Legislation and Guidelines

Health Canada administers many pieces of legislation and develops and enforces regulations under this legislation that have a direct impact on the health and safety of Canadians. The Department consults with the Canadian public, industry, non-governmental organizations (NGOs) and other interested parties in the development of these laws. Health Canada also prepares guidelines in order to help interpret and clarify legislation and regulations.

What is Legislation?

Legislation refers to written laws, often referred to as Acts or statutes, which are enacted by Parliament, the legislative arm of government. Draft legislation, called a bill, is introduced to Parliament and requires the assent of the House of Commons, the Senate and the Crown to become law.

What are Regulations?

Regulations are a form of law, sometimes referred to as subordinate legislation, which define the application and enforcement of legislation. Regulations are made under the authority of an Act, called an Enabling Act. Regulations are enacted by the body to whom the authority to make regulations has been delegated in the Enabling Act, such as the Governor in Council or a minister, etc.

What are Guidelines?

Guidelines are departmental documents that are used to interpret legislation and/or regulation. Although they may be derived from legislation and are often used to advise how one might comply with a regulation, guidelines do not have the force of law.

What Information is Available?

In this section, you will find a listing of the Acts for which Health Canada has total or partial responsibility, a listing of Acts in which Health Canada has a special interest and a listing of regulations made under each of the acts directly administered by Health Canada. In addition, you will find some information about how Health Canada engages in international regulatory cooperation and about Health Canada's contribution to government-wide efforts to modernize the Canadian regulatory system.