Health Canada's two-year Forward Regulatory Plan. Interested parties can also subscribe to Health Canada's Stakeholder Registry (the Consultation and Stakeholder Information Management System). This registry allows interested parties to receive information on regulatory requirements related to chosen health topics, to participate in consultations, and to take part in research activities such as surveys.

Our approach to building regulatory awareness

Health Canada engages with regulated parties, stakeholders, and other groups or the public through mechanisms such as advisory committees, roundtables, bilateral meetings, consultations, social media postings, and surveys, to promote the regulated parties' 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 with regulatory requirements through educational activities and information sharing on legislative and regulatory matters (such as webinars and stakeholder notifications). Compliance promotion activities focus on raising awareness and educating regulated parties about their obligations. In some instances, the Department publishes policies and guidance documents to help regulated parties understand Health Canada's processes to be followed, the scientific standards or principles that will be applied, and the possible penalties for noncompliance.

Health Canada may develop guidelines to help regulated parties interpret legislation and to encourage the adoption of best practices. Specifically, guidance documents should be read in conjunction with the relevant legislation. In the event of any discrepancy between the legislation and guidance documents, legislation prevails. Regulated parties should be aware of and consult all legislation that may apply to them or their activities, such as any other applicable federal, provincial or territorial legislation. Health Canada does not provide legal advice on specific regulations and how they 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.

Guidance documents and other relevant information on a wide range of topics are also available, including:

• reports and publications about various issues that affect the health and safety of Canadians
• information regarding consumer product safety, food and nutrition, drugs and health products, pesticides, controlled substances, tobacco products, vaping products, cannabis, environment safety and protection, and workplace hazardous products
• guidelines on Canada's health care system and legislation
• guidance documents to assist in the interpretation of policies, governing statutes, and regulations
• guidance documents for applicants and licensed producers, on the licence application process and regulatory requirements

To help answer commonly asked questions, program specific information is available in the following webpages:

• Cannabis
• Chemical safety
• Consumer product safety
• Controlled substances and precursor chemicals
• Drugs and health products
• Food and nutrition
• Pesticides
• Tobacco
• Vaping
• Workplace hazardous products

Responding to enquiries

Health Canada aims to respond to enquiries 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 enquirer's choice, in accordance with the requirements of the Official Languages Act and Policy on Official Languages. Generally, the response is provided 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 enquirer
• when an enquiry is received in writing
• when it is preferable to provide information in writing due to the nature or complexity of the information being provided

Our 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. However, service standards with respect to response timeliness vary across the Department and depend on the volume of enquiries a program receives and the complexity and nature of the enquiry itself.

To contact Health Canada for general enquiries or to find contact information on a specific program or area, consult the Contact Health Canada webpage.

Commitment to professional service

Health Canada commits to excellence in service by providing professional, timely, impartial, courteous and respectful service. The Department requests from anyone making an enquiry to do so in a courteous and respectful manner.

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. Health Canada's timeliness standards for such authorizations clarify expectations and increase predictability in the federal regulatory system. Health Canada tracks and reviews turnaround times to verify that it is completing reviews and providing responses to stakeholders in accordance with published service standards.

All Health Canada employees are expected to perform their duties in ways that are reasonable, professional, transparent, unbiased and unprejudiced, and must 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 conducted by its specialized inspectors across all applicable areas.

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 Health Canada implements its mandates, objectives, and programs in a fair, consistent and effective way.

Stakeholder Engagement and Responding to Complaints

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

Health Canada strives to improve relations between external stakeholders and its representatives, as well as to increase openness and transparency in the regulatory process. The Department receives complaints, concerns or enquiries about alleged acts, omissions, improprieties and broader systemic problems on matters pertaining to the products and services it regulates and helps the parties arrive at a mutually agreed upon resolution.

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

There are also avenues available to submit an online incident report involving cannabis, a consumer product or cosmetic, a health product, a pesticide, or to report a drug shortage or discontinuation. Other types of incident reports can also be submitted on the Health Canada website.

Enquiries

For enquiries regarding this policy please contact:
Departmental Regulatory Affairs
Health Canada
200 Eglantine Driveway, 5^th Floor
hc.dra-arm.sc@canada.ca

Date of last revision of this policy

March 31, 2021