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Guide to the precision regulation authorities under the Food and Drugs Act: Supplementary rules authority

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Sections 30.01 and 30.02

The following subsections of the Food and Drugs Act (FDA) set out the supplementary rules authority.

Subsection 30.01(1), the authority to set out supplementary rules for a therapeutic product:

"Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes on reasonable grounds that the use of a therapeutic product, other than the intended use, may present a risk of injury to health, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the therapeutic product for the purpose of preventing, managing or controlling the risk of injury to health."

Subsection 30.01(2), the authority extends to promotion:

"For greater certainty, the Minister may, in the order, establish rules for the purpose of preventing the therapeutic product from being promoted for a use, other than the intended use, of a therapeutic product or preventing a use, other than the intended use, of a therapeutic product from being appealing."

Subsection 30.01(3), the authority to make an order when there is uncertainty:

"The Minister may make the order despite any uncertainty respecting the risk of injury to health that the use of the therapeutic product, other than the intended use, may present."

Subsection 30.02(1), the authority to set out supplementary rules for drugs intended for animals:

"Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes on reasonable grounds that the use of a drug intended for an animal of a particular species, including a use other than the intended use, may present a risk of adverse effects to human beings, animals of a different species or the environment, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the drug for the purpose of preventing, managing or controlling the risk of adverse effects."

Subsection 30.02(2), the authority to make an order when there is uncertainty:

"The Minister may make the order despite any uncertainty respecting the risk of adverse effects that the use of the drug, including a use other than the intended use, may present."

Scope of the supplementary rules authority

Orders under the supplementary rules authority

There are 2 types of orders under this authority:

The supplementary rules authority under section 30.01 and 30.02 of the FDA applies to a single person, such as an individual company, or a class of persons in relation to a:

Supplementary rules orders cannot be made for cosmetics or foods. They also do not apply to animal vaccines or animal medical devices that are regulated under the Health of Animals Act.

For class orders, the class of therapeutic products depends on the situation at hand and is determined when the order is being developed.

Only the Minister may make, amend or revoke a supplementary rules class order under section 30.01 or 30.02 of the FDA. These activities cannot be delegated to officials.

For person-specific supplementary rules orders, the Minister can delegate the making, amending or revoking to officials, as appropriate.

Section 30.01, supplementary rules for therapeutic products

This authority allows the Minister, on reasonable grounds, to make an order establishing rules for importing, selling, conditions of sale, advertising, manufacturing, preparing, preserving, packaging, labelling, storing or testing a therapeutic product or class of therapeutic products. The purpose of the order is to prevent, manage or control the risk of:

As indicated in subsection 30.01(3) of the FDA, the Minister may make an order, under section 30.01, even if there is any uncertainty about the risk of injury to health an unintended use of the therapeutic product or class of therapeutic products may present. The order allows Health Canada to take precautionary action to address an emerging health and safety risk where evidence is still developing.

Section 30.02, supplementary rules for drugs intended for animals

This authority allows the Minister, on reasonable grounds, to make an order establishing rules for importing, selling, condition of sale, advertising, manufacturing, preparing, preserving, packaging, labelling, storing or testing a drug or class of drugs intended for an animal. The purpose of the order is to prevent, manage or control the risk of:

As indicated in subsection 30.02(2) of the FDA, the Minister may make an order, under section 30.02, even if there is any uncertainty about the risk of adverse effects the drug or class of drugs intended for use in animals may present. The order allows Health Canada to take precautionary action to address an emerging health and safety risk where evidence is still developing.

Off-label use recommended by a health care provider

Off-label use refers to a therapeutic product being used in a way that has not been authorized by Health Canada. Health care providers may recommend off-label use of therapeutic products in their practice using their clinical expertise and judgment and under the oversight of the applicable provincial or territorial regulator. The supplementary rules authority is not intended to affect the off-label use of therapeutic products recommended by health care providers.

When an order is being considered under this authority, Health Canada will consult with any relevant partners as necessary. This includes, for example, provincial or territorial health system partners or associations representing health care providers.

Process for making a supplementary rules order

If we determine that a supplementary rules order under these authorities is the best option to address the issue at hand, officials will conduct the necessary analysis to support the order being developed.

Consultation

We will consult with relevant stakeholders and health system partners during the development of a supplementary rules order. These consultations may take different forms depending on such things as the number of stakeholders and partners who are affected or the urgency of the situation.

Publication

Supplementary rules class orders are subject to both the Statutory Instruments Act and the Cabinet Directive on Regulation and are published in the Canada Gazette, Part II.

A supplementary rules class order or person-specific order may include, as applicable, the:

Where necessary, supporting information such as guidance or procedures will be developed and published.

Person-specific supplementary rules orders will not be published in the Canada Gazette, Part II, but will be published on the Government of Canada website. Where necessary, we may redact certain information before publishing an order, for example, to protect a person's privacy or confidential business information.

After a supplementary rules order is made

Once an order is made, officials will assess over time whether it should remain or be updated, repealed or incorporated into our regulations of general application. An example would be if emerging information indicates the risk associated with the therapeutic product or class of therapeutic products has changed.

Refer to the Definitions and interpretations page for definitions on confidential business information, food, Minister, Ministerial order, person and therapeutic product.

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