Short Title

Marginal note:Short title

1 This Act may be cited as the Food and Drugs Act.

Interpretation

Marginal note:Definitions

2 In this Act,

advertisement

advertisement includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device; (publicité ou annonce)

analyst

analyst means an individual designated as an analyst for the purposes of this Act under section 28 or under section 13 of the Canadian Food Inspection Agency Act; (analyste)

confidential business information

confidential business information, in respect of a person to whose business or affairs the information relates, means — subject to the regulations — business information

• (a) that is not publicly available,

• (b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and

• (c) that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors; (renseignements commerciaux confidentiels)

contraceptive device

contraceptive device means any instrument, apparatus, contrivance or substance other than a drug, that is manufactured, sold or represented for use in the prevention of conception; (moyen anticonceptionnel)

cosmetic

cosmetic includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes; (cosmétique)

Department

Department means the Department of Health; (ministère)

device

device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in

• (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,

• (b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,

• (c) diagnosing pregnancy in human beings or animals,

• (d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or

• (e) preventing conception in human beings or animals;

however, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal; (instrument)

drug

drug includes any substance or mixture of substances manufactured, sold or represented for use in

• (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

• (b) restoring, correcting or modifying organic functions in human beings or animals, or

• (c) disinfection in premises in which food is manufactured, prepared or kept; (drogue)

food

food includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever; (aliment)

inspector

inspector means an individual designated as an inspector for the purposes of this Act under subsection 22(1) or under section 13 of the Canadian Food Inspection Agency Act; (inspecteur)

label

label includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package; (étiquette)

Minister

Minister means the Minister of Health; (ministre)

package

package includes any thing in which any food, drug, cosmetic or device is wholly or partly contained, placed or packed; (emballage)

person

person means an individual or an organization as defined in section 2 of the Criminal Code; (personne)

prescribed

prescribed means prescribed by the regulations; (Version anglaise seulement)

sell

sell includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration; (vente)

therapeutic product

therapeutic product means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations; (produit thérapeutique)

therapeutic product authorization

therapeutic product authorization means an authorization — including a licence and a suspended authorization or licence — that is issued under the regulations and that authorizes, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product; (autorisation relative à un produit thérapeutique)

unsanitary conditions

unsanitary conditions means such conditions or circumstances as might contaminate with dirt or filth, or render injurious to health, a food, drug or cosmetic. (conditions non hygiéniques)

Marginal note:Non-corrective contact lenses

2.1 For the purposes of this Act, a non-corrective contact lens is deemed to be a device.

PART IFoods, Drugs, Cosmetics and Devices

General

Marginal note:Prohibited advertising

• 3 (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

• Marginal note:Prohibited label or advertisement where sale made

  (2) No person shall sell any food, drug, cosmetic or device

  • (a) that is represented by label, or

  • (b) that the person advertises to the general public

  as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

• Marginal note:Unauthorized advertising of contraceptive device prohibited

  (3) Except as authorized by regulation, no person shall advertise to the general public any contraceptive device or any drug manufactured, sold or represented for use in the prevention of conception.

Food

Marginal note:Prohibited sales of food

• 4 (1) No person shall sell an article of food that

  • (a) has in or on it any poisonous or harmful substance;

  • (b) is unfit for human consumption;

  • (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;

  • (d) is adulterated; or

  • (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

• Marginal note:Exemption

  (2) A food does not have a poisonous or harmful substance in or on it for the purposes of paragraph (1)(a) — or is not adulterated for the purposes of paragraph (1)(d) — by reason only that it has in or on it a pest control product as defined in subsection 2(1) of the Pest Control Products Act, or any of its components or derivatives, if the amount of the pest control product or the components or derivatives in or on the food being sold does not exceed the maximum residue limit specified under section 9 or 10 of that Act.

Marginal note:Deception, etc., regarding food

• 5 (1) No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

• Marginal note:Food labelled or packaged in contravention of regulations

  (2) An article of food that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).

Marginal note:Importation and interprovincial movement of food

• 6 (1) Where a standard for a food has been prescribed, no person shall

  • (a) import into Canada,

  • (b) send, convey or receive for conveyance from one province to another, or

  • (c) have in possession for the purpose of sending or conveying from one province to another

  any article that is intended for sale and that is likely to be mistaken for that food unless the article complies with the prescribed standard.

• Marginal note:Not applicable to carriers

  (2) Paragraphs (1)(b) and (c) do not apply to an operator of a conveyance that is used to carry an article or to a carrier of an article whose sole concern, in respect of the article, is the conveyance of the article unless the operator or carrier could, with reasonable diligence, have ascertained that the conveying or receiving for conveyance of the article or the possession of the article for the purpose of conveyance would be in contravention of subsection (1).

• Marginal note:Labelling, etc., of food that is imported or moved interprovincially

  (3) Where a standard for a food has been prescribed, no person shall label, package, sell or advertise any article that

  • (a) has been imported into Canada,

  • (b) has been sent or conveyed from one province to another, or

  • (c) is intended to be sent or conveyed from one province to another

  in such a manner that it is likely to be mistaken for that food unless the article complies with the prescribed standard.

Marginal note:Governor in Council may identify standard or portion thereof

• 6.1 (1) The Governor in Council may, by regulation, identify a standard prescribed for a food, or any portion of the standard, as being necessary to prevent injury to the health of the consumer or purchaser of the food.

• Marginal note:Where standard or portion thereof is identified

  (2) Where a standard or any portion of a standard prescribed for a food is identified by the Governor in Council pursuant to subsection (1), no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that food unless the article complies with the standard or portion of a standard so identified.

Marginal note:Unsanitary manufacture, etc., of food

7 No person shall manufacture, prepare, preserve, package or store for sale any food under unsanitary conditions.

Drugs

Marginal note:Prohibited sales of drugs

8 No person shall sell any drug that

• (a) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions; or

• (b) is adulterated.

Marginal note:Deception, etc., regarding drugs

• 9 (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

• Marginal note:Drugs labelled or packaged in contravention of regulations

  (2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).

Marginal note:Where standard prescribed for drug

• 10 (1) Where a standard has been prescribed for a drug, no person shall label, package, sell or advertise any substance in such a manner that it is likely to be mistaken for that drug, unless the substance complies with the prescribed standard.

• Marginal note:Trade standards

  (2) Where a standard has not been prescribed for a drug, but a standard for the drug is contained in any publication referred to in Schedule B, no person shall label, package, sell or advertise any substance in such a manner that it is likely to be mistaken for that drug, unless the substance complies with the standard.

• Marginal note:Where no prescribed or trade standard

  (3) Where a standard for a drug has not been prescribed and no standard for the drug is contained in any publication referred to in Schedule B, no person shall sell the drug unless

  • (a) it is in accordance with the professed standard under which it is sold; and

  • (b) it does not resemble, in a manner likely to deceive, any drug for which a standard has been prescribed or is contained in any publication referred to in Schedule B.

Marginal note:Unsanitary manufacture, etc., of drug

11 No person shall manufacture, prepare, preserve, package or store for sale any drug under unsanitary conditions.

Marginal note:Drugs not to be sold unless safe manufacture indicated

12 No person shall sell any drug described in Schedule C or D unless the Minister has, in prescribed form and manner, indicated that the premises in which the drug was manufactured and the process and conditions of manufacture therein are suitable to ensure that the drug will not be unsafe for use.

Marginal note:Drugs not to be sold unless safe batch indicated

13 No person shall sell any drug described in Schedule E unless the Minister has, in prescribed form and manner, indicated that the batch from which the drug was taken is not unsafe for use.

Marginal note:Samples

• 14 (1) No person shall distribute or cause to be distributed any drug as a sample.

• Marginal note:Exception

  (2) Subsection (1) does not apply to the distribution, under prescribed conditions, of samples of drugs to physicians, dentists, veterinary surgeons or pharmacists.

Marginal note:Schedule F drugs not to be sold

15 No person shall sell any drug described in Schedule F.

Cosmetics

Marginal note:Prohibited sales of cosmetics

16 No person shall sell any cosmetic that

• (a) has in or on it any substance that may cause injury to the health of the user when the cosmetic is used,

  • (i) according to the directions on the label or accompanying the cosmetic, or

  • (ii) for such purposes and by such methods of use as are customary or usual therefor;

• (b) consists in whole or in part of any filthy or decomposed substance or of any foreign matter; or

• (c) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

Marginal note:Where standard prescribed for cosmetic

17 Where a standard has been prescribed for a cosmetic, no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that cosmetic, unless the article complies with the prescribed standard.

Marginal note:Unsanitary conditions

18 No person shall manufacture, prepare, preserve, package or store for sale any cosmetic under unsanitary conditions.

Devices

Marginal note:Prohibited sales of devices

19 No person shall sell any device that, when used according to directions or under such conditions as are customary or usual, may cause injury to the health of the purchaser or user thereof.

Marginal note:Deception, etc., regarding devices

• 20 (1) No person shall label, package, treat, process, sell or advertise any device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, quantity, character, value, composition, merit or safety.

• Marginal note:Devices labelled or packaged in contravention of regulations

  (2) A device that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).

Marginal note:Where standard prescribed for device

21 Where a standard has been prescribed for a device, no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that device, unless the article complies with the prescribed standard.

Therapeutic Products

Marginal note:Power to require information — serious risk

• 21.1 (1) If the Minister believes that a therapeutic product may present a serious risk of injury to human health, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk.

• Marginal note:Disclosure —  serious risk

  (2) The Minister may disclose confidential business information about a therapeutic prod­uct without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk of injury to human health.

• Marginal note:Disclosure —  health or safety

  (3) The Minister may disclose confidential business information about a therapeutic prod­uct without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to

  • (a) a government;

  • (b) a person from whom the Minister seeks advice; or

  • (c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

• Definition of government

  (4) In this section, government means any of the following or their institutions:

  • (a) the federal government;

  • (b) a corporation named in Schedule III to the Financial Administration Act;

  • (c) a provincial government or a public body established under an Act of the legislature of a province;

  • (d) an aboriginal government as defined in subsection 13(3) of the Access to Information Act;

  • (e) a government of a foreign state or of a subdivision of a foreign state; or

  • (f) an international organization of states.

Marginal note:Modification or replacement — labelling or packaging

21.2 The Minister may, if he or she believes that doing so is necessary to prevent injury to health, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package.

Marginal note:Minister’s powers — risk of injury to health

• 21.3 (1) If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to

  • (a) recall the product; or

  • (b) send the product, or cause it to be sent, to a place specified in the order.

• Marginal note:Recall order — corrective action

  (2) For greater certainty, if the Minister makes an order under paragraph (1)(a) and believes that corrective action is an effective means of dealing with the risk, the order may require the person who sells the product to, instead of requesting the product’s return, request the product’s owner or user to allow corrective action to be taken in respect of the product and then take that corrective action, or cause it to be taken, if the request is accepted.

• Marginal note:Prohibition — selling

  (3) Subject to subsection (5), no person shall sell a therapeutic product that the Minister orders them, or another person, to recall.

• Marginal note:Power to authorize sale

  (4) The Minister may authorize a person to sell a therapeutic product, with or without conditions, even if the Minister has ordered them, or another person, to recall it.

• Marginal note:Exception

  (5) A person does not contravene subsection (3) if they sell a therapeutic product that they have been authorized under subsection (4) to sell, provided that they sell it in accordance with any conditions that the Minister establishes.

• Marginal note:Contravention of unpublished order

  (6) No person shall be convicted of an offence for the contravention of subsection (3) unless it is proved that, at the time of the alleged contravention, the person had been notified of the recall order or reasonable steps had been taken to bring the purport of the recall order to the notice of those persons likely to be affected by it.

Marginal note:Statutory Instruments Act

• 21.4 (1) For greater certainty, orders made under any of sections 21.1 to 21.3 are not statutory instruments within the meaning of the Statutory Instruments Act.

• Marginal note:Availability of orders

  (2) The Minister shall ensure that any order made under any of sections 21.1 to 21.3 is publicly available.

Marginal note:Injunction

• 21.5 (1) If, on the application of the Minister, it appears to a court of competent jurisdiction that a person has done, is about to do or is likely to do anything that constitutes or is directed toward the commission of an offence under this Act in respect of a therapeutic product, the court may issue an injunction ordering the person, who is to be named in the application, to

  • (a) refrain from doing anything that it appears to the court may constitute or be directed toward the commission of the offence; or

  • (b) do anything that it appears to the court may prevent the commission of the offence.

• Marginal note:Notice

  (2) No injunction is to be issued under subsection (1) unless 48 hours’ notice is served on the party or parties who are named in the application or unless the urgency of the situation is such that service of notice would not be in the public interest.

Marginal note:False or misleading information — therapeutic products

21.6 No person shall knowingly make a false or misleading statement to the Minister  —  or knowingly provide him or her with false or misleading information  —  in connection with any matter under this Act concerning a therapeutic product.

Marginal note:Terms and conditions of authorizations

21.7 The holder of a therapeutic product authorization shall comply with the terms and conditions of the authorization that are imposed under regulations made under paragraph 30(1.2)(b).

Marginal note:Clinical trials and investigational tests

21.71 The holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) shall ensure that prescribed information concerning the clinical trial or investigational test is made public within the prescribed time and in the prescribed manner.

PART IIAdministration and Enforcement

Inspection, Seizure and Forfeiture

Marginal note:Inspectors

• 22 (1) For the purposes of the administration and enforcement of this Act, the Minister may designate individuals or classes of individuals as inspectors to exercise powers or perform duties or functions in relation to any matter referred to in the designation.

• Marginal note:Certificate to be produced

  (2) An inspector shall be given a certificate in a form established by the Minister or the President of the Canadian Food Inspection Agency attesting to the inspector’s designation and, on entering any place pursuant to subsection 23(1), an inspector shall, if so required, produce the certificate to the person in charge of that place.

Marginal note:Powers of inspectors

• 23 (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.

Marginal note:Obstruction and false statements

• 24 (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.

Marginal note:Storage, movement and disposal

25 An inspector may, in respect of any article seized under this Part,

• (a) on notice to its owner or the person having possession, care or control of it at the time of its seizure, store it or move it at the expense of the person to whom the notice is given;

• (b) order its owner or the person having possession, care or control of it at the time of its seizure to store it or move it at the expense of the person being so ordered; or

• (c) order its owner or the person having possession, care or control of it at the time of its seizure to dispose of it at the expense of the person being so ordered — or, on notice to its owner or the person having possession, care or control of it at the time of its seizure, dispose of it at the expense of the person to whom the notice is given — if

  • (i) the article is perishable, or

  • (ii) the inspector is of the opinion that the article presents a risk of injury to health or safety and that its disposal is necessary to respond to the risk.

Marginal note:Release of seized articles

26 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.

Marginal note:Unclaimed seized articles

• 26.1 (1) An article seized under this Part is, at the election of the Minister or the Minister of Agriculture and Agri-Food, forfeited to Her Majesty in right of Canada if

  • (a) within 60 days after the seizure, no person is identified in accordance with the regulations, if any, as its owner or as the person entitled to possess it; or

  • (b) its owner or the person having possession, care or control of it at the time of its seizure does not claim it within 60 days after the day on which they are notified that an inspector has released it.

• Marginal note:Disposal

  (2) A seized article that is forfeited under subsection (1) may be disposed of, as the Minister or the Minister of Agriculture and Agri-Food may direct, at the expense of its owner or the person having possession, care or control of it at the time of its seizure.

Marginal note:Forfeiture with consent

• 27 (1) If an inspector has seized an article under this Part and its owner or the person having possession, care or control of it at the time of its seizure consents to its forfeiture, the article is forfeited to Her Majesty in right of Canada and may be disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct, at the expense of its owner or the person having possession, care or control of the article at the time of its seizure.

• Marginal note:Forfeiture — offence

  (2) If a person has been convicted of a contravention of this Act or the regulations, the court or judge may, in addition to any punishment imposed, 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, care or control 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 in right of Canada and may be disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct, at the expense of the person who has been convicted.

• 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 any notice to those persons that the judge directs, order that the article and any thing of a similar nature found with it be forfeited to Her Majesty in right of Canada, if the judge finds, after making any inquiry that the judge considers necessary, that the article is one by means of or in relation to which a provision of this Act or the regulations has 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, at the expense of the owner of the article or the person having possession, care or control of it at the time of its seizure.

Removal, Forfeiture or Destruction of Unlawful Imports

Marginal note:Unlawful imports

• 27.1 (1) An inspector who has reasonable grounds to believe that an imported food, drug, cosmetic or device does not meet the requirements of the regulations or was imported in contravention of a provision of this Act or the regulations may decide whether to give the owner or importer, or the person having possession, care or control of the food, drug, cosmetic or device, the opportunity to take a measure in respect of it.

• Marginal note:Factors

  (2) In making a decision under subsection (1), the inspector shall consider, among other factors:

  • (a) whether the food, drug, cosmetic or device presents a risk of injury to health or safety; and

  • (b) any other prescribed factors.

• Marginal note:Duty of inspector

  (3) If the inspector decides under subsection (1) not to give the owner or importer, or the person having possession, care or control of the food, drug, cosmetic or device the opportunity to take a measure in respect of it, the inspector shall exercise, in respect of the food, drug, cosmetic or device, any of the powers conferred by the provisions of this Act, other than this section, or of the regulations.

• Marginal note:Measures that may be taken and notice

  (4) However, if the inspector decides under subsection (1) to give the owner or importer, or the person having possession, care or control of the food, drug, cosmetic or device the opportunity to take a measure in respect of it, the inspector, or any other inspector who is informed of the decision, shall decide whether the owner or importer, or the person having possession, care or control of it may remove it from Canada at their expense, consent to its forfeiture or take either of these measures, and shall notify or cause to be notified the owner or importer, or the person having possession, care or control of the food, drug, cosmetic or device that they may take that measure within the period specified by the inspector or other inspector, as the case may be.

• Marginal note:Forfeiture

  (5) If a person is notified under subsection (4) that they may consent to the forfeiture of the food, drug, cosmetic or device and the person consents to its forfeiture, the food, drug, cosmetic or device is forfeited to Her Majesty in right of Canada and may be disposed of, as the Minister may direct, at the person’s expense.

Marginal note:Removal or destruction

• 27.2 (1) An inspector who has reasonable grounds to believe that an imported food, drug, cosmetic or device does not meet the requirements of the regulations or was imported in contravention of a provision of this Act or the regulations may, by notice, whether the food, drug, cosmetic or device is seized or not, order its owner or importer, or the person having possession, care or control of it, to remove it from Canada at their expense or, if removal is not possible, to destroy it at their expense.

• Marginal note:Notice

  (2) The notice must be delivered personally to the owner or importer of the food, drug, cosmetic or device, or the person having possession, care or control of it, or sent to the owner, importer or person by any method that provides proof of delivery or by any prescribed method.

• Marginal note:Forfeiture

  (3) If the food, drug, cosmetic or device is not removed from Canada, or destroyed, within the period specified in the notice — or, if no period is specified, within 90 days after the day on which the notice was delivered or sent — it is, despite section 26, forfeited to Her Majesty in right of Canada and may be disposed of, as the Minister may direct, at the expense of the person to whom the notice was delivered or sent.

• Marginal note:Suspension of application of subsection (3)

  (4) An inspector may, for the period specified by the inspector, suspend the application of subsection (3) if the inspector is satisfied that

  • (a) the food, drug, cosmetic or device does not present a risk of injury to health;

  • (b) the food, drug, cosmetic or device will not be sold within that period;

  • (c) the measures that should have been taken for the food, drug, cosmetic or device not to have been imported in contravention of a provision of this Act or the regulations will be taken within that period; and

  • (d) if the food, drug, cosmetic or device does not meet the requirements of the regulations, it will be brought into compliance with those requirements within that period.

• Marginal note:Cancellation

  (5) An inspector may cancel the notice if the inspector is satisfied that

  • (a) the food, drug, cosmetic or device does not present a risk of injury to health;

  • (b) the food, drug, cosmetic or device has not been sold within the period referred to in subsection (6);

  • (c) the measures referred to in paragraph (4)(c) were taken within that period; and

  • (d) if the food, drug, cosmetic or device did not meet the requirements of the regulations when it was imported, it was brought into compliance with those requirements within that period.

• Marginal note:Period

  (6) The period for the purposes of subsection (5) is

  • (a) if the application of subsection (3) was suspended under subsection (4), the period of the suspension; and

  • (b) if the application of subsection (3) was not suspended, the period specified in the notice or, if no period was specified, the period of 90 days after the day on which the notice was delivered or sent.

• Marginal note:Non-application of Statutory Instruments Act

  (7) The Statutory Instruments Act does not apply to the notice.

Analysis

Marginal note:Analysts

28 The Minister may designate any individual as an analyst for the purposes of the administration and enforcement of this Act.

Marginal note:Analysis and examination

• 29 (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:Costs

  (1.1) The analysis or examination of any article seized, or of any sample, shall be at the expense of

  • (a) in respect of an article seized or a sample taken from it, the owner of the article or the person having possession, care or control of the article at the time of its seizure; or

  • (b) in respect of a sample taken by the inspector, the owner of the article from which the sample was taken or the person having possession, care or control of it at the time the sample was taken.

• 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.

Power of the Minister

Marginal note:List

• 29.1 (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.

Incorporation by Reference

Marginal note:Incorporation by reference

• 29.2 (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.

Regulations

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;

  • (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 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, 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, or persons who import them solely for the purpose of export, to maintain any books and records 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.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;

  • (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;

  • (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;

  • (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 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)

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, 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) A regulation made under this Act with respect to a food or therapeutic product and a marketing authorization 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.

• Marginal note:Accessibility of incorporated documents

  (2) The Minister shall ensure that any document that is incorporated by reference in the regulation or marketing authorization 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 in the regulation or marketing authorization 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 in the regulation or marketing authorization 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.

Costs

Marginal note:Recovery

• 30.7 (1) Her Majesty in right of Canada may recover, as a debt due to Her Majesty in right of Canada, any costs incurred by Her Majesty in right of Canada in relation to anything required or authorized under this Act, including the inspection of a place or the analysis, examination, storage, movement, seizure, detention, forfeiture, disposal or release of an article.

• Marginal note:Time limit

  (2) Proceedings to recover a debt due to Her Majesty in right of Canada under subsection (1) shall not be commenced later than five years after the debt became payable.

Marginal note:Certificate of default

• 30.8 (1) Any debt that may be recovered under subsection 30.7(1) in respect of which there is a default of payment, or the part of any such debt that has not been paid, may be certified by the Minister.

• Marginal note:Judgment

  (2) On production to the Federal Court, a certificate made under subsection (1) shall be registered in that Court and, when registered, has the same force and effect, and all proceedings may be taken on the certificate, as if it were a judgment obtained in that Court for a debt of the amount specified in the certificate and all reasonable costs and charges attendant in the registration of the certificate.

Offences and Punishment

Marginal note:Contravention of Act or regulations

31 Subject to sections 31.1, 31.2 and 31.4, every person who contravenes any of the provisions of this Act or of the regulations, or fails to do anything the person was ordered to do by an inspector under section 25 or 27.2, is guilty of an offence and liable

• (a) on summary conviction for a first offence to a fine not exceeding five hundred dollars or to imprisonment for a term not exceeding three months or to both and, for a subsequent offence, to a fine not exceeding one thousand dollars or to imprisonment for a term not exceeding six months or to both; and

• (b) on conviction on indictment to a fine not exceeding five thousand dollars or to imprisonment for a term not exceeding three years or to both.

Marginal note:Offences relating to food

31.1 Every person who contravenes any provision of this Act or the regulations, as it relates to food, is guilty of an offence and liable

• (a) on summary conviction, to a fine not exceeding $50,000 or to imprisonment for a term not exceeding six months or to both; or

• (b) on conviction by indictment, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding three years or to both.

Marginal note:Offences relating to therapeutic products

31.2 Subject to section 31.4, every person who contravenes any provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.3 is guilty of an offence and liable

• (a) on conviction by indictment, to a fine not exceeding $5,000,000 or to imprisonment for a term not exceeding two years or to both; and

• (b) on summary conviction, for a first offence, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding six months or to both and, for a subsequent offence, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding 18 months or to both.

Marginal note:Due diligence

31.3 Due diligence is a defence in a prosecution for an offence under this Act, other than an offence under section 31.4.

Marginal note:Offences — section 21.6 and serious risk

31.4 A person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.3 is guilty of an offence and liable

• (a) on conviction on indictment, to a fine the amount of which is at the discretion of the court or to imprisonment for a term not exceeding five years or to both; and

• (b) on summary conviction, for a first offence, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding 18 months or to both and, for a subsequent offence, to a fine not exceeding $1,000,000 or to imprisonment for a term not exceeding two years or to both.

Marginal note:Sentencing considerations

31.5 A court that imposes a sentence for an offence under section 31.2 or 31.4 shall take into account, in addition to any other principles that it is required to consider, the following factors:

• (a) the harm or risk of harm caused by the commission of the offence; and

• (b) the vulnerability of consumers of the therapeutic product.

Marginal note:Parties to offence

31.6 If a person other than an individual commits an offence under section 31.2, or commits an offence under section 31.4 by reason of contravening section 21.6, then any of the person’s directors, officers or agents or mandataries who directs, authorizes, assents to or acquiesces or participates in the commission of the offence is a party to the offence and is liable on conviction to the punishment provided for by this Act, even if the person is not prosecuted for the offence.

Marginal note:Continuing offence

31.7 If an offence under section 31.2 or 31.4 is committed or continued on more than one day, it constitutes a separate offence for each day on which it is committed or continued.

Marginal note:Limitation period

• 32 (1) A prosecution for a summary conviction offence under this Act may be instituted at any time within two years after the time the subject-matter of the prosecution becomes known to the Minister or, in the case of a contravention of a provision of the Act that relates to food, to the Minister of Agriculture and Agri-Food.

• Marginal note:Minister’s certificate

  (2) A document purporting to have been issued by the Minister referred to in subsection (1), certifying the day on which the subject-matter of any prosecution became known to the Minister, is admissible in evidence without proof of the signature or official character of the person appearing to have signed the document and is evidence of the matters asserted in it.

Marginal note:Venue

33 A prosecution for a contravention of this Act or the regulations may be instituted, heard, tried or determined in the place in which the offence was committed or the subject-matter of the prosecution arose or in any place in which the accused is apprehended or happens to be.

Marginal note:Want of knowledge

• 34 (1) Subject to subsection (2), in a prosecution for the sale of any article in contravention of this Act, except Parts III and IV, or of the regulations made under this Part, if the accused proves to the satisfaction of the court or judge that

  • (a) the accused purchased the article from another person in packaged form and sold it in the same package and in the same condition the article was in at the time it was so purchased, and

  • (b) that the accused could not with reasonable diligence have ascertained that the sale of the article would be in contravention of this Act or the regulations,

  the accused shall be acquitted.

• Marginal note:Notice of reliance on want of knowledge

  (2) Subsection (1) does not apply in any prosecution unless the accused, at least ten days before the day fixed for the trial, has given to the prosecutor notice in writing that the accused intends to avail himself of the provisions of subsection (1) and has disclosed to the prosecutor the name and address of the person from whom the accused purchased the article and the date of purchase.

Marginal note:Certificate of analyst

• 35 (1) Subject to this section, in any prosecution for an offence under any of sections 31 to 31.2 and 31.4, a certificate purporting to be signed by an analyst and stating that an article, sample or substance has been submitted to, and analysed or examined by, the analyst and stating the results of the analysis or examination is admissible in evidence and, in the absence of evidence to the contrary, is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed it.

• Marginal note:Requiring attendance of analyst

  (2) The party against whom a certificate of an analyst is produced pursuant to subsection (1) may, with leave of the court, require the attendance of the analyst for the purposes of cross-examination.

• Marginal note:Notice of intention to produce certificate

  (3) No certificate shall be admitted in evidence pursuant to subsection (1) unless, before the trial, the party intending to produce the certificate has given reasonable notice of that intention, together with a copy of the certificate, to the party against whom it is intended to be produced.

• Marginal note:Proof of service

  (4) For the purposes of this Act, service of any certificate referred to in subsection (1) may be proved by oral evidence given under oath by, or by the affidavit or solemn declaration of, the person claiming to have served it.

• Marginal note:Attendance for examination

  (5) Notwithstanding subsection (4), the court may require the person who appears to have signed an affidavit or solemn declaration referred to in that subsection to appear before it for examination or cross-examination in respect of the issue of proof of service.

Marginal note:Proof as to manufacturer or packager

• 36 (1) In a prosecution for a contravention of this Act or of the regulations made under this Part, proof that a package containing any article to which this Act or the regulations apply bore a name or address purporting to be the name or address of the person by whom it was manufactured or packaged is, in the absence of evidence to the contrary, proof that the article was manufactured or packaged, as the case may be, by the person whose name or address appeared on the package.

• Marginal note:Offence by employee or agent

  (2) In a prosecution for a contravention described in subsection (1), it is sufficient proof of the offence to establish that it was committed by an employee or agent of the accused whether or not the employee or agent is identified or has been prosecuted for the offence.

• Marginal note:Certified copies and extracts

  (3) In a prosecution for a contravention described in subsection (1), a copy of a record or an extract therefrom certified to be a true copy by the inspector who made it pursuant to paragraph 23(1)(c) is admissible in evidence and is, in the absence of evidence to the contrary, proof of its contents.

• Marginal note:Where accused had adulterating substances

  (4) Where a person is prosecuted under this Part for having manufactured an adulterated food or drug for sale, and it is established that the person had in his possession or on his premises any substance the addition of which to that food or drug has been declared by regulation to cause the adulteration of the food or drug, the onus of proving that the food or drug was not adulterated by the addition of that substance lies on the accused.

Exports

Marginal note:Conditions under which exports exempt

• 37 (1) This Act does not apply to any packaged food, drug, cosmetic or device if

  • (a) it is manufactured or prepared in Canada;

  • (b) it is intended for export and is not manufactured or prepared for consumption or use in Canada nor sold for consumption or use in Canada;

  • (c) a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner; and

  • (d) the packaged food, drug, cosmetic or device meets any other prescribed requirement.

• Marginal note:Exception — Act

  (1.1) Despite subsection (1),

  • (a) section 4, subsection 5(1) and section 7 apply to any food;

  • (b) section 8, subsection 9(1) and section 11 apply to any drug that is not a natural health product within the meaning of the Natural Health Products Regulations;

  • (c) sections 16 and 18 apply to any cosmetic; and

  • (d) section 19 and subsection 20(1) apply to any device.

• Marginal note:Exception — regulations

  (1.2) Despite subsection (1), any prescribed provision of the regulations respecting the method of manufacture, preparation, preserving, packaging, storing and testing of any food, drug, cosmetic or device applies to any packaged food, drug, cosmetic or device.

• Marginal note:Exception — General Council Decision

  (2) Despite subsection (1), this Act applies in respect of any drug or device to be manufactured for the purpose of being exported in accordance with the General Council Decision, as defined in subsection 30(6), and the requirements of the Act and the regulations apply to the drug or device as though it were a drug or device to be manufactured and sold for consumption or use in Canada, unless the regulations provide otherwise.

PARTS III AND IV[Repealed, 1996, c. 19, s. 81]