Food and Drugs Act · GlobalLawDB

Contents

Short Title

1Short title#

This Act may be cited as the Food and Drugs Act.^note

Interpretation and Application

2Definitions#

In this Act,

advanced therapeutic product means a therapeutic product that is described in Schedule G or that belongs to a class of therapeutic products that is described in that Schedule; (produit thérapeutique innovant)

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 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)

clinical trial means a study, involving human subjects, for the purpose of discovering or verifying the effects of a drug, a device or a food for a special dietary purpose; (essai clinique)

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 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 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 means the Department of Health; (ministère)

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 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 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)

food for a special dietary purpose means a food that has been specially processed or formulated

(a)to meet the particular requirements of an individual in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state, or

(b)to be the sole or primary source of nutrition for an individual; (aliment à des fins diététiques spéciales)

foreign regulatory authority means a government agency or other entity outside Canada that controls the manufacture, use or sale of therapeutic products or foods within its jurisdiction; (autorité réglementaire étrangère)

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

Minister means the Minister of Health; (ministre)

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

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

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

sell includes

(a)offer for sale, expose for sale or have in possession for sale — or distribute to one or more persons, whether or not the distribution is made for consideration, and

(b)lease, offer for lease, expose for lease or have in possession for lease; (vente)

therapeutic product means a drug or device or any combination of drugs and devices; (produit thérapeutique)

therapeutic product authorization means

(a)an authorization, including a licence, that

(i)authorizes the conduct of a clinical trial in respect of a therapeutic product and is issued under the regulations, or

(ii)authorizes, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product and is issued under subsection 21.92(1) or the regulations, or

(b)an authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended; (autorisation relative à un produit thérapeutique)

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)

^note

2.1Non-corrective contact lenses#

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

2.2Tobacco products#

This Act does not apply to a tobacco product as defined in section 2 of the Tobacco and Vaping Products Act.^note

2.3Vaping products#

(1)Despite the definition drug in section 2, this Act does not apply to a vaping product as defined in section 2 of the Tobacco and Vaping Products Act by reason that it contains nicotine, unless the vaping product is manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings.

(2)Despite the definition device in section 2, this Act does not apply to a vaping product as defined in section 2 of the Tobacco and Vaping Products Act by reason that it is manufactured, sold or represented for use with a substance or mixture of substances that contains nicotine, unless the vaping product is manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings.

^note

2.4Classification — thing#

(1)If the Minister believes that a thing falls within two or more of the definitions food, drug, cosmetic and device in section 2, the Minister may, by order, add a description of the thing to a single part of Schedule A that corresponds to one of the definitions in which the thing is believed to fall.

(2)If the Minister believes that every thing in a class of things falls within the same two or more definitions food, drug, cosmetic and device in section 2, the Minister may, by order, add a description of the class to a single part of Schedule A that corresponds to one of the definitions in which the things in the class are believed to fall.

(3)Before adding a description of a thing or a class of things to a part of Schedule A, the Minister shall consider the following factors:

(a)the risk of injury that the thing or things present to human health;

(b)the protection and promotion of health;

(c)the possibility of a person being deceived or misled;

(d)the purposes for which the thing or things are sold, represented or used and the history of use of the thing or things;

(e)the treatment of similar things that have been regulated as foods, drugs, cosmetics or devices under this Act; and

(f)the prescribed factors, if any.

(4)A thing that either is described in or belongs to a class of things that is described in

(a)Part 1 of Schedule A falls within the definition food in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2);

(b)Part 2 of Schedule A falls within the definition drug in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2);

(c)Part 3 of Schedule A falls within the definition cosmetic in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2); and

(d)Part 4 of Schedule A falls within the definition device in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2).

(5)The Minister may, by order, delete the description of a thing or a class of things from Schedule A.

(6)For greater certainty, the definitions food, drug, cosmetic and device in section 2 are subject to subsection (4).

^note

Part I · Foods, Drugs, Cosmetics and Devices

General

3Prohibited advertising#

(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.1.

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

(a)it is represented by label as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1; or

(b)the person advertises it 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.1.

(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.

^note

3.1Prohibition — clinical trials#

No person shall conduct a clinical trial in respect of a drug, device or prescribed food for a special dietary purpose unless the person holds an authorization issued under the regulations that authorizes the conduct of the clinical trial.^note

3.2Terms and conditions — clinical trial authorizations#

The holder of an authorization referred to in section 3.1 shall comply with any terms and conditions of the authorization that are imposed by the Minister under regulations made under paragraph 30(1)(b.3).^note

3.3Duty to publicize clinical trial information#

The holder of an authorization referred to in section 3.1 shall ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner.^note

Food

4Prohibited sales of food#

(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.

(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.

^note

5Deception, etc., regarding food#

(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.

(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).

^note

6Importation and interprovincial movement of food#

(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.

(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).

(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.

^note

6.1Governor in Council may identify standard or portion thereof#

(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.

(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.

^note

7Unsanitary manufacture, etc., of food#

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

Drugs

8Prohibited sales of drugs#

No person shall sell any drug that

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

(b)is adulterated.

^note

9Deception, etc., regarding drugs#

(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.

(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).

^note

10Where standard prescribed for drug#

(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.

(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.

(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.

^note

11Unsanitary manufacture, etc., of drug#

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

12Drugs not to be sold unless safe manufacture indicated#

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.^note

13Drugs not to be sold unless safe batch indicated#

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.^note

14Samples#

No person shall distribute or cause to be distributed any drug as a sample except in accordance with the regulations.^note

15Schedule F drugs not to be sold#

No person shall sell any drug described in Schedule F.^note

Cosmetics

16Prohibited sales of cosmetics#

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.

^note

16.1Prohibited sales — animal testing#

(1)No person shall sell a cosmetic unless the person can establish the safety of the cosmetic without relying on data derived from a test conducted on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal.

(2)The prohibition in subsection (1) does not apply if

(a)the Government of Canada has published the data in a scientific journal or on a Government of Canada website;

(b)the data is publicly available and is derived from a test that was not sponsored by or conducted by or on behalf of a person who manufactures, imports or sells the cosmetic;

(c)the following conditions are met:

(i)the data is derived from a test that was conducted on a substance in order to meet

(A)a requirement under a provision of an Act of Parliament or any of its regulations that applied at the time that the test was conducted, except a requirement that relates only to cosmetics under a provision of this Act or the regulations, or

(B)a requirement that does not relate to cosmetics under the law that applied in a foreign state at the time that the test was conducted,

(ii)the substance is or has been used in a product that is not a cosmetic and that is or has been legally sold in the country where the requirement in question applied, and

(iii)the test was necessary to meet the requirement in order to sell the product in that country;

(d)the data is derived from a test that was conducted before the day on which this section comes into force;

(e)the cosmetic was sold in Canada at any time before the day on which this section comes into force; or

(f)any prescribed circumstance applies.

^note

16.2Prohibition — animal testing#

No person shall conduct a test on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal if the purpose of the test is to meet, with respect to a cosmetic, a requirement under a provision of this Act or the regulations or to meet a requirement that relates to the safety of cosmetics under the law that applies in a foreign state.^note

16.3Prohibited claims — animal testing#

(1)No person shall make a claim on the label of or in an advertisement for a cosmetic that is likely to create an impression that the cosmetic was not tested on animals after the day on which this section comes into force unless the person has evidence that no such testing occurred after that day.

(2)A person who makes a claim described in subsection (1) shall, on the request of the Minister, provide the Minister with the evidence referred to in that subsection.

^note

17Where standard prescribed for cosmetic#

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.^note

18Unsanitary conditions#

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

Devices

19Prohibited sales of devices#

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.^note

20Deception, etc., regarding devices#

(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.

(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).

^note

21Where standard prescribed for device#

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.^note

Therapeutic Products

21.1Power to require information — serious risk#

(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.

(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.

(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.

(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.

^note

21.2Modification or replacement — labelling or packaging#

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.^note

21.3Minister’s powers — risk of injury to health#

(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.

(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.

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

(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.

(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.

(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.

^note

21.301Information — serious environmental risk#

(1)If the Minister believes that a therapeutic product may present a serious risk to the environment, 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.

(a)a government;

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

(c)a person who carries out functions relating to the protection of the environment, including the assessment and management of risks to the environment.

(4)In this section, government has the same meaning as in subsection 21.1(4).

^note

21.302Labelling or packaging — serious risk to environment#

The Minister may, if he or she believes that doing so is necessary to prevent a serious risk to the environment, 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.^note

21.303Minister’s powers — serious risk to environment#

(1)If the Minister believes that a therapeutic product presents a serious or imminent risk to the environment, 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.

(2)Subsections 21.3(2) to (6) apply, with any modifications that the circumstances require, in respect of any order made under subsection (1).

^note

21.31Power to require assessment#

Subject to the regulations, the Minister may order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates and provide the Minister with the results of the assessment.^note

21.32Power to require tests, studies, etc.#

Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on health or safety, order the holder of a therapeutic product authorization to

(a)compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; and

(b)provide the Minister with the information or the results of the tests, studies or monitoring.

^note

21.321Definition of therapeutic product#

Despite the definition therapeutic product in section 2, in sections 21.31 and 21.32 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.^note

21.33Power — information relating to environmental effects#

Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on the environment, order the holder of a therapeutic product authorization to

(a)compile information or conduct tests, studies or monitoring in respect of the therapeutic product; and

(b)provide the Minister with the information or the results of the tests, studies or monitoring.

^note

21.4Statutory Instruments Act#

(1)For greater certainty, orders made under any of sections 21.1 to 21.33 are not statutory instruments within the meaning of the Statutory Instruments Act.

(2)The Minister shall ensure that any order made under any of sections 21.1 to 21.33 is publicly available.

^note

21.5Injunction#

(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.

(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.

^note

21.6False or misleading information — therapeutic products#

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.^note

21.7Terms and conditions of authorizations#

The holder of a therapeutic product authorization shall comply with any terms and conditions of the authorization that are imposed by the Minister under subsection 21.92(3) or under regulations made under paragraph 30(1.2)(b).^note

21.71Duty to publicize clinical trial information#

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

21.8Health care institutions to provide information#

(1)A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.

(2)Despite the definition therapeutic product in section 2, in subsection (1) 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.

^note

Advanced Therapeutic Products

21.9Prohibited activities#

(1)No person shall import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product unless the person

(a)holds a licence in respect of that product that was issued under subsection 21.92(1) and that authorizes the activity in question;

(b)is authorized under an order made under subsection 21.95(1) to conduct the activity in question in respect of the product; or

(c)conducts the activity in question in accordance with the regulations.

(2)For greater certainty, the prohibition applies in respect of an activity regardless of whether the activity is conducted for the purpose of the sale or use of the advanced therapeutic product.

^note

21.91Additions to Schedule G#

(1)For the purpose of preventing injury to health or preventing a person from being deceived or misled, the Minister may, by order, add a description of a therapeutic product or a class of therapeutic products to Schedule G if the Minister believes that the therapeutic product or products represent an emerging or innovative technological, scientific or medical development.

(2)Before adding a description of a therapeutic product or a class of therapeutic products to Schedule G, the Minister shall consider the following factors:

(a)the degree of uncertainty respecting the risks and benefits associated with the therapeutic product or products and the measures that are available to adequately manage and control those risks;

(b)the extent to which the therapeutic product or products are different from therapeutic products for which therapeutic product authorizations have been issued under the regulations;

(c)the extent to which existing legal frameworks are adequate to prevent injury to health or to prevent persons from being deceived or misled; and

(d)the prescribed factors, if any.

(3)The Minister may, by order, delete the description of a therapeutic product or a class of therapeutic products from Schedule G.

^note

21.92Advanced therapeutic product licence#

(1)Subject to the regulations, the Minister may, on application, issue or amend an advanced therapeutic product licence that authorizes a person to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product if the Minister believes that the applicant has provided sufficient evidence to support the conclusion that

(a)the benefits associated with the product outweigh the risks; and

(b)the risks associated with the product and the activity will be adequately managed and controlled.

(2)An application for an advanced therapeutic product licence, or for its amendment, shall be filed with the Minister in the form and manner specified by the Minister and shall set out the information required by the Minister as well as any prescribed information.

(3)The Minister may impose terms and conditions on an advanced therapeutic product licence, including an existing licence, or amend them.

^note

21.93Suspension and revocation#

(1)Subject to the regulations, the Minister may suspend or revoke an advanced therapeutic product licence, in whole or in part, if

(a)the Minister believes that the risks that are associated with the advanced therapeutic product outweigh the benefits;

(b)the Minister believes that the risks associated with the product or any authorized activity are not being adequately managed or controlled;

(c)in the case of a suspension, any prescribed circumstance exists; or

(d)in the case of a revocation, any prescribed circumstance exists.

(2)If the Minister believes that an immediate suspension is necessary to prevent injury to health, the Minister may suspend an advanced therapeutic product licence, in whole or in part, without prior notice to its holder and regardless of whether any of the circumstances referred to in subsection (1) exists.

^note

21.94Exemption#

The holder of an advanced therapeutic product licence is, in respect of the activities authorized under the licence, exempt from the provisions of the regulations other than any provisions that are specified in regulations made under paragraph 30(1.2)(b.2).^note

21.95Order — advanced therapeutic products#

(1)The Minister may make an order, with or without terms and conditions, that authorizes any person within a class of persons that is specified in the order to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product.

(2)The Minister may, in the order,

(a)specify provisions of the regulations that are excluded from the scope of the exemption provided for in section 21.96; and

(b)establish classes and distinguish among those classes.

(3)A person that conducts an activity under the order shall comply with any applicable terms and conditions.

^note

21.96Exemption#

A person that conducts an activity under an order made under subsection 21.95(1) is, in respect of the activity, exempt from the provisions of the regulations other than any provisions that are specified in the order or in regulations made under paragraph 30(1.2)(b.2).^note

Part II · Administration and Enforcement

Inspection, Seizure and Forfeiture

22Inspectors#

(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.

(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.

^note

22.1Provision of documents, information or samples#

(1)An inspector may, for a purpose related to verifying compliance or preventing non-compliance with the provisions of this Act or the regulations, order a person to provide, on or before the date and time specified by the inspector and at the place and in the manner specified by the inspector, any document, information or sample specified by the inspector.

(2)A person that is ordered by an inspector to provide a document, information or a sample shall do so on or before the date and time, and at the place and in the manner, specified by the inspector.

^note

23Powers of inspectors#

(1)Subject to subsection (9), an inspector may, for a purpose related to verifying compliance or preventing non-compliance with the provisions of this Act or the regulations, enter any place, including a conveyance, in which they believe on reasonable grounds

(a)an activity that may be regulated under this Act is being conducted;

(b)any article to which this Act or the regulations apply is located;

(c)an activity could be conducted under an authorization, including a licence, for which an application is under consideration by the Minister; or

(d)an activity could be conducted as a result of an exemption that is under consideration by the Minister.

(2)The inspector may, in the place entered under subsection (1),

(a)examine any article to which this Act or the regulations apply or anything that the inspector believes on reasonable grounds is used or is capable of being used for an activity regulated under this Act;

(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 take extracts from — any record, report, electronic data or other document that is found at the place and that the inspector believes on reasonable grounds includes information relevant to the administration of this Act or the regulations;

(d)cause to be reproduced any electronic data referred to in paragraph (c);

(e)use, or cause to be used, any computer system or telecommunication system at the place;

(f)examine — and reproduce or cause to be reproduced — any electronic data that is contained in or available to a system referred to in paragraph (e) and that the inspector believes on reasonable grounds includes information relevant to the administration of this Act or the regulations;

(g)remove, for examination or copying, any copies made or extracts taken under paragraph (c), (d) or (f);

(h)test anything that the inspector believes on reasonable grounds is an article to which this Act or the regulations apply;

(i)take samples of any food, drug, cosmetic, device or anything used for an activity regulated under this Act;

(j)take photographs and make recordings and sketches;

(k)remove anything from the place for the purpose of examination, conducting tests or taking samples; and

(l)seize and detain for the time that may be necessary any article that the inspector believes on reasonable grounds is an article by means of, or in relation to which, any provision of this Act or the regulations has been contravened.

(3)For the purposes of subsection (1), an inspector is considered to have entered a place when they access it remotely by a means of telecommunication.

(4)An inspector who enters remotely, by a means of telecommunication, a place that is not accessible to the public shall do so with the knowledge of the owner or person in charge of the place and only for the period necessary for the purpose referred to in subsection (1).

(5)For the purpose of entering a conveyance, an inspector may order the owner or person having possession, care or control of the conveyance to stop it or move it.

(6)An owner or person who, under subsection (5), is ordered to stop or move a conveyance shall stop or move it.

(7)An inspector may be accompanied by any other individual that the inspector believes is necessary to help them exercise their powers or perform their duties or functions under this section.

(8)An inspector and any individual accompanying them may enter and pass through private property, other than a dwelling-house on that property, in order to gain entry to a place referred to in subsection (1). For greater certainty, they are not liable for doing so.

(9)In the case of a dwelling-house, an inspector may enter it only with the consent of the occupant or under the authority of a warrant issued under subsection (10).

(10)A justice of the peace may, on ex parte application, issue a warrant authorizing the inspector named in it to enter a dwelling-house, subject to any conditions specified in the warrant, if the justice is satisfied by information on oath that

(a)the dwelling-house is a place referred to in subsection (1);

(b)entry to the dwelling-house is necessary for a purpose referred to in that subsection; and

(c)entry to the dwelling-house has been refused or there are reasonable grounds to believe that it will be refused.

(11)In executing a warrant issued under subsection (10), an inspector shall not use force unless they are accompanied by a peace officer and the use of force is specifically authorized in the warrant.

(12)An application for a warrant under subsection (10) may be submitted, and the warrant may be issued, by a means of telecommunication and section 487.1 of the Criminal Code applies for those purposes with any necessary modifications.

(13)The owner or other person in charge of a place entered by an inspector under subsection (1) and every individual found there shall

(a)give the inspector all reasonable assistance; and

(b)provide the inspector with any information that the inspector may reasonably require, including information that is necessary to establish their identity to the inspector’s satisfaction.

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

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

(b)anything used for an activity regulated under this Act; and

(c)any record, report, electronic data or other document — including any labelling or advertising material — relating to the administration of this Act or the regulations.

24Obstruction 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.

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

^note

25Storage, movement and disposal#

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.

^note

26Release 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.^note

26.1Unclaimed seized articles#

(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.

(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.

^note

27Forfeiture with consent#

(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.

(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.

(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.

^note

Removal, Forfeiture or Destruction of Unlawful Imports

27.1Unlawful imports#

(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.

(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.

(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.

(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.

(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.

^note

27.2Removal or destruction#

(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.

(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.

(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.

(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.

(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.

(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.

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

^note

Preventive and Remedial Measures

27.3Measures#

(1)If the Minister has reasonable grounds to believe that a person has contravened, or is likely to contravene, this Act or the regulations, the Minister may order the person to take any measures that the Minister considers necessary to remedy the contravention or prevent it.

(2)A person that is ordered to take measures shall take them.

^note

Analysis

28Analysts#

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

29Analysis 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.

(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.

(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.

^note

Power of the Minister

29.1List#

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

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

^note

29.2 #

[Repealed, 2024, c. 17, s. 324] (repealed)

Regulations

30Regulations#

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

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

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

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

(b)respecting

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(o)respecting

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

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

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

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

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

(r)[Repealed, 2024, c. 17, s. 325] (repealed)

(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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(i)is not confidential business information, or

(ii)has ceased to be confidential business information;

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

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

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

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

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

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

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

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

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

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

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

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

(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.

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

(4)In subsection (3),

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

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

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)

(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.

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

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 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 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 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)

Supplementary Rules

30.01Supplementary rules — therapeutic product#

(1)Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes on reasonable grounds that the use of a therapeutic product, other than the intended use, may present a risk of injury to health, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the therapeutic product for the purpose of preventing, managing or controlling the risk of injury to health.

(2)For greater certainty, the Minister may, in the order, establish rules for the purpose of preventing the therapeutic product from being promoted for a use, other than the intended use, of a therapeutic product or preventing a use, other than the intended use, of a therapeutic product from being appealing.

(3)The Minister may make the order despite any uncertainty respecting the risk of injury to health that the use of the therapeutic product, other than the intended use, may present.

^note

30.02Supplementary rules — drug intended for animal#

(1)Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes on reasonable grounds that the use of a drug intended for an animal of a particular species, including a use other than the intended use, may present a risk of adverse effects to human beings, animals of a different species or the environment, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the drug for the purpose of preventing, managing or controlling the risk of adverse effects.

(2)The Minister may make the order despite any uncertainty respecting the risk of adverse effects that the use of the drug, including a use other than the intended use, may present.

^note

30.03Statutory Instruments Act#

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

30.04Availability — person-specific orders#

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

Exemption

30.05Exemption — foods and therapeutic products#

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

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

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

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

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

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

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

^note

Decision of Foreign Regulatory Authority

30.06Deeming order#

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

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

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

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

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

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

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

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

(5)For greater certainty,

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

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

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

^note

Reference to Regulations

30.07Deeming#

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

Interim Orders

30.1Interim orders#

(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.

(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.

(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.

(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.

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

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

(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.

^note

30.2 #

[Repealed, 2024, c. 17, s. 330] (repealed)

30.3 #

[Repealed, 2024, c. 17, s. 330] (repealed)

30.4 #

[Repealed, 2024, c. 17, s. 330] (repealed)

Incorporation by Reference

30.5Incorporation by reference#

(1)A regulation made under this Act with respect to a food or therapeutic product and an order made under subsection 30.63(1) 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.

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

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

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

^note

30.6Existing power not limited#

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.^note

Fees

30.61Fees#

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

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

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

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

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

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

^note

30.62Consultation#

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

30.63Remission of fees#

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

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

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

^note

30.64Non-payment of fees#

The Minister may withdraw or withhold a service, the use of a facility, a regulatory process or approval or a product, right or privilege under this Act from any person who fails to pay the fee fixed for it under subsection 30.61(1).^note

30.65Adjustment of amounts#

(1)An order made under subsection 30.61(1) may prescribe rules for the adjustment of the amount of the fee by any amounts or ratios that are referred to in the order, for the period that is specified in the order.

(2)The amount of a fee that is subject to an adjustment rule remains unadjusted for the specified period unless, before the beginning of that period, the Minister publishes a notice in the Canada Gazette that specifies the adjusted amount and the manner in which it was determined.

^note

30.66Service Fees Act#

The Service Fees Act does not apply to a fee fixed under subsection 30.61(1).^note

Costs

30.7Recovery#

(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.

(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.

^note

30.8Certificate of default#

(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.

(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.

^note

Offences and Punishment

31Contravention of Act or regulations#

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.

^note

31.1Offences relating to food#

(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.

(2)For greater certainty, subsection (1) applies in respect of the following provisions of this Act:

(a)section 3, if the contravention of that section involves food;

(a.1)section 3.1 or 3.3, if the contravention of that section involves a clinical trial that relates to food;

(a.2)section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to food;

(b)subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to food or a sample that is or relates to food;

(c)subsection 23(6), if the contravention of that subsection involves a conveyance in respect of which an inspector is exercising powers or performing duties or functions in relation to food;

(d)subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to food;

(e)subsection 24(1), if the contravention of that subsection involves the obstruction or hindering of — or the making of a false or misleading statement to — an inspector who is carrying out duties or functions in relation to food;

(f)subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to food; and

(g)subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to food.

^note

31.2Offences relating to therapeutic products#

(1)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 21.32 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.

(2)For greater certainty, subsection (1) applies in respect of the following provisions of this Act:

(a)section 3, if the contravention of that section involves a therapeutic product;

(a.1)section 3.1 or 3.3, if the contravention of that section involves a clinical trial that relates to a therapeutic product;

(a.2)section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to a therapeutic product;

(b)subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to a therapeutic product or a sample that is or relates to a therapeutic product;

(c)subsection 23(6), if the contravention of that subsection involves a conveyance in respect of which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;

(d)subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;

(f)subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to a therapeutic product; and

(g)subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to a therapeutic product.

^note

31.3Due diligence#

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

31.4Offences — section 21.6 and serious risk#

(1)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 21.32 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.

(2)For greater certainty, subsection (1) applies in respect of the following provisions of this Act:

(a)section 3, if the contravention of that section involves a therapeutic product;

(a.1)section 3.1, if the contravention of that section involves a clinical trial that relates to a therapeutic product;

(a.2)section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to a therapeutic product;

(b)subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to a therapeutic product or a sample that is or relates to a therapeutic product;

(d)subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;

(f)subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to a therapeutic product; and

(g)subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to a therapeutic product.

^note

31.5Sentencing considerations#

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.

^note

31.6Parties to offence#

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.^note

31.7Continuing offence#

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.^note

32Limitation period#

(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.

(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.

^note

33Venue#

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.^note

34Want of knowledge#

(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.

(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.

^note

35Certificate of analyst#

(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.

(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.

(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.

(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.

(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.

^note

36Proof as to manufacturer or packager#

(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.

(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.

(3)In a prosecution for a contravention described in subsection (1), a copy of or extract from a document, including electronic data, that is certified to be a true copy by the inspector who made or took it under paragraph 23(2)(c), (d) or (f), as the case may be, is admissible in evidence and is, in the absence of evidence to the contrary, proof of its contents.

(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.

^note

Exports

37Conditions under which exports exempt#

(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.

(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.

(1.2)Despite subsection (1), any prescribed provision of the regulations applies to any food, drug, cosmetic or device.

(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.

^note

38Conditions under which transhipment exempt#

This Act does not apply to any packaged food, drug, cosmetic or device if

(a)it is manufactured or prepared outside Canada;

(b)it is imported solely for the purpose of export and is not sold for consumption or use in Canada; and

(c)it meets any other prescribed requirement.

^note

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

Schedule A · (Section 2.4)

Schedule A.1 · (Section 3)

Schedule B · (Section 10)

Schedule C · (Section 12)

Schedule D · (Section 12)

Schedule E · (Section 13)

[There are no items in this Schedule.]

Schedule F · (Section 15)

[There are no items in this Schedule of the FOOD AND DRUGS ACT.]

Schedule G · (Sections 2 and 21.91)

Item | Description | |

Schedule H

[Repealed, 1996, c. 19, s. 82]

Related provisions

— R.S., 1985, c. 27 (1st Supp.), s. 208Nothing in sections 190, 195, 199 and 200 of this Act shall be construed as rendering invalid or inadmissible in any proceedings any evidence obtained by the exercise of a writ of assistance prior to the coming into force of those sections. — 1997, c. 6, s. 66(2)For greater certainty, the two year limitation period provided for in subsection 32(1) of the Act, as amended by subsection (1), only applies in respect of offences committed after the coming into force of that subsection. — 2005, c. 42, s. 4A Notice of Interim Marketing Authorization that is issued under the Food and Drug Regulations before the day on which this section comes into force, in respect of any matter referred to in subsection 30.2(2) of the Food and Drugs Act, as enacted by section 3 of this Act, and that is in effect on the day on which this section comes into force, is deemed to be an interim marketing authorization issued under subsection 30.2(1) of that Act. — 2005, c. 42, s. 5(1)The maximum residue limit established for an agricultural chemical and its derivatives under the Food and Drug Regulations, as those regulations read immediately before the coming into force of this subsection, is deemed, if the agricultural chemical is a pest control product as defined in subsection 2(1) of the Pest Control Products Act, chapter 28 of the Statutes of Canada, 2002, to have been specified by the Minister under section 9 or 10 of that Act as the maximum residue limit for that agricultural chemical and its derivatives. — 2012, c. 19, s. 417An interim marketing authorization that is issued under subsection 30.2(1) of the Food and Drugs Act and in effect immediately before the day on which section 416 comes into force continues to have effect until the earliest ofthe day on which the Minister of Health publishes a notice cancelling the interim marketing authorization in the Canada Gazette;the day on which a marketing authorization — or any part of it — that is issued under subsection 30.3(1) of the Food and Drugs Act, as enacted by section 416, has the same effect as the interim marketing authorization; andtwo years after the day on which the interim marketing authorization is published in the Canada Gazette.A notice cancelling an interim marketing authorization is exempt from sections 3, 5 and 11 of the Statutory Instruments Act. — 2014, c. 24, s. 13The definition therapeutic product authorization, as enacted by subsection 2(3), applies to authorizations — including licences and suspended authorizations or licences — that were issued before the day on which this section comes into force and that authorize, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product. — 2019, c. 29, s. 180A person that, immediately before the coming into force of section 166, is authorized under Division 5 of Part C of the Food and Drug Regulations to sell or import a drug for the purposes of a clinical trial is deemed to be the holder, in respect of that drug, of an authorization referred to in section 3.1 of the Food and Drugs Act, as enacted by that section 166. — 2019, c. 29, s. 181A person that, immediately before the coming into force of section 166, is authorized under Division 3 of Part C of the Food and Drug Regulations to sell or import a positron-emitting radiopharmaceutical for the purposes of a study is deemed to be the holder, in respect of that positron-emitting radiopharmaceutical, of an authorization referred to in section 3.1 of the Food and Drugs Act, as enacted by that section 166. — 2019, c. 29, s. 182A person that, immediately before the coming into force of section 166, is authorized under Part 4 of the Natural Health Products Regulations to sell or import a natural health product for the purposes of a clinical trial is deemed to be the holder, in respect of that natural health product, of an authorization referred to in section 3.1 of the Food and Drugs Act, as enacted by that section 166. — 2019, c. 29, s. 183A person that, immediately before the coming into force of section 166, is authorized under Part 3 of the Medical Devices Regulations to sell or import a Class II, III or IV medical device for investigational testing is deemed to be the holder, in respect of the device, of an authorization referred to in section 3.1 of the Food and Drugs Act, as enacted by that section 166. — 2022, c. 17, s. 76For greater certainty, but subject to sections 77 and 78, the amendments made by this Act also apply with respect to proceedings that are ongoing on the day on which this Act comes into force. — 2022, c. 17, par. 77(2)(a)Each of the following provisions, as it read immediately before the day on which this Act comes into force, continues to apply with respect to an application made for a warrant under the provision if the application is submitted, and no decision has been made in respect of the application, before that day:subsection 23(12) of the Food and Drugs Act; — 2022, c. 17, s. 78.1The Minister of Justice must, no later than three years after the day on which this Act receives royal assent, initiate one or more independent reviews on the use of remote proceedings in criminal justice matters that must include an assessment of whether remote proceedingsenhance, preserve or adversely affect access to justice;maintain fundamental principles of the administration of justice; andadequately address the rights and obligations of participants in the criminal justice system, including accused persons.The Minister of Justice must, no later than five years after the day on which a review is initiated, cause a report on the review — including any findings or recommendations resulting from it — to be laid before each House of Parliament. — 2022, c. 17, s. 78.2At the start of the fifth year after the day on which this Act receives royal assent, the provisions enacted or amended by this Act are to be referred to a committee of the Senate and a committee of the House of Commons that may be designated or established for the purpose of reviewing the provisions.The committees to which the provisions are referred are to review them and the use of remote proceedings in criminal justice matters and submit reports to the Houses of Parliament of which they are committees, including statements setting out any changes to the provisions that they recommend. — 2023, c. 26, s. 503The definition therapeutic product authorization in section 2 of the Food and Drugs Act also includesan authorization, including a licence, that was issued, before the day on which this section comes into force, under the regulations made under that Act and that authorizes, as the case may be, the import, sale, manufacture, packaging or labelling of a natural health product, within the meaning of the Natural Health Products Regulations as those Regulations read immediately before that day; oran authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended. — 2024, c. 17, s. 332Marketing authorizations issued under section 30.2 or 30.3 of the Food and Drugs Act, as those sections read immediately before the day on which section 330 comes into force, that have not been repealed before that day are deemed to be made under subsection 30.05(1) of that Act.

Amendments not in force

— 2023, c. 12, s. 64The Food and Drugs Act is amended by adding the following after section 11:It is prohibited for a person to sell, or to manufacture, prepare, preserve, package or store for sale, any drug that contains a prescribed substance, unless the Minister has conducted an assessment, in accordance with the regulations made under paragraph 30(1)(l.1), of the risk to the environment presented by the substance. — 2023, c. 12, s. 67[In force]Subsection 30(1) of the Act is amended by adding the following after paragraph (a.01):prescribing the substances that are subject to an assessment under section 11.1;[In force]Paragraph 30(1)(l.1) of the Act is replaced by the following:respecting the assessment of the risk to the environment or human life and health of the release into the environment of any food, drug, cosmetic or device;respecting, for the purpose of managing risks to the environment identified as part of an assessment under this Act, measures in respect of selling or importing, manufacturing, preparing, preserving, packaging or storing for sale any food, drug, cosmetic or device;authorizing the Minister to waive any requirement respecting the assessment under this Act of the risk to the environment presented by a food, drug, cosmetic or device;Section 30 of the Act is amended by adding the following after subsection (1):Before recommending to the Governor in Council that a regulation be made under paragraph (1)(a.02), the Minister must take into account the degree of uncertainty respecting the risks to the environment associated with the use of a substance as an ingredient in a drug, including its release into the environment.[In force] — 2023, c. 26, s. 501(2)Section 21.321 of the Act is repealed. — 2023, c. 26, s. 502(2)Subsection 21.8(2) of the Act is repealed. — 2024, c. 17, s. 327Section 30.05 of the Act is amended by adding the following after subsection (1):Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, on any conditions that the Minister considers necessary, exempt a person — or any food, therapeutic product or activity, or any class of foods, therapeutic products or activities, in relation to a person — from the application of all or any of the provisions of Part I, section 37 or the regulations. The order cannot relate to cosmetics.The portion of subsection 30.05(2) of the Act before paragraph (a) is replaced by the following:The Minister may make an order under subsection (1) or (1.1) only if the Minister believes on reasonable grounds thatSection 30.05 of the Act is amended by adding the following after subsection (3):An order made under subsection (1.1) that applies to only one person is not a statutory instrument within the meaning of the Statutory Instruments Act.The Minister must ensure that any order made under subsection (1.1) is publicly available but may exclude personal information and confidential business information from the order.

Federal laws of Canada reproduced under the Reproduction of Federal Law Order (SI/97-5); not the official version. Source: Justice Laws Website.