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

Act current to 2014-09-15 and last amended on 2013-06-19. Previous Versions

Analysis

Marginal note:Analysts

 The Minister may designate any person as an analyst for the purpose of the enforcement of this Act.

  • 1980-81-82-83, c. 47, s. 19.
Marginal note:Analysis and examination
  •  (1) An inspector may submit to an analyst, for analysis or examination, any article seized by the inspector, any sample therefrom or any sample taken by the inspector.

  • Marginal note:Certificate or report

    (2) An analyst who has made an analysis or examination may issue a certificate or report setting out the results of the analysis or examination.

  • R.S., c. F-27, s. 24.

Power of the Minister

Marginal note:List
  •  (1) Subject to the regulations, the Minister may establish a list that sets out prescription drugs, classes of prescription drugs or both.

  • Marginal note:Statutory Instruments Act

    (2) The list is not a regulation within the meaning of the Statutory Instruments Act.

  • 2012, c. 19, s. 413.

Incorporation by Reference

Marginal note:Incorporation by reference
  •  (1) A regulation made under this Act may incorporate by reference the list established under subsection 29.1(1), either as it exists on a particular date or as it is amended from time to time.

  • Marginal note:Accessibility of incorporated list

    (2) The Minister shall ensure that the list that is incorporated by reference in the regulation 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 the list that is incorporated by reference in the regulation is relevant unless, at the time of the alleged contravention, the list was accessible as required by subsection (2) or it was otherwise accessible to the person.

  • 2012, c. 19, s. 413.

Regulations

Marginal note:Regulations
  •  (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;

    • (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;

    • (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 foods, drugs, cosmetics and devices in order to ensure compliance with this Act and the regulations;

    • (e) respecting the method of manufacture, preparation, preserving, packing, 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;

    • (f) requiring persons who sell food, drugs, cosmetics or devices to maintain such books and records as the Governor in Council considers necessary for the proper enforcement and administration of this Act and the regulations;

    • (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.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 and duties of inspectors and analysts and the taking of samples and the seizure, detention, forfeiture and disposition of articles;

    • (j) exempting any food, drug, cosmetic or device from all or any of the provisions of this Act and prescribing the conditions of the exemption;

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

    • (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, in the interest of, or for the prevention of injury to, the health of the purchaser or consumer, or deleting anything therefrom;

    • (n) respecting the distribution or the conditions of distribution of samples of any drug;

    • (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; and

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

  • Marginal note:Classes

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

  • Marginal note:Regulations respecting drugs manufactured outside Canada

    (2) Without limiting or restricting the authority conferred by any other provisions of this Act or any Part thereof for carrying into effect the purposes and provisions of this Act or any Part thereof, 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 re the North American Free Trade Agreement and WTO Agreement

    (3) Without limiting or restricting the authority conferred by any other provisions of this Act or any Part thereof for carrying into effect the purposes and provisions of this Act or any Part thereof, the Governor in Council may make such regulations as the Governor in Council deems necessary for the purpose of implementing, in relation to drugs, Article 1711 of the North American Free Trade 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),

    “North American Free Trade Agreement”

    « Accord de libre-échange nord-américain »

    “North American Free Trade Agreement” has the meaning given to the word “Agreement” by subsection 2(1) of the North American Free Trade Agreement Implementation Act;

    “WTO Agreement”

    « Accord sur l’OMC »

    “WTO Agreement” has the meaning given to the word “Agreement” by subsection 2(1) of the World Trade Organization Agreement Implementation Act.

  • Marginal note:Regulations to implement the General Council Decision

    (5) Without limiting or restricting the authority conferred by any other provisions of this Act or any of its Parts for carrying into effect the purposes and provisions of this Act or any of its Parts, 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”

    « Conseil général »

    “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.

    “General Council Decision”

    « décision du Conseil général »

    “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.

    “TRIPS Agreement”

    « Accord sur les ADPIC »

    “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.

    “WTO”

    « OMC »

    “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.

  • R.S., 1985, c. F-27, s. 30;
  • 1993, c. 44, s. 158;
  • 1994, c. 47, s. 117;
  • 1999, c. 33, s. 347;
  • 2004, c. 23, s. 2;
  • 2005, c. 42, s. 2;
  • 2012, c. 19, ss. 414, 415.