Food and Drugs Act (R.S.C., 1985, c. F-27)

Supplementary Rules

Marginal note:Supplementary rules — therapeutic product

• 30.01 (1) 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.

• Marginal note:Promotion

  (2) 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.

• Marginal note:Uncertainty

  (3) 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.

Marginal note:Supplementary rules — drug intended for animal

• 30.02 (1) 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.

• Marginal note:Uncertainty

  (2) 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.

Marginal note:Statutory Instruments Act

30.03 An order made under subsection 30.01(1) or 30.02(1) that applies to only one person is not a statutory instrument within the meaning of the Statutory Instruments Act.

Marginal note:Availability — person-specific orders

30.04 The Minister must ensure that any order made under subsection 30.01(1) or 30.02(1) that applies to only one person is publicly available but may exclude personal information and confidential business information from the order.

Exemption

Marginal note:Exemption — foods and therapeutic products

• 30.05 (1) Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, on any conditions that the Minister considers necessary, exempt — other than in relation to cosmetics — a class of foods, therapeutic products, persons or activities from the application of all or any of the provisions of Part I, section 37 or the regulations.

• Marginal note:Preconditions

  (2) The Minister may make an order only if the Minister believes on reasonable grounds that

  • (a) it is necessary for a health or safety purpose or is otherwise in the public interest; and

  • (b) having regard to its benefits and conditions, it is unlikely to result in

    • (i) unacceptable health, safety or, if applicable, environmental risks, or

    • (ii) an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks.

• Marginal note:Obligation to comply with conditions

  (3) Any person to whom a condition applies must comply with that condition.

Decision of Foreign Regulatory Authority

Marginal note:Deeming order

• 30.06 (1) Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, deem that specified requirements of this Act or the regulations are met — in respect of a therapeutic product or food that belongs to a class specified in the order — on the basis of a decision of, or any information or document produced by, a foreign regulatory authority in respect of that therapeutic product or food.

• Marginal note:Preconditions

  (2) The Minister may make the order only if the Minister believes on reasonable grounds that

  • (a) it is necessary for a health or safety purpose or is otherwise in the public interest; and

  • (b) having regard to its benefits and conditions, it is unlikely to result in

    • (i) unacceptable health, safety or, if applicable, environmental risks, or

    • (ii) an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks.

• Marginal note:Power to impose conditions

  (3) The Minister may, in the order, impose any conditions that the Minister considers necessary.

• Marginal note:Obligation to comply with conditions

  (4) Any person to whom a condition applies must comply with that condition.

• Marginal note:Clarifications

  (5) For greater certainty,

  • (a) the requirements referred to in subsection (1) include requirements imposed on the Minister;

  • (b) the Minister may rely on a portion of a decision of, or a portion of any document or information produced by, a foreign regulatory authority; and

  • (c) nothing in this section is intended to limit the Minister’s ability to consider information, documents or other material obtained, directly or indirectly, from a foreign regulatory authority.

Reference to Regulations

Marginal note:Deeming

30.07 For the purposes of any provision of this Act, other than sections 30.01, 30.02, 30.05 and 30.06, any reference to regulations made under this Act is deemed to include orders made under section 30.01, 30.02, 30.05 or 30.06.

Interim Orders

Marginal note:Interim orders

• 30.1 (1) The Minister may make an interim order that contains any provision that may be contained in a regulation made under this Act if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment.

• Marginal note:Cessation of effect

  (2) An interim order has effect from the time that it is made but ceases to have effect on the earliest of

  • (a) 14 days after it is made, unless it is approved by the Governor in Council,

  • (b) the day on which it is repealed,

  • (c) the day on which a regulation made under this Act, that has the same effect as the interim order, comes into force, and

  • (d) one year after the interim order is made or any shorter period that may be specified in the interim order.

• Marginal note:Contravention of unpublished order

  (3) No person shall be convicted of an offence consisting of a contravention of an interim order that, at the time of the alleged contravention, had not been published in the Canada Gazette unless it is proved that, at the time of the alleged contravention, the person had been notified of the interim order or reasonable steps had been taken to bring the purport of the interim order to the notice of those persons likely to be affected by it.

• Marginal note:Exemption from Statutory Instruments Act

  (4) An interim order

  • (a) is exempt from the application of sections 3, 5 and 11 of the Statutory Instruments Act; and

  • (b) shall be published in the Canada Gazette within 23 days after it is made.

• Marginal note:Deeming

  (5) For the purpose of any provision of this Act other than this section and section 30.05, any reference to regulations made under this Act is deemed to include interim orders, and any reference to a regulation made under a specified provision of this Act is deemed to include a reference to the portion of an interim order containing any provision that may be contained in a regulation made under the specified provision.

• Marginal note:Tabling of order

  (6) A copy of each interim order must be tabled in each House of Parliament within 15 days after it is made.

• Marginal note:House not sitting

  (7) In order to comply with subsection (6), the interim order may be sent to the Clerk of the House if the House is not sitting.

Marketing Authorizations

Marginal note:Marketing authorization — representation

• 30.2 (1) Subject to regulations made under paragraph 30(1)(r), the Minister may issue a marketing authorization that exempts — if the conditions, if any, to which the marketing authorization is subject are met — an advertisement, or a representation on a label, with respect to a food from the application, in whole or in part, of subsection 3(1) or (2) or any provision of the regulations specified in the marketing authorization.

• Marginal note:Condition

  (2) The marketing authorization may be subject to any condition that the Minister considers appropriate.

Marginal note:Marketing authorization — food

• 30.3 (1) Subject to regulations made under paragraph 30(1)(r), the Minister may issue a marketing authorization that exempts — if the conditions to which the marketing authorization is subject are met — a food from the application, in whole or in part, of paragraph 4(1)(a) or (d) or section 6 or 6.1 or any provision of the regulations specified in the marketing authorization.

• Marginal note:Condition — amount

  (2) The marketing authorization may be subject to any condition relating to the amount of any substance that may or must be in or on the food, including

  • (a) the maximum residue limit of an agricultural chemical and its components or derivatives, singly or in any combination;

  • (b) the maximum residue limit of a veterinary drug and its metabolites, singly or in any combination;

  • (c) the maximum level of use for a food additive; and

  • (d) the minimum or maximum level, or both, of a vitamin, a mineral nutrient or an amino acid.

• Marginal note:Other conditions

  (3) The marketing authorization may be subject to any other condition that the Minister considers appropriate.

Marginal note:Classes

30.4 A marketing authorization may establish classes and distinguish among those classes.

Incorporation by Reference

Marginal note:Incorporation by reference

• 30.5 (1) The following instruments may incorporate by reference any document, regardless of its source, either as it exists on a particular date or as it is amended from time to time:

  • (a) a regulation made under this Act with respect to a food or therapeutic product;

  • (b) a marketing authorization; and

  • (c) an order made under subsection 30.63(1).

• Marginal note:Accessibility of incorporated documents

  (2) The Minister shall ensure that any document that is incorporated by reference is accessible.

• Marginal note:Defence

  (3) A person is not liable to be found guilty of an offence for any contravention in respect of which a document that is incorporated by reference is relevant unless, at the time of the alleged contravention, the document was accessible as required by subsection (2) or it was otherwise accessible to the person.

• Marginal note:No registration or publication

  (4) For greater certainty, a document that is incorporated by reference is not required to be transmitted for registration or published in the Canada Gazette by reason only that it is incorporated by reference.

Marginal note:Existing power not limited

30.6 For greater certainty, an express power in this Act to incorporate a document by reference does not limit the power that otherwise exists to incorporate a document by reference in a regulation made under this Act.

Fees

Marginal note:Fees

• 30.61 (1) The Minister may, by order, fix the following fees in relation to a drug, device, food or cosmetic:

  • (a) fees to be paid for a service, or the use of a facility, provided under this Act;

  • (b) fees to be paid in respect of regulatory processes or approvals provided under this Act; and

  • (c) fees to be paid in respect of products, rights and privileges provided under this Act.

• Marginal note:Amount not to exceed cost

  (2) A fee fixed under paragraph (1)(a) may not exceed the cost to Her Majesty in right of Canada of providing the service or the use of the facility.

• Marginal note:Aggregate amount not to exceed cost

  (3) Fees fixed under paragraph (1)(b) may not in the aggregate exceed the cost to Her Majesty in right of Canada in respect of providing the regulatory processes or approvals.

Marginal note:Consultation

30.62 Before making an order under subsection 30.61(1), the Minister shall consult with any persons that the Minister considers to be interested in the matter.

Marginal note:Remission of fees

• 30.63 (1) The Minister may, by order, remit all or part of any fee fixed under subsection 30.61(1) and the interest on it.

• Marginal note:Remission may be conditional

  (2) A remission granted under subsection (1) may be conditional.

• Marginal note:Conditional remission

  (3) If a remission granted under subsection (1) is conditional and the condition is not fulfilled, then the remission is cancelled and is deemed never to have been granted.