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

Act current to 2016-11-21 and last amended on 2016-07-17. Previous Versions

Marginal note:Powers of inspectors
  •  (1) Subject to subsection (1.1), an inspector may at any reasonable time enter any place where the inspector believes on reasonable grounds any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged or stored, and may

    • (a) examine any such article and take samples thereof, and examine anything that the inspector believes on reasonable grounds is used or capable of being used for that manufacture, preparation, preservation, packaging or storing;

    • (a.1) enter any conveyance that the inspector believes on reasonable grounds is used to carry any article to which section 6 or 6.1 applies and examine any such article found therein and take samples thereof;

    • (b) open and examine any receptacle or package that the inspector believes on reasonable grounds contains any article to which this Act or the regulations apply;

    • (c) examine and make copies of, or extracts from, any books, documents or other records found in any place referred to in this subsection that the inspector believes on reasonable grounds contain any information relevant to the enforcement of this Act with respect to any article to which this Act or the regulations apply; and

    • (d) seize and detain for such time as may be necessary any article by means of or in relation to which the inspector believes on reasonable grounds any provision of this Act or the regulations has been contravened.

  • Marginal note:Warrant required to enter dwelling-house

    (1.1) Where any place mentioned in subsection (1) is a dwelling-house, an inspector may not enter that dwelling-house without the consent of the occupant except under the authority of a warrant issued under subsection (1.2).

  • Marginal note:Authority to issue warrant

    (1.2) Where on ex parte application a justice of the peace is satisfied by information on oath

    • (a) that the conditions for entry described in subsection (1) exist in relation to a dwelling-house,

    • (b) that entry to the dwelling-house is necessary for any purpose relating to the administration or enforcement of this Act, and

    • (c) that entry to the dwelling-house has been refused or that there are reasonable grounds for believing that entry thereto will be refused,

    the justice of the peace may issue a warrant under his hand authorizing the inspector named therein to enter that dwelling-house subject to such conditions as may be specified in the warrant.

  • Marginal note:Use of force

    (1.3) In executing a warrant issued under subsection (1.2), the inspector named therein shall not use force unless the inspector is accompanied by a peace officer and the use of force has been specifically authorized in the warrant.

  • Definition of article to which this Act or the regulations apply

    (2) In subsection (1), article to which this Act or the regulations apply includes

    • (a) any food, drug, cosmetic or device;

    • (b) anything used for the manufacture, preparation, preservation, packaging or storing thereof; and

    • (c) any labelling or advertising material.

  • Marginal note:Assistance and information to be given inspector

    (3) The owner or person in charge of a place entered by an inspector pursuant to subsection (1) and every person found therein shall give the inspector all reasonable assistance and furnish the inspector with any information he may reasonably require.

  • R.S., 1985, c. F-27, s. 23;
  • R.S., 1985, c. 31 (1st Supp.), s. 11, c. 27 (3rd Supp.), s. 2.
Marginal note:Obstruction and false statements
  •  (1) No person shall obstruct or hinder, or knowingly make any false or misleading statement either orally or in writing to, an inspector while the inspector is engaged in carrying out his duties or functions under this Act or the regulations.

  • Marginal note:Interference

    (2) Except with the authority of an inspector, no person shall remove, alter or interfere in any way with anything seized under this Part.

  • R.S., c. F-27, ss. 22, 37.
Marginal note:Storage and removal

 Any article seized under this Part may, at the option of an inspector, be kept or stored in the building or place where it was seized or, at the direction of an inspector, the article may be removed to any other proper place.

  • R.S., c. F-27, ss. 22, 37.
Marginal note:Release of seized articles

 An inspector who has seized any article under this Part shall release it when he is satisfied that all the provisions of this Act and the regulations with respect thereto have been complied with.

  • R.S., c. F-27, ss. 23, 37.
Marginal note:Destruction with consent
  •  (1) Where an inspector has seized an article under this Part and its owner or the person in whose possession the article was at the time of seizure consents to its destruction, the article is thereupon forfeited to Her Majesty and may be destroyed or otherwise disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct.

  • Marginal note:Forfeiture

    (2) Where a person has been convicted of a contravention of this Act or the regulations, the court or judge may order that any article by means of or in relation to which the offence was committed, and any thing of a similar nature belonging to or in the possession of the person or found with the article, be forfeited. On the making of the order, the article and thing are forfeited to Her Majesty and may be disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct.

  • Marginal note:Order for forfeiture on application of inspector

    (3) Without prejudice to subsection (2), a judge of a superior court of the province in which any article is seized under this Part may, on the application of an inspector and on such notice to such persons as the judge directs, order that the article and any thing of a similar nature found with it be forfeited to Her Majesty, if the judge finds, after making such inquiry as the judge considers necessary, that the article is one by means of or in relation to which any of the provisions of this Act or the regulations have been contravened. On the making of the order, the article or thing may be disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct.

  • R.S., 1985, c. F-27, s. 27;
  • 1992, c. 1, s. 145(F);
  • 1994, c. 38, s. 19;
  • 1995, c. 1, s. 62;
  • 1996, c. 8, s. 23.2;
  • 1997, c. 6, s. 64.

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
  • 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 — 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 referred to in paragraph (b), along with the reasons for those decisions, are publicly available;

    • (c) requiring holders of a therapeutic product authorization that authorizes the import or sale of a therapeutic product for a clinical trial or investigational test involving human subjects, or former holders of such an authorization, to provide the Minister, after the trial or test 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) defining clinical trial and investigational test for the purposes of this Act;

    • (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.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 section 21.2;

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

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

  • 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 — North American Free Trade 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, 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

    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; (Accord de libre-échange nord-américain)

    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)

  • 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;
  • 2014, c. 24, s. 6.
 
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