Food and Drugs Act

Marginal note:Regulations

• 30 (1) The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations

  • (a) declaring that any food or drug or class of food or drugs is adulterated if any prescribed substance or class of substances is present therein or has been added thereto or extracted or omitted therefrom;

  • (a.01) declaring that any drug is adulterated if the Minister believes that a prescribed substance contained in that drug presents a serious risk to the environment;

  • (a.1) respecting consultations in respect of orders referred to in section 2.4;

  • (b) respecting

    • (i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,

    • (ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,

    • (iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and

    • (iv) the use of any substance as an ingredient in any food, drug, cosmetic or device,

    to prevent the purchaser or consumer thereof from being deceived or misled in respect of the design, construction, performance, intended use, quantity, character, value, composition, merit or safety thereof, or to prevent injury to the health of the purchaser or consumer;

  • (b.01) respecting, for the purposes of managing risks to the environment, any of the following:

    • (i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,

    • (ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,

    • (iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and

    • (iv) the use of any substance as an ingredient in any food, drug, cosmetic or device;

  • (b.1) respecting the conduct of clinical trials;

  • (b.2) respecting the issuance of authorizations referred to in section 3.1 and the amendment, suspension and revocation of those authorizations;

  • (b.3) authorizing the Minister to impose terms and conditions on authorizations referred to in section 3.1, including existing authorizations, and to amend those terms and conditions;

  • (b.4) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in section 3.1, and to the imposition and amendment of terms and conditions referred to in paragraph (b.3), along with the reasons for those decisions, are publicly available;

  • (b.5) requiring holders of an authorization referred to in section 3.1, or former holders of such an authorization, to provide the Minister, after the clinical trial to which the authorization relates is completed or discontinued or, if the authorization is suspended or revoked, after the suspension or revocation, with safety information that the holders or former holders receive or become aware of about the drug, device or food for a special dietary purpose that is or was the subject of the clinical trial;

  • (c) prescribing standards of composition, strength, potency, purity, quality or other property of any article of food, drug, cosmetic or device;

  • (d) respecting the importation of food, drugs, cosmetics and devices — including any importation that is solely for the purpose of export — in order to ensure compliance with the provisions of this Act and the regulations;

  • (e) respecting the method of manufacture, preparation, preserving, packaging, storing and testing of any food, drug, cosmetic or device in the interest of, or for the prevention of injury to, the health of the purchaser or consumer or to manage risks to the environment;

  • (f) requiring persons that sell food, drugs, cosmetics or devices, or persons that import them solely for the purpose of export, to maintain any records, reports, electronic data or other documents that the Governor in Council considers necessary for the purposes of this Act;

  • (g) respecting the form and manner of the Minister’s indication under section 12, including the fees payable therefor, and prescribing what premises or what processes or conditions of manufacture, including qualifications of technical staff, shall or shall not be deemed to be suitable for the purposes of that section;

  • (h) requiring manufacturers of any drugs described in Schedule E to submit test portions of any batch of those drugs and respecting the form and manner of the Minister’s indication under section 13, including the fees payable therefor;

  • (h.01) respecting the provision to the Minister of evidence under subsection 16.3(2);

  • (h.1) respecting the establishment by the Minister of the list referred to in subsection 29.1(1), including amendments to it;

  • (i) respecting the powers, duties and functions of inspectors and analysts and the taking of samples;

  • (i.1) respecting the seizure, detention, forfeiture and disposition of articles under this Act;

  • (j) exempting, with or without conditions, any food, drug, cosmetic, device, person or activity from all or any of the provisions of this Act or the regulations;

  • (j.1) respecting orders referred to in sections 30.01, 30.02, 30.05 and 30.06;

  • (k) prescribing forms for the purposes of this Act and the regulations;

  • (k.1) respecting the time and manner in which information, notices and documents are to be provided or served under this Act;

  • (k.2) requiring persons to provide information to the Minister in respect of food, drugs, cosmetics or devices — or in respect of activities related to food, drugs, cosmetics or devices — in circumstances other than those provided for in this Act and authorizing the Minister to determine the information to be provided and the time and manner in which it is to be provided;

  • (l) providing for the analysis of food, drugs or cosmetics other than for the purposes of this Act and prescribing a tariff of fees to be paid for that analysis;

  • (l.1) respecting the assessment of the effect on the environment or on human life and health of the release into the environment of any food, drug, cosmetic or device, and the measures to take before importing or selling any such food, drug, cosmetic or device;

  • (m) adding anything to any of the schedules, other than to Schedule A or G, in the interest of, or for the prevention of injury to, the health of the purchaser or consumer, or deleting anything from any of the schedules, other than from Schedule A or G;

  • (n) respecting the distribution or the conditions of distribution of drugs as samples;

  • (o) respecting

    • (i) the method of manufacture, preparation, preserving, packing, labelling, storing and testing of any new drug, and

    • (ii) the sale or the conditions of sale of any new drug,

    and defining for the purposes of this Act the expression new drug;

  • (p) authorizing the advertising to the general public of contraceptive devices and drugs manufactured, sold or represented for use in the prevention of conception and prescribing the circumstances and conditions under which, and the persons by whom, those devices and drugs may be so advertised;

  • (q) defining agricultural chemical, food additive, mineral nutrient, veterinary drug and vitamin for the purposes of this Act;

  • (r) respecting marketing authorizations, including establishing the eligibility criteria for submitting an application for such authorizations or for amending such authorizations;

  • (s) respecting the implementation, in relation to any food, drug, cosmetic or device, of international agreements that affect them; and

  • (t) prescribing anything that by this Act is to be prescribed.

• Marginal note:Classes

  (1.1) A regulation made under this Act may establish classes and distinguish among those classes.

• Marginal note:Regulations — therapeutic products

  (1.2) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make regulations

  • (a) respecting the issuance of authorizations — including licences — that authorize, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment, suspension and revocation of such authorizations;

  • (b) authorizing the Minister to impose terms and conditions on authorizations referred to in paragraph (a), including existing authorizations, and to amend those terms and conditions;

  • (b.1) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in paragraph (a), and to the imposition and amendment of terms and conditions in respect of those authorizations, along with the reasons for those decisions, are publicly available;

  • (b.2) specifying provisions of the regulations that are excluded from the exemption provided for in section 21.94 or 21.96;

  • (c) requiring holders of a therapeutic product authorization that authorizes the import or sale of a therapeutic product for a clinical trial, or former holders of such an authorization, to provide the Minister, after the trial is completed or discontinued, or, if the authorization is suspended or revoked, after the suspension or revocation, with safety information that the holders or former holders receive or become aware of about the therapeutic product;

  • (c.1) [Repealed, 2019, c. 29, s. 172]

  • (d) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk of injury to human health, that the holders receive or become aware of and that is relevant to the safety of the therapeutic product to which the authorization relates, regarding

    • (i) risks that have been communicated outside Canada, and the manner of the communication,

    • (ii) changes that have taken place to labelling outside Canada, and

    • (iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada;

  • (d.01) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk to the environment, that the holders receive or become aware of and that is relevant to the therapeutic product to which the authorization relates, regarding

    • (i) risks that have been communicated outside Canada, and the manner of the communication,

    • (ii) changes that have taken place to labelling outside Canada, and

    • (iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada;

  • (d.1) specifying the business information obtained under this Act in relation to an authorization under paragraph (a) that is not confidential business information, or the circumstances in which business information obtained under this Act in relation to such an authorization ceases to be confidential business information;

  • (d.2) authorizing the Minister to disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, business information that, under regulations made under paragraph (d.1),

    • (i) is not confidential business information, or

    • (ii) has ceased to be confidential business information;

  • (e) respecting modifications of labels and modifications and replacements of packages referred to in sections 21.2 and 21.302;

  • (f) respecting the recall of a therapeutic product or the sale of a therapeutic product that is the subject of a recall;

  • (f.1) respecting assessments referred to in section 21.31, and the provision of the results of the assessments to the Minister;

  • (f.2) requiring the Minister to ensure that decisions with regard to the making of orders under section 21.31, along with the reasons for those decisions, are publicly available;

  • (f.3) respecting the compilation of information, the conducting of tests and studies and the monitoring that are referred to in paragraphs 21.32(a) and 21.33(a), and the provision to the Minister of the information or results referred to in paragraphs 21.32(b) and 21.33(b);

  • (g) prescribing anything that is to be prescribed under section 21.71;

  • (h) defining serious adverse drug reaction and medical device incident for the purposes of this Act;

  • (i) respecting the provision by health care institutions referred to in section 21.8 to the Minister of information referred to in that section; and

  • (j) prescribing anything that is to be prescribed under section 21.8.

• Marginal note:Consideration of existing information management systems

  (1.3) Before recommending to the Governor in Council that a regulation be made under paragraph (1.2)(i) or (j), the Minister shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens.

• Marginal note:Regulations — preventing or alleviating shortages

  (1.4) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of preventing shortages of therapeutic products or foods for a special dietary purpose in Canada or alleviating those shortages or their effects, in order to protect human health.

• Marginal note:Regulations — animal testing

  (1.5) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of preventing, in respect of cosmetics, the conduct of a test on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal, or preventing the purchaser or consumer of a cosmetic from being deceived or misled in respect of whether the cosmetic was tested on animals.

• Marginal note:Regulations respecting drugs manufactured outside Canada

  (2) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make such regulations governing, regulating or prohibiting

  • (a) the importation into Canada of any drug or class of drugs manufactured outside Canada, or

  • (b) the distribution or sale in Canada, or the offering, exposing or having in possession for sale in Canada, of any drug or class of drugs manufactured outside Canada,

  as the Governor in Council deems necessary for the protection of the public in relation to the safety and quality of any such drug or class of drugs.

• Marginal note:Regulations — Canada–United States–Mexico Agreement and WTO Agreement

  (3) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of implementing, in relation to drugs, Articles 20.48 and 20.49 of the Canada–United States–Mexico Agreement or paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the WTO Agreement.

• Marginal note:Definitions

  (4) In subsection (3),

  Canada–United States–Mexico Agreement

  Canada–United States–Mexico Agreement has the meaning assigned by the definition Agreement in section 2 of the Canada–United States–Mexico Agreement Implementation Act; (Accord Canada–États-Unis–Mexique)

  North American Free Trade Agreement

  North American Free Trade Agreement[Repealed, 2020, c. 1, s. 58]

  WTO Agreement

  WTO Agreement has the meaning given to the word Agreement by subsection 2(1) of the World Trade Organization Agreement Implementation Act. (Accord sur l’OMC)

• Marginal note:Regulations to implement General Council Decision

  (5) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of implementing the General Council Decision.

• Marginal note:Definitions

  (6) The definitions in this subsection apply in this subsection and in subsection (5).

  General Council

  General Council means the General Council of the WTO established by paragraph 2 of Article IV of the Agreement Establishing the World Trade Organization, signed at Marrakesh on April 15, 1994. (Conseil général)

  General Council Decision

  General Council Decision means the decision of the General Council of August 30, 2003 respecting Article 31 of the TRIPS Agreement, including the interpretation of that decision in the General Council Chairperson’s statement of that date. (décision du Conseil général)

  TRIPS Agreement

  TRIPS Agreement means the Agreement on Trade-Related Aspects of Intellectual Property Rights, being Annex 1C of the Agreement Establishing the World Trade Organization, signed at Marrakesh on April 15, 1994. (Accord sur les ADPIC)

  WTO

  WTO means the World Trade Organization established by Article I of the Agreement Establishing the World Trade Organization, signed at Marrakesh on April 15, 1994. (OMC)