Bill C-51
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2nd Session, 39th Parliament,
56-57 Elizabeth II, 2007-2008
house of commons of canada
BILL C-51
An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts
Preamble
Whereas the Parliament of Canada recognizes the objectives of protecting, promoting and improving human health;
Whereas the Parliament of Canada recognizes that those objectives can only be realized through a continued commitment to the health and safety of the public;
Whereas the Parliament of Canada recognizes that ongoing assessment of information about a therapeutic product over its life cycle is required both before and after it reaches the market in order to support its safe use;
Whereas the Parliament of Canada recognizes that cooperation among regulators of foods, therapeutic products and cosmetics contributes to the health and safety of the public;
Whereas the Parliament of Canada recognizes that the assessment of benefits and risks is to be based on scientific and objective evidence;
Whereas the Parliament of Canada recognizes that a lack of full scientific certainty is not to be used as a reason for postponing measures that prevent adverse effects on human health if those effects could be serious or irreversible;
Whereas the Parliament of Canada recognizes the objective of promoting accurate and consistent product representation;
Whereas the Parliament of Canada recognizes that it is the responsibility of regulated persons to ensure that only products that meet legislative requirements are available to the public;
And whereas the Parliament of Canada recognizes that openness and transparency, including the sharing of information and the meaningful involvement of the public in seeking the input of those impacted by regulatory decisions, help advance understanding of risks and benefits and enhance the credibility of and public trust in decision-making;
Now, therefore, Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
R.S., c. F-27
FOOD AND DRUGS ACT
1. The long title of the Food and Drugs Act is replaced by the following:
An Act respecting foods, therapeutic products and cosmetics
2. The heading before section 2 of the French version of the Act is replaced by the following:
DÉFINITIONS ET INTERPRÉTATION
3. (1) The definition “contraceptive device” in section 2 of the Act is repealed.
(2) The definition ““publicité” ou “annonce”” in section 2 of the French version of the Act is repealed.
R.S., c. 27 (1st Supp.), s. 191; 1993, c. 34, ss. 71(2)(F) and (3); 1996, c. 8, par. 32(1)(g); 1997, c. 6, s. 62
(3) The definitions “analyst”, “device”, “inspector”, “label”, “Minister”, “package”, “sell” and “unsanitary conditions” in section 2 of the Act are replaced by the following:
“analyst”
« analyste »
« analyste »
“analyst” means an individual designated as an analyst under section 28 or under subsection 13(3) of the Canadian Food Inspection Agency Act;
“device”
« instrument »
« instrument »
“device” means an article, instrument, apparatus or contrivance — including a component, part or accessory of one — that is 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 the body structure of human beings or animals or the functioning of parts of the bodies of human beings or animals,
(c) the diagnosis of pregnancy in human beings or animals,
(d) the care of human beings or animals during pregnancy or at or after the birth of the offspring, including care of the offspring, or
(e) the prevention of conception in human beings or animals;
“inspector”
« inspecteur »
« inspecteur »
“inspector” means an individual designated as an inspector under subsection 22(1) or under subsection 13(3) of the Canadian Food Inspection Agency Act;
“label”
« étiquette »
« étiquette »
“label” includes a legend, word or mark that is attached to, is included in or accompanies a food, therapeutic product, cosmetic or package;
“Minister”
« ministre »
« ministre »
“Minister” means the Minister of Health or, for the purposes of the responsibilities set out in subsection 11(3) of the Canadian Food Inspection Agency Act, the Minister of Agriculture and Agri-Food;
“package”
« emballage »
« emballage »
“package” includes anything in which a food, therapeutic product or cosmetic is wholly or partly contained or packed;
“sell”
« vente »
« vente »
“sell” includes 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, in relation to a device, includes lease, offer for lease, expose for lease or have in possession for lease;
“unsanitary conditions”
« conditions non hygiéniques »
« conditions non hygiéniques »
“unsanitary conditions” means conditions or circumstances that could contaminate with dirt or filth, or render injurious to health, a food, therapeutic product or cosmetic.
(4) The definition “advertisement” in section 2 of the English version of the Act is replaced by the following:
“advertisement”
« publicité »
« publicité »
“advertisement” includes a representation by any means for the purpose of promoting directly or indirectly the sale of a food, therapeutic product or cosmetic;
(5) Paragraph (c) of the definition “drug” in section 2 of the Act is replaced by the following:
(c) disinfection of premises in which a food is manufactured, prepared or kept;
(6) Section 2 of the Act is amended by adding the following in alphabetical order:
“article to which this Act or the regulations apply”
« article visé par la présente loi ou les règlements »
« article visé par la présente loi ou les règlements »
“article to which this Act or the regulations apply” includes
(a) a food, therapeutic product or cosmetic, and
(b) anything, including a document, that is used in an activity that is governed by this Act or the regulations;
“clinical trial”
« essai clinique »
« essai clinique »
“clinical trial” means
(a) an investigation in respect of a therapeutic product for use in human beings that involves human subjects and that is intended to discover or verify the therapeutic product’s clinical, pharmacological or pharmacodynamic effects, to identify adverse events in respect of the therapeutic product, to study the absorption, distribution, metabolism or excretion of the therapeutic product or to ascertain its safety or efficacy, or
(b) an investigation in respect of a drug for use in animals that produce food, that are intended for consumption as food or in which the use of the drug could affect human health;
“clinical trial authorization”
« autorisation d’essai clinique »
« autorisation d’essai clinique »
“clinical trial authorization” means an authorization issued under section 18.2;
“confidential business information”
« renseignements commerciaux confidentiels »
« renseignements commerciaux confidentiels »
“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;
“controlled activity”
« activité contrôlée »
« activité contrôlée »
“controlled activity” means
(a) in relation to a therapeutic product —manufacturing, collecting, processing, pre- serving, labelling, packaging, importing for sale, distributing, wholesaling or testing, and
(b) in relation to a designated therapeutic product —manufacturing, collecting, processing, preserving, labelling, packaging, importing, distributing or testing;
“designated therapeutic product”
« produit thérapeutique désigné »
« produit thérapeutique désigné »
“designated therapeutic product” means a therapeutic product designated as such by regulations made under paragraph 30(1)(d);
“document”
« document »
« document »
“document” means anything on which information is recorded or marked and that is capable of being understood by a person or read by a computer or other device;
“establishment licence”
« licence d’établissement »
« licence d’établissement »
“establishment licence” means a licence issued under section 19.2;
“government”
« administration »
« administration »
“government” means any of the following or their institutions, as applicable:
(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;
“market authorization”
« autorisation de mise en marché »
« autorisation de mise en marché »
“market authorization” means an authorization issued under section 18.7;
“person”
« personne »
« personne »
“person” means an individual or an organization as defined in section 2 of the Criminal Code;
“personal information”
« renseignements personnels »
« renseignements personnels »
“personal information” has the same meaning as in section 3 of the Privacy Act;
“practitioner”
« praticien »
« praticien »
“practitioner” means an individual who is authorized under the law of a province to prescribe or dispense prescription therapeutic products;
“prescription therapeutic product”
« produit thérapeutique sur ordonnance »
« produit thérapeutique sur ordonnance »
“prescription therapeutic product” means a therapeutic product designated as such by an order made under subsection 15.1(4);
“therapeutic product”
« produit thérapeutique »
« produit thérapeutique »
“therapeutic product” means
(a) a drug,
(b) a device,
(c) cells, tissues or organs that are distributed or represented for use in
(i) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, or
(ii) restoring, correcting or modifying the body structure of human beings or animals or the functioning of parts of the bodies of human beings or animals, or
(d) a combination of two or more of the things referred to in paragraphs (a) to (c);
(7) Section 2 of the French version of the Act is amended by adding the following in alphabetical order:
« publicité »
“advertisement”
“advertisement”
« publicité » S’entend notamment de toute présentation visant par un moyen quelconque à encourager directement ou indirectement la vente d’un aliment, d’un produit thérapeutique ou d’un cosmétique.
1993, c. 34, s. 72(F)
4. The headings before section 3 and sections 3 and 4 of the Act are replaced by the following:
Product monographs and contact lenses
2.1 For the purposes of this Act,
(a) a product monograph of a therapeutic product is deemed to be a label even if it is not attached to or included in or does not accompany the therapeutic product; and
(b) a contact lens is deemed to be a device.
Clinical trial authorization or market authorization
2.2 For the purposes of this Act, a therapeutic product has a clinical trial authorization or a market authorization if, at the relevant time, a person is the holder of a clinical trial authorization or a market authorization in respect of the therapeutic product.
PURPOSE
Purpose
2.3 The purpose of this Act is to protect and promote the health and safety of the public and encourage accurate and consistent product representation by prohibiting and regulating certain activities in relation to foods, therapeutic products and cosmetics.
PROHIBITIONS
General
False or misleading information
3. No person shall knowingly provide the Minister with false or misleading information in relation to a matter under this Act or the regulations, including in relation to an application for a licence, registration or authorization.
Tampering
3.1 (1) No person shall tamper with a food, therapeutic product or cosmetic — or its label or package — with the intent to
(a) render the food, therapeutic product or cosmetic injurious to human health; or
(b) cause a reasonable apprehension in others that the food, therapeutic product or cosmetic is injurious to human health without themself believing that it is so.
Selling or importing for sale
(2) No person shall sell or import for sale a food, therapeutic product or cosmetic that was tampered with in order to render it injurious to human health.
Threats
(3) No person shall threaten to tamper with a food, therapeutic product or cosmetic in order to render it injurious to human health.
Hoaxes
3.2 No person shall — knowing information to be false or being reckless as to its truth — communicate or cause to be communicated that information with the intent to cause a reasonable apprehension in others that a food, therapeutic product or cosmetic is adulterated, was manufactured, processed, prepared, preserved, packaged, stored or conveyed under unsanitary conditions or was tampered with in order to render it injurious to human health.
Foods
Prohibited sales and imports
4. No person shall sell or import for sale a food that
(a) has a poisonous or harmful substance in or on it;
(b) is unfit for human consumption;
(c) is injurious to human health;
(d) is adulterated; or
(e) was manufactured, processed, prepared, preserved, packaged, stored or conveyed under unsanitary conditions.
5. (1) Subsection 5(1) of the Act is replaced by the following:
Deception, etc.
5. (1) No person shall manufacture, process, label, package, sell, import for sale or advertise a 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, safety or origin.
(2) Subsection 5(2) of the English version of the Act is replaced by the following:
Labelled or packaged contrary to regulations
(2) A food that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations is deemed to be labelled or packaged contrary to subsection (1).
6. The Act is amended by adding the following after section 5:
Importation
5.1 No person shall import a prescribed food for sale unless they are authorized by a registration or licence to do so.
Interprovincial trade — licence or registration required
5.2 No person shall send or convey from one province to another a prescribed food that is intended for sale unless they are authorized by a registration or licence to do so.
Interprovincial trade — persons conducting prescribed activities
5.3 No person shall send or convey from one province to another a prescribed food that is intended for sale unless the persons who conduct prescribed activities relating to the prescribed food are authorized by a registration or licence to do so.
Interprovincial trade — establishments
5.4 No person shall send or convey from one province to another a prescribed food that is intended for sale unless the establishments in which prescribed activities relating to the prescribed food are conducted are registered.
R.S., c. 27 (3rd Supp.), s. 1
7. Subsection 6(2) of the Act is repealed.
8. Sections 7 to 21 and the headings after section 21 of the Act are replaced by the following:
Unsanitary conditions
7. No person shall manufacture, process, prepare, preserve, package, store or convey for sale any food under unsanitary conditions.
Therapeutic Products
Adulterated products
8. No person shall sell or import for sale a therapeutic product that is adulterated.
Unsanitary conditions — manufacture, etc.
9. (1) No person shall manufacture, collect, process, prepare, preserve, package, store or convey for sale a therapeutic product under unsanitary conditions.
Unsanitary conditions —sell, etc.
(2) No person shall sell or import for sale a therapeutic product that was manufactured, collected, processed, prepared, preserved, packaged, stored or conveyed under unsanitary conditions.
No clinical trial without authorization
10. No person shall conduct a clinical trial in respect of a therapeutic product that does not have a market authorization unless they are authorized by a clinical trial authorization to do so.
No clinical trial contrary to regulations
11. No person shall conduct a clinical trial in respect of a therapeutic product unless they do so in accordance with the regulations.
Selling, advertising and importing
12. (1) No person shall advertise, sell or import for sale a therapeutic product that does not have a market authorization or is not a designated therapeutic product.
Exception
(2) A person does not contravene subsection (1) if
(a) they are the holder of a clinical trial authorization and the advertising, selling or importing is for the purpose of a clinical trial to which the authorization relates; or
(b) they sell the therapeutic product to a person who is the holder of a clinical trial authorization or they import it for sale to that person.
Conducting controlled activity
13. No person shall conduct a controlled activity unless they are authorized by an establishment licence to do so.
Deception, etc.
14. No person shall manufacture, process, label, package, sell, import for sale or advertise a therapeutic product in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its benefits, risks, conditions of use, quality, quantity, composition, design, construction, performance, origin or authorization status.
Counterfeiting
15. No person shall manufacture, label, package, sell, import for sale or advertise a therapeutic product that resembles one that has a market authorization or establishment licence and is likely to be mistaken for the one that has a market authorization or establishment licence.
Prescription therapeutic products — unauthorized sale
15.1 (1) No person shall sell a prescription therapeutic product unless
(a) they are a practitioner who is authorized to prescribe the prescription therapeutic product;
(b) the sale is made under a prescription that was received by or transferred to them in the prescribed manner;
(c) the sale is to a person who belongs to a prescribed class of persons; or
(d) the sale is made in the prescribed circumstances.
Unauthorized advertising
(2) No person shall advertise a prescription therapeutic product to a person other than a practitioner unless they are authorized by the regulations to do so.
Importation
(3) No person shall import a prescription therapeutic product unless
(a) they belong to a prescribed class of persons;
(b) they are a practitioner;
(c) they are an individual, the product is on their person at the time that it is imported, the product is for their use or the use of an accompanying dependant and the quantity does not exceed the quantity required for a 90-day period; or
(d) the importation is made in the prescribed circumstances.
Designation
(4) Subject to the regulations, the Minister may, by order, designate a therapeutic product— either individually or by class — as a prescription therapeutic product for the purposes of this section.
Samples — drugs
15.2 (1) No person shall distribute or cause to be distributed a drug as a sample.
Exception
(2) Subsection (1) does not apply to the distribution under prescribed conditions of a sample of a drug by or to a practitioner.
Prohibited sales and imports
16. No person shall sell or import for sale a cosmetic that
(a) presents a significant risk of injury to health if it is used according to directions or under customary or usual conditions;
(b) is adulterated; or
(c) was manufactured, processed, prepared, preserved, packaged, stored or conveyed under unsanitary conditions.
Deception, etc.
16.1 No person shall manufacture, process, label, package, sell, import for sale or advertise a cosmetic 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.
If standard prescribed
17. If a standard has been prescribed for a cosmetic, no person shall label, package, sell, import for sale or advertise anything in a manner such that it is likely to be mistaken for the cosmetic unless it complies with the prescribed standard.
Unsanitary conditions
18. No person shall manufacture, process, prepare, preserve, package, store or convey for sale a cosmetic under unsanitary conditions.
AUTHORIZATIONS AND LICENCES
Foods
Ministerial authorization
18.1 (1) Subject to the regulations, the Minister may, on application
(a) register a person, or issue a licence to a person, authorizing them to import a prescribed food for sale;
(b) register a person, or issue a licence to a person, authorizing them to send or convey from one province to another a prescribed food that is intended for sale;
(c) register a person, or issue a licence to a person, authorizing them to conduct a prescribed activity in relation to a prescribed food that is intended for sale and is to be sent or conveyed from one province to another; or
(d) register an establishment authorizing a person to conduct a prescribed activity in the establishment in relation to a prescribed food that is intended for sale and is to be sent or conveyed from one province to another.
Terms and conditions —regulations
(2) A registration or licence is deemed to be subject to the terms and conditions that are prescribed from time to time.
Terms and conditions —Minister
(3) A registration or licence is subject to the additional terms and conditions that the Minister considers appropriate.
Obligation to comply
(4) The person who is authorized to conduct an activity under subsection (1) shall comply with the terms and conditions to which the registration or licence, as the case may be, is subject.
Clinical Trial Authorizations
Issuance
18.2 (1) Subject to the regulations, the Minister may, on application, issue a clinical trial authorization to a person in respect of therapeutic products.
Terms and conditions —regulations
(2) The clinical trial authorization is deemed to be subject to the terms and conditions that are prescribed from time to time.
Terms and conditions —Minister
(3) The Minister may issue the clinical trial authorization subject to the additional terms and conditions that he or she considers appropriate.
Obligation to comply
(4) The holder of the clinical trial authorization shall comply with the terms and conditions to which the authorization is subject.
No transfer without consent
18.3 A clinical trial authorization is not transferable without the Minister’s consent.
Amendment
18.4 (1) Subject to the regulations, the Minister may, on his or her own initiative or on the application of the holder of the authorization, amend a clinical trial authorization or the terms and conditions to which it is subject other than a prescribed term or condition.
Representations
(2) The Minister may not make an amendment on his or her own initiative unless he or she first gives the holder an opportunity to make representations to the Minister.
Suspension —contravention or prevention of injury
18.5 (1) Subject to the regulations, the Minister may, after giving the holder of the authorization an opportunity to make representations, suspend a clinical trial authorization if the Minister is of the opinion that
(a) the holder has contravened this Act or the regulations in respect of a therapeutic product to which the authorization relates;
(b) the holder has contravened a term or condition of the authorization; or
(c) the suspension is necessary to prevent injury to the health of a clinical trial subject or a person who is involved in the clinical trial.
Immediate suspension
(2) Subject to the regulations, the Minister may, without having to give the holder of the authorization an opportunity to make representations, suspend a clinical trial authorization if the Minister is of the opinion that an immediate suspension is necessary to respond to a serious and imminent risk of injury to the health of a clinical trial subject or a person who is involved in the clinical trial.
Revocation —contravention
18.6 (1) Subject to the regulations, the Minister may, after giving the holder of the authorization an opportunity to make representations, revoke a clinical trial authorization if the Minister believes on reasonable grounds that
(a) the holder has contravened this Act or the regulations in respect of a therapeutic product to which the authorization relates; or
(b) the holder has contravened a term or condition of the authorization.
Revocation —unacceptable risks
(2) Subject to the regulations, the Minister may — after requesting the holder of the authorization to establish within the time specified by the Minister that the risks, to the health of a clinical trial subject or to a person who is involved in the clinical trial, that are associated with the therapeutic product to which the authorization relates are not unacceptable — revoke a clinical trial authorization if the Minister is of the opinion that the holder has failed to do so.
Revocation with consent
(3) The Minister may revoke a clinical trial authorization with the consent of its holder.
Market Authorizations
Issuance
18.7 (1) Subject to the regulations, the Minister may, on application, issue a market authorization to a person in respect of a therapeutic product other than a designated therapeutic product if the Minister is of the opinion that the person has established that the benefits that are associated with the therapeutic product outweigh the risks.
Terms and conditions —regulations
(2) The market authorization is deemed to be subject to the terms and conditions that are prescribed from time to time.
Terms and conditions —Minister
(3) The Minister may issue the market authorization subject to the additional terms and conditions that he or she considers appropriate.
Obligation to comply
(4) The holder of the market authorization shall comply with the terms and conditions to which the authorization is subject.
No transfer without consent
18.8 A market authorization is not transferable without the Minister’s consent.
Amendment
18.9 (1) Subject to the regulations, the Minister may, on his or her own initiative or on application of the holder of the authorization, amend a market authorization or the terms and conditions to which it is subject other than a prescribed term or condition.
Representations
(2) The Minister may not make an amendment on his or her own initiative unless he or she first gives the holder a reasonable opportunity to make representations to the Minister.
Suspension —contravention or risks
19. (1) Subject to the regulations, the Minister may, after giving the holder of the authorization an opportunity to make representations, suspend a market authorization if the Minister is of the opinion that
(a) the holder has contravened this Act or the regulations in respect of a therapeutic product to which the authorization relates;
(b) the holder has contravened a term or condition of the authorization; or
(c) the risks that are associated with the therapeutic product to which the authorization relates outweigh the benefits.
Immediate suspension
(2) Subject to the regulations, the Minister may, without having to give the holder of the authorization an opportunity to make representations, suspend a market authorization if the Minister is of the opinion that an immediate suspension is necessary to respond to a serious and imminent risk of injury to health.
Revocation —contravention
19.1 (1) Subject to the regulations, the Minister may, after giving the holder of the authorization an opportunity to make representations, revoke a market authorization if the Minister believes on reasonable grounds that
(a) the holder has contravened this Act or the regulations in respect of a therapeutic product to which the authorization relates; or
(b) the holder has contravened a term or condition of the authorization.
Revocation —benefits outweighing risks not established
(2) Subject to the regulations, the Minister may — after requesting the holder of the authorization to establish within the time specified by the Minister that the benefits that are associated with the therapeutic product to which the authorization relates outweigh the risks — revoke a market authorization if the Minister is of the opinion that the holder has failed to do so.
Revocation with consent
(3) The Minister may revoke a market authorization with the consent of its holder.
Establishment Licences
Issuance
19.2 (1) Subject to the regulations, the Minister may, on application, issue an establishment licence to a person authorizing them to conduct, in respect of the one or more therapeutic products or classes of therapeutic products specified in the licence, the specified controlled activity in the specified premises.
Terms and conditions —regulations
(2) The establishment licence is deemed to be subject to the terms and conditions that are prescribed from time to time.
Terms and conditions —Minister
(3) The Minister may issue the establishment licence subject to the additional terms and conditions that he or she considers appropriate.
Obligation to comply
(4) The holder of the establishment licence shall comply with the terms and conditions to which the licence is subject.
Period of validity
19.3 An establishment licence is valid for the period that the Minister specifies in it.
No transfer without consent
19.4 An establishment licence is not transferable without the Minister’s consent.
Amendment
19.5 (1) Subject to the regulations, the Minister may, on his or her own initiative or on the application of the holder of the licence, amend an establishment licence or the terms and conditions to which it is subject other than a prescribed term or condition.
Representations
(2) The Minister may not make an amendment on his or her own initiative unless he or she first gives the holder a reasonable opportunity to make representations to the Minister.
Suspension —contravention or prevention of injury
19.6 (1) Subject to the regulations, the Minister may, after giving the holder of the licence an opportunity to make representations, suspend an establishment licence if the Minister is of the opinion that
(a) the holder has contravened this Act or the regulations in relation to an activity that the holder is authorized to conduct under the licence;
(b) the holder has contravened a term or condition of the licence; or
(c) the suspension is necessary to prevent injury to health.
Immediate suspension
(2) Subject to the regulations, the Minister may, without having to give the holder of the licence an opportunity to make representations, suspend an establishment licence if the Minister is of the opinion that an immediate suspension is necessary to respond to a serious and imminent risk of injury to health.
Revocation —contravention
19.7 (1) Subject to the regulations, the Minister may, after giving the holder of the licence an opportunity to make representations, revoke an establishment licence if the Minister believes on reasonable grounds that
(a) the holder has contravened this Act or the regulations in relation to an activity that the holder is authorized to conduct under the licence; or
(b) the holder has contravened a term or condition of the licence.
Revocation —risk of injury to health
(2) Subject to the regulations, the Minister may — after requesting the holder of the licence to establish within the time specified by the Minister that allowing the licence to continue in force would not present a risk of injury to health — revoke an establishment licence if the Minister is of the opinion that the holder has failed to do so.
Revocation —consent
(3) The Minister may revoke an establishment licence with the consent of its holder.
Powers of the Minister
Power to require information
19.8 Subject to the regulations, the Minister may direct the holder of a clinical trial authorization, market authorization or establishment licence to provide the Minister with the information that is in their control and that the Minister considers necessary for the administration of this Act.
Power to require tests or studies, etc.
19.9 Subject to the regulations, the Minister may direct the holder of a market authorization or establishment licence to
(a) compile information, conduct tests or studies or monitor experience in respect of a therapeutic product to which the authorization or licence relates for the purpose of obtaining additional information about its effects on health or safety; or
(b) report the information or the results of the tests, studies or monitoring to the Minister.
Power to require information — after discontinuance or revocation
20. If the clinical trials that are authorized by a clinical trial authorization are discontinued or the clinical trial authorization is revoked, the Minister may, subject to the regulations, direct the holder or former holder of the authorization to provide the Minister with the information that they receive about the therapeutic product to which the authorization relates.
Power to require labels to be revised
20.1 Subject to the regulations, the Minister may direct the holder of a clinical trial authorization, market authorization or establishment licence to revise the label of a therapeutic product to which the authorization or licence relates to reflect the information that the Minister considers necessary to prevent injury to health.
Power to require reassessment
20.2 Subject to the regulations, the Minister may direct the holder of a market authorization to conduct a reassessment of the therapeutic product to which the authorization relates or provide the Minister with the results of the reassessment within the time specified by the Minister.
Power to disclose risk information
20.3 The Minister may disclose to the public information about the risks or benefits that are associated with a therapeutic product.
GENERAL PROVISIONS
Consultation
Committees
20.4 (1) The Minister may establish committees for the purpose of seeking advice.
Remuneration and travel and living expenses
(2) Committee members may be paid remuneration up to the amount that is fixed by the Governor in Council and are entitled to the reasonable travel and living expenses that they incur while performing their duties away from their ordinary place of residence.
Information
Required information — serious risk
20.5 If the Minister is of the opinion that a food, therapeutic product or cosmetic may present a serious risk to human health, the Minister may direct a person to provide the Minister with information that is in the person’s control and that is necessary for the Minister to determine whether it presents that risk.
Required information — s. 19(1) of the Canadian Food Inspection Agency Act
20.6 The Minister may direct a person referred to in subsection 19(1) of the Canadian Food Inspection Agency Act to provide the Minister with information that is in the person’s control and that is necessary for the purposes of that subsection.
Required information — health care institutions
20.7 A health care institution that belongs to a prescribed class of health care institutions shall provide the Minister with information about the adverse reactions of individuals who receive medical treatment from them that are associated with the use of therapeutic products.
Register
20.8 The Minister is to establish and maintain a publicly accessible register in which is to be kept the prescribed information about therapeutic products.
Personal Information
Disclosure — serious risk
20.9 The Minister may disclose personal information to a person or government that carries out functions relating to the protection or promotion of human health without the consent of the individual to whom the personal information relates if the disclosure is necessary to identify or respond to a serious risk to human health. The exercise of the Minister’s power is subject to the making of regulations respecting the disclosure of personal information.
Disclosure — foods
21. The Minister may disclose personal information to a person or government that carries out functions relating to the protection or promotion of human health without the consent of the individual to whom the personal information relates if the disclosure is necessary for the purposes of subsection 19(1) of the Canadian Food Inspection Agency Act.
Confidential Business Information
Disclosure — agreement
21.1 The Minister may disclose confidential business information to a government or to the following persons, without the consent of the person to whose business or affairs the information relates and without notifying that person, for a purpose that is related to the protection or promotion of the health or safety of the public, if the government or person agrees in writing to maintain the confidentiality of the information:
(a) a person from whom the Minister seeks advice; and
(b) a person who carries out functions relating to the assessment of the safety of a food, therapeutic product or cosmetic, of the nutritional quality of a food, of the effectiveness, cost effectiveness or appropriate use of a therapeutic product or cosmetic or of the risks or benefits associated with a therapeutic product or cosmetic.
Disclosure — risk
21.2 (1) The Minister may, without the consent of the person to whose business or affairs the information relates and without notifying that person, disclose confidential business information if
(a) the information is about a food, therapeutic product or cosmetic that presents a serious and imminent risk of injury to health; or
(b) the disclosure is necessary for the purposes of subsection 19(1) of the Canadian Food Inspection Agency Act.
Disclosure — other confidential business information
(2) The Minister may, without the consent of the person to whose business or affairs the information relates, disclose other confidential business information if the disclosure is authorized by the regulations.
ADMINISTRATION AND ENFORCEMENT
Inspection
9. Subsection 22(1) of the Act is replaced by the following:
Inspectors
22. (1) The Minister may designate an individual as an inspector for the purpose of the administration and enforcement of this Act and the regulations.
R.S., c. 31 (1st Supp.), s. 11; R.S., c. 27 (3rd Supp.), s. 2; 1997, c. 6, s. 64
10. Section 23 to 28 of the Act are replaced by the following:
Authority to enter a place
23. (1) Subject to subsection 23.1(1), an inspector may, for the purpose of verifying compliance or preventing non-compliance with this Act or the regulations, at any reasonable time enter a place, including a conveyance, in which the inspector believes on reasonable grounds that an activity that is governed by this Act or the regulations is conducted or a document relating to the administration of this Act is located.
Powers of inspectors
(2) The inspector may
(a) examine or test anything — and take samples free of charge of an article to which this Act or the regulations apply — that is found in the place;
(b) open a receptacle or package that is found in the place;
(c) examine a document that is found in the place, make a copy of it or take an extract from it;
(d) seize and detain for any time that may be necessary
(i) an article to which this Act or the regulations apply that is found in the place, or
(ii) a conveyance;
(e) direct the owner or the person having possession, care or control of a conveyance to move it;
(f) use or cause to be used a computer or other device that is at the place to examine a document that is contained in or available to a computer system or reproduce it or cause it to be reproduced in the form of a printout or other intelligible output and remove the output for examination or copying;
(g) use or cause to be used copying equipment that is at the place and remove the copies for examination;
(h) take photographs or make recordings or sketches; and
(i) direct the owner or person in charge of the place or a person who conducts an activity that is governed by this Act or the regulations at the place
(i) to establish their identity to the inspector’s satisfaction, or
(ii) to stop or start the activity.
Assistance and information to be given to inspector
(3) The owner or person in charge of the place and a person found in the place shall give an inspector who is carrying out their functions all reasonable assistance and provide them with the information that they may reasonably require.
Private property
(4) An inspector who is carrying out their functions may enter on or pass through or over private property without being liable for doing so and without the owner of the property having the right to object to that use of the property.
Dwelling-house
23.1 (1) If the place referred to in subsection 23(1) is a dwelling-house, an inspector may not enter it without the consent of the occupant except under the authority of a warrant issued under subsection (2).
Authority to issue warrant
(2) A justice of the peace may, on ex parte application, issue a warrant authorizing, subject to the conditions specified in the warrant, the inspector named in it to enter a dwelling-house if the justice of the peace is satisfied by information on oath that
(a) the dwelling-house is a place referred to in subsection 23(1);
(b) entry to the dwelling-house is necessary for a purpose referred to in subsection 23(1); and
(c) entry to the dwelling-house was refused or there are reasonable grounds to believe that it will be refused.
Use of force
(3) In executing a warrant issued under subsection (2), the inspector may not use force unless the inspector is accompanied by a peace officer and the use of force is authorized in the warrant.
Telewarrant
(4) If an inspector believes that it would not be practical to appear personally to make an application for a warrant under subsection (2), a warrant may be issued by telephone or other means of telecommunication on application submitted by telephone or other means of telecommunication and section 487.1 of the Criminal Code applies for that purpose, with the necessary modifications.
Restriction on movement
23.2 An inspector may direct the owner or person having possession, care or control of an article to which this Act or the regulations apply to not move it — or to restrict its movement — for as long as is in the opinion of the inspector necessary for the purposes referred to in subsection 23(1).
Seizure
Disposition of things seized
23.3 An inspector who seizes a thing under this Act may
(a) on notice to and at the expense of its owner — or the person having possession, care or control of the thing at the time of its seizure — store it or move it to another place;
(b) direct its owner or the person having possession, care or control of it at the time of its seizure to store the thing or move it to another place at their expense; or
(c) if the inspector believes on reasonable grounds that the thing could be injurious to human health,
(i) dispose of it on notice to and at the expense of its owner or the person having possession, care or control of it at the time of its seizure, or
(ii) direct its owner or the person having possession, care or control of it at the time of its seizure to dispose of it at their expense.
Release of seized things
23.4 An inspector who seizes a thing under this Act shall release it if they are satisfied that the provisions of this Act and the regulations with respect to it have been complied with.
Forfeiture
Thing unclaimed
23.5 (1) A seized thing is, at Her election, forfeited to Her Majesty in right of Canada if
(a) within 60 days after the seizure, no person is identified as its owner or as a person who is entitled to possess it; or
(b) within 60 days after the day on which the owner or person who is entitled to possess it is notified that the inspector has released it, they do not claim it.
Exception
(2) Subsection (1) does not apply if proceedings are instituted in respect of an offence that relates to the seized thing.
Disposition
(3) A seized thing that is forfeited may be disposed of at the expense of its owner or the person who was entitled to possess it at the time of its seizure.
Conviction for offence
23.6 (1) If a person is convicted of an offence under this Act, the court may order that a seized thing by means of or in relation to which the offence was committed be forfeited to Her Majesty in right of Canada.
Disposition
(2) A seized thing that is forfeited may be disposed of at the expense of its owner or the person who was entitled to possess it at the time of its seizure.
Consent
23.7 If the owner of a seized thing consents to its forfeiture, it is forfeited to Her Majesty in right of Canada and may be disposed of at the owner’s expense.
Other Measures
Measures
23.8 (1) If an inspector believes on reasonable grounds that there is a contravention of this Act or the regulations, the inspector may, among other things, direct a person to
(a) stop doing something that is in contravention of this Act or the regulations or cause it to be stopped; or
(b) take a measure that is necessary to identify or respond to a risk of injury to health that is related to the activity that is the subject of the contravention.
Operation
(2) The inspector may direct that a requirement established under subsection (1) apply for a specified period or until the inspector is satisfied that no further contravention is likely to take place.
Court has same powers as inspector
(3) If a person is charged with an offence relating to the contravention, the court may confirm, vary or rescind the requirement.
Removal of unlawful imports
23.9 An inspector who believes on reasonable grounds that a food, therapeutic product or cosmetic that was imported for sale does not meet the requirements established under this Act, or was imported for sale in contravention of a requirement established under this Act, may direct its owner or importer or the person having possession, care or control of it to remove it from Canada at their expense even if the inspector does not seize it.
Recall — therapeutic product or cosmetic
24. (1) If, in the opinion of the Minister, a therapeutic product or cosmetic presents a serious or imminent risk of injury to health, the Minister may direct a person who sells it to recall it and if necessary to have it sent to the place designated by the Minister.
Prohibition
(2) Subject to subsection (3), no person shall sell a therapeutic product or cosmetic that the Minister directs a person to recall.
Exception to recall
(3) The Minister may authorize a person to sell a therapeutic product or cosmetic even if the Minister has directed a person to recall it.
Injunction
24.1 (1) If, on the application of the Minister, it appears to a court of competent jurisdiction that a person did or is about or likely to do an act or thing that constitutes or is directed toward the commission of an offence under this Act, the court may order the person named in the application to
(a) refrain from doing an act or thing that it appears to the court may constitute or be directed toward the commission of an offence under this Act;
(b) do an act or thing that it appears to the court may prevent the commission of an offence under this Act; or
(c) take a measure referred to in subsection 23.8(1).
Notice
(2) No injunction shall be issued under subsection (1) unless 48 hours’ notice is given to the person named in the application or the urgency of the situation is such that giving notice would not be in the public interest.
Obstruction and false statements
24.2 (1) No person shall obstruct or hinder, or knowingly make a false or misleading statement either orally or in writing to, an inspector who is carrying out their functions.
Interference
(2) Except with the authority of an inspector, no person shall remove, alter or interfere in any way with anything seized under this Act.
Documents
Maintenance and production of documents
25. Subject to section 26, a person who is required to maintain documents shall keep them in Canada at a prescribed place, or at the person’s place of business if there is no prescribed place, and shall on request provide an inspector with them.
Outside Canada
26. The Minister may, subject to the terms and conditions that he or she specifies, exempt a person or class of persons from a requirement to keep documents in Canada if he or she considers it unnecessary or impracticable for them to keep them in Canada.
Prohibition
27. No person shall falsify a document that they are required to maintain or provide or — with intent to mislead — alter, destroy, erase or obliterate one.
Analysis
Analysts
28. The Minister may designate an individ- ual as an analyst for the purpose of the administration and enforcement of this Act and the regulations.
1994, c. 47, s. 117; 1999, c. 33, s. 347
11. (1) Subsections 30(1) to (3) of the Act are replaced by the following:
Regulations
30. (1) The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, including regulations
(a) declaring that foods, therapeutic products or cosmetics are adulterated if a prescribed substance or class of prescribed substances is present or was added to them or extracted or omitted from them;
(b) defining, in respect of a food, therapeutic product or cosmetic or a class of foods, therapeutic products or cosmetics, “collect”, “manufacture”, “prepare”, “prescription”, “preserve”, “process”, “product monograph”, “test” or “wholesale”;
(c) specifying, for the purposes of the definition “confidential business information” in section 2, the business information that is not confidential business information and respecting the circumstances in which business information ceases to be confidential business information;
(d) subject to subsection (1.1), designating therapeutic products or classes of therapeutic products as designated therapeutic products, including designating them as such if they are used only by a specified class of persons;
(e) respecting the preparation or retention of anything that the Governor in Council considers necessary for the administration or enforcement of this Act or the regulations — including specifying the documents or classes of documents that are to be prepared or retained and requiring a class of persons to prepare or retain documents or to provide the Minister or an inspector with them or with access to them — or specifying the period for which they are to be kept;
(f) requiring persons who sell or import for sale foods, therapeutic products or cosmetics to establish tracing systems that would enable them to ascertain their place of origin or destination, recall them or provide persons who could be affected by them with information;
(g) respecting the tracing systems that are required by regulations made under paragraph (f);
(h) respecting
(i) the labelling, packaging or advertising — or the offering or exposing for sale — of foods, therapeutic products or cosmetics,
(ii) the size, dimensions or fill of, or other specifications for, packages of foods, therapeutic products or cosmetics,
(iii) the sale or the conditions of sale of a food, therapeutic product or cosmetic, or
(iv) the use of a substance as an ingredient in a food, therapeutic product or cosmetic;
(i) establishing — in respect of a food, therapeutic product or cosmetic — a standard of composition, strength, potency, purity, quality or another property;
(j) respecting the importation of foods, therapeutic products or cosmetics;
(k) respecting the manufacturing, collecting, processing, preparation, preserving, storing, conveying or testing of foods, therapeutic products or cosmetics;
(l) establishing pre-clearance or in-transit requirements in respect of a food, therapeutic product or cosmetic that is or is to be imported into Canada or in respect of a package, document, label or other thing that is imported with it;
(m) respecting the recognition of foreign inspection bodies, foreign inspection or preparation systems, foreign preparation facilities or foreign inspection results;
(n) establishing requirements for quality management programs, quality control programs, safety programs or other similar programs relating to foods, therapeutic prod- ucts or cosmetics;
(o) specifying, for the purposes of subsection 5(1) and sections 14 and 16.1, what is considered to be a manner that is false, misleading or deceptive or is likely to create an erroneous impression;
(p) respecting the conduct of a controlled activity;
(q) respecting the designation of prescription therapeutic products;
(r) respecting the distribution or the conditions of distribution of samples of a therapeutic product;
(s) specifying the terms and conditions to which registrations or licences referred to in section 18.1, clinical trial authorizations, market authorizations or establishment licences are subject;
(t) respecting the registration of persons or establishments or the issuance of licences to persons under section 18.1 and respecting applications for registration or for licences or the amendment, suspension, revocation, reinstatement or transfer of registrations or licences;
(u) respecting the manner in which information, notices or documents that are required under this Act are to be sent;
(v) in the case of information, notices or documents that are required to be sent in electronic form,
(i) specifying the persons or classes of persons who may transmit them in elec- tronic form,
(ii) respecting signatures in electronic or other form and respecting their execution, adoption or authorization in a manner that is to have the same effect as a signature, or
(iii) respecting the time at which or the circumstances in which information, notices or documents are deemed to be sent or received or the place at which they are deemed to be sent or received;
(w) respecting the conduct of clinical trials;
(x) establishing classes of clinical trial authorizations, market authorizations or establishment licences and specifying the class or classes of therapeutic products to which each class relates;
(y) respecting applications for or the issuance, amendment, suspension, revocation or transfer of clinical trial authorizations, market authorizations or establishment licences;
(z) respecting the designation or recognition of persons who are authorized to certify compliance with requirements or standards in relation to clinical trial authorizations, market authorizations or establishment licences and respecting their functions in relation to that certification;
(z.1) specifying the circumstances in which the Minister is bound or ceases to be bound by statements made in writing to applicants for or holders of clinical trial authorizations, market authorizations or establishment licences;
(z.2) respecting the exercise of the Minister’s powers under sections 19.8 to 20.3, 20.5 and 20.6 or the circumstances in which the Minister may exercise those powers;
(z.3) respecting the reassessments referred to in section 20.2;
(z.4) respecting the membership, functions or operation of committees established under subsection 20.4(1);
(z.5) respecting public consultations in respect of foods, therapeutic products or cosmetics;
(z.6) for the purposes of section 20.7, respecting the information that is to be provided by health care institutions;
(z.7) respecting the collection, use or disclosure of personal information or confidential business information by the Minister, including its disclosure to the public;
(z.8) respecting the exercise of analysts’ or inspectors’ functions or the circumstances in which an inspector may exercise their powers;
(z.9) respecting the taking of samples or the seizure, detention, forfeiture or disposition of anything under this Act;
(z.10) respecting the measures referred to in sections 23.2, 23.8 and 23.9;
(z.11) respecting, for the purposes of section 24, the recall of a therapeutic product or cosmetic or the sale of one that was recalled;
(z.12) respecting the requirements for the application of section 37, including the labelling, packaging, storage or advertising of a food, therapeutic product or cosmetic that is manufactured for the purpose of being exported;
(z.13) exempting from the application of this Act or the regulations or a provision of this Act or the regulations a food, therapeutic product or cosmetic or class of foods, therapeutic products or cosmetics and fixing the conditions of the exemption;
(z.14) exempting a person or class of persons from the application of this Act or the regulations or a provision of this Act or the regulations in relation to a food, therapeutic product or cosmetic or class of foods, therapeutic products or cosmetics and fixing the conditions of the exemption;
(z.15) exempting an activity or class of activities from the application of this Act or the regulations or a provision of this Act or the regulations in relation to a food, therapeutic product or cosmetic or class of foods, therapeutic products or cosmetics and fixing the conditions of the exemption;
(z.16) respecting the assessment of the effect on the environment or on human life or health of the release into the environment of a food, therapeutic product or cosmetic and the measures to take before importing or selling a food, therapeutic product or cosmetic that was assessed; and
(z.17) prescribing anything that by this Act is to be prescribed.
Restriction — designated therapeutic products
(1.1) A regulation may be made under paragraph (1)(d) only if the Governor in Council is satisfied that the therapeutic product is one that by its nature does not need to be the subject of an assessment of its benefits and risks.
Restriction — indefinite retention
(1.2) In specifying a period for the purposes of paragraph (1)(e), the Governor in Council may specify an indefinite period in relation to a class of documents or other things only if, in the opinion of the Governor in Council, the indefinite retention of those documents or other things is required in order to enable the identification or tracking of transmissible diseases or disease agents.
Regulations — drugs manufactured outside Canada
(2) Without limiting or restricting the authority conferred by any other provisions of this Act for carrying into effect the purposes and provisions of this Act, the Governor in Council may make the regulations — governing, regulating or prohibiting the sale or importation of a drug or class of drugs that is manufactured outside Canada — that the Governor in Council considers necessary for the protection of the public in relation to the safety and quality of a drug or class of drugs.
Regulations — North American Free Trade Agreement and WTO Agreement
(3) Without limiting or restricting the authority conferred by any other provisions of this Act for carrying into effect the purposes and provisions of this Act, the Governor in Council may make the regulations that the Governor in Council considers necessary for the purpose of implementing, in relation to drugs, Article 1711 of the North American Free Trade Agreement or paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the WTO Agreement.
2004, c. 23, s. 2
(2) Subsection 30(5) of the Act is replaced by the following:
Regulations — General Council Decision
(5) Without limiting or restricting the authority conferred by any other provisions of this Act for carrying into effect the purposes and provisions of this Act, the Governor in Council may make the regulations that the Governor in Council considers necessary for the purpose of implementing the General Council Decision.
(3) Section 30 of the Act is amended by adding the following after subsection (6):
Externally produced documents
(7) A regulation may incorporate by reference documents produced by a person or body — other than the Minister or the Canadian Food Inspection Agency — including
(a) an organization established for the purpose of writing standards, including an organization accredited by the Standards Council of Canada;
(b) an industrial or trade organization; or
(c) a government.
Reproduced or translated documents
(8) A regulation may incorporate by reference documents that the Minister reproduces or translates from documents produced by a person or body other than the Minister or the Canadian Food Inspection Agency
(a) with any adaptations of form or reference that would facilitate their incorporation into the regulation; or
(b) in a form that sets out only the parts of them that apply for the purposes of the regulation.
Jointly produced documents
(9) A regulation may incorporate by reference documents that the Minister or the Canadian Food Inspection Agency produces jointly with another government for the purpose of harmonizing the regulation with other laws.
Internally produced standards
(10) A regulation may incorporate by reference technical or explanatory documents that the Minister or the Canadian Food Inspection Agency produces, including
(a) specifications, classifications, illustrations, graphs or other information of a technical nature; and
(b) test methods, procedures, operational standards, safety standards or performance standards of a technical nature.
Incorporation as amended from time to time
(11) Documents may be incorporated by reference as amended from time to time.
For greater certainty
(12) Subsections (7) to (11) are for greater certainty and do not limit any authority to make regulations incorporating documents by reference that exists apart from those subsections.
2004, c. 15, s. 66
12. Subsections 30.1(3) and (4) of the Act are replaced by the following:
Exemption from Statutory Instruments Act
(4) An interim order is exempt from the application of sections 3 and 9 of the Statutory Instruments Act.
13. (1) Subsection 30.2(1) of the Act, as enacted by section 3 of chapter 42 of the Statutes of Canada, 2005, is replaced by the following:
Interim marketing authorization
30.2 (1) The Minister may issue an interim marketing authorization for a food that provides for any matter referred to in subsection (2), and may, by order, exempt the food from the application, in whole or in part, of sections 5, 6 and 6.1 and the applicable requirements of the regulations, if the Minister determines that the food would not be harmful to the health of the purchaser or consumer.
(2) Subsections 30.2(5) and (6) of the Act, as enacted by section 3 of chapter 42 of the Statutes of Canada, 2005, are replaced by the following:
Exemption from Statutory Instruments Act
(5) An authorization, a notice cancelling an authorization and an order exempting a food are exempt from the application of sections 3 and 9 of the Statutory Instruments Act.
When effective
(6) An authorization, a notice cancelling an authorization and an order exempting a food have effect from the time that they are made. An authorization ceases to have effect on the earliest of
(a) the day on which a notice cancelling the authorization is made,
(b) the day on which a regulation made under this Act, that has the same effect as the authorization, comes into force, and
(c) two years after the day on which the authorization is made.
Deeming
(7) For the purpose of a provision of this Act other than this section, a reference to regulations made under this Act is deemed to include authorizations and a reference to a regulation made under a specified provision of this Act is deemed to include a reference to the portion of an authorization containing a provision that may be contained in a regulation made under the specified provision.
1997, c. 6, ss. 66(1) and 91
14. The heading before section 31 and sections 31 to 32 of the Act are replaced by the following:
Offences
Contravention
31. (1) A person who contravenes a provision of this Act or the regulations, does not do something that the Minister or an inspector directs them to do under this Act or does something that the Minister or an inspector directs them not to do under this Act is guilty of an offence and liable
(a) on conviction on indictment, to a fine of not more than $5,000,000 or to imprisonment for a term of not more than two years or to both; or
(b) on summary conviction, for a first offence to a fine of not more than $250,000 or to imprisonment for a term of not more than six months or to both and, for a subsequent offence, to a fine of not more than $500,000 or to imprisonment for a term of not more than 18 months or to both.
Due diligence
(2) Due diligence is a defence in a prosecution for an offence under subsection (1).
Contravention — wilfully or recklessly
(3) A person who, wilfully or recklessly, contravenes a provision of this Act or the regulations, does not do something that the Minister or an inspector directs them to do under this Act or does something that the Minister or an inspector directs them not to do under this Act is guilty of an offence and is 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 of not more than five years or to both; or
(b) on summary conviction, for a first offence to a fine of not more than $500,000 or to imprisonment for a term of not more than 18 months or to both and, for a subsequent offence, to a fine of not more than $1,000,000 or to imprisonment for a term of not more than two years or to both.
Sentencing considerations
(4) A court that imposes a sentence shall take into account, in addition to 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 food, therapeutic product or cosmetic.
Parties to offence
(5) If a person other than an individual commits an offence under this Act, any of the person’s directors, officers, agents or mandataries who directs, authorizes, assents to, acquiesces in 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.
Proof of offence
(6) In a prosecution for an offence under this Act, it is sufficient proof of the offence to establish that it was committed by an employee, agent or mandatary of the accused, even if the employee, agent or mandatary is not identified or prosecuted for the offence.
Continuing offence
31.1 If an offence under this Act is committed or continued on more than one day, it constitutes a separate offence for each day on which it is committed or continued.
Limitation period
32. (1) A prosecution for a summary conviction offence under this Act may be instituted at any time within two years after the time the subject-matter of the prosecution becomes known to the Minister.
Minister’s certificate
(2) A document purporting to be issued by the Minister, certifying the day on which the subject-matter of the 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 it and is, in the absence of evidence to the contrary, proof of the matters asserted in it.
15. The portion of subsection 34(1) of the Act before paragraph (a) is replaced by the following:
Want of knowledge
34. (1) Subject to subsection (2), in a prosecution for the sale of an article in contravention of this Act or the regulations if the accused proves to the satisfaction of the court or judge that
1993, c. 34, s. 73; 1996, c. 19, s. 79; 2004, c. 23, s. 3
16. Sections 36 and 37 of the Act are replaced by the following:
Proof as to manufacturer or packager
36. (1) In a prosecution for an offence under this Act, proof that a package containing an article to which this Act or the regulations apply bears 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 to which this Act or the regulations apply was manufactured or packaged by the person whose name or address appears on the package.
Certified copies
(2) In a prosecution for an offence under this Act, a copy of a document, or of an extract that was taken from a document, that is certified to be a true copy by the inspector who made it under paragraph 23(2)(c) is admissible in evidence and is, in the absence of evidence to the contrary, proof of its contents.
Exports
Exemption — solely for export
37. (1) Subject to the regulations, this Act does not apply to a food, therapeutic product or cosmetic that is manufactured in Canada solely for the purpose of being exported.
No exemption
(2) Despite subsection (1), this Act applies in respect of a therapeutic product that is 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 this Act and the regulations apply to the therapeutic product as though it were a therapeutic product that is to be manufactured and sold for consumption in Canada, unless the regulations provide otherwise.
Assisted Human Reproduction Act
Non-application
38. (1) This Act does not apply to human reproductive material or in vitro embryos that are governed by the Assisted Human Reproduction Act.
Regulations continue to apply
(2) Despite subsection (1), regulations made under subsection 30(1) as it read before the coming into force of this section in respect of human reproductive material continue to apply, as amended from time to time, until they are repealed.
SOR/85-715; SOR/88-252; SOR/89-177 and 503; SOR/90-655; SOR/92-198; SOR/93-64; SOR/94-287; SOR/96-96; SOR/97-560; SOR/99-413 and 414; SOR/2007-120
17. Schedules A to F to the Act are repealed.
TRANSITIONAL PROVISIONS
Par. 23.5(1)(a) of the Food and Drugs Act
18. (1) If anything is seized before the coming into force of paragraph 23.5(1)(a) of the Food and Drugs Act, as enacted by section 10, the day on which it is seized is, for the purposes of that paragraph, deemed to be the day on which that paragraph comes into force.
Par. 23.5(1)(b) of the Food and Drugs Act
(2) If an owner or person who is entitled to possess a seized thing is, before the coming into force of paragraph 23.5(1)(b) of the Food and Drugs Act, as enacted by section 10, notified that the inspector released it, the day on which they are notified that the inspector released it is, for the purposes of that paragraph, deemed to be the day on which that paragraph comes into force.
Clinical trials
19. (1) A person who, before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Division 5 of Part C of the Food and Drug Regulations to sell or import a drug — or to sell or import a natural health product under Part 4 of the Natural Health Products Regulations — for the purposes of a clinical trial is deemed to have been issued a clinical trial authorization in respect of that therapeutic product under that subsection.
Applications
(2) An application under Division 5 of Part C of the Food and Drug Regulations or Part 4 of the Natural Health Products Regulations that is pending or in progress immediately before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for a clinical trial authorization under that subsection.
Clinical testing
20. (1) A person who, before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Division 8 of Part C of the Food and Drug Regulations to sell, for the purposes of clinical testing, a drug for use in human beings or for use in animals that produce food, that are intended for consumption as food or in which the use of the drug could affect human health is deemed to have been issued a clinical trial authorization in respect of that therapeutic product under that subsection.
Applications
(2) An application under Division 8 of Part C of the Food and Drug Regulations that is pending or in progress immediately before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for a clinical trial authorization under that subsection.
Experimental studies
21. (1) A person who, before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Division 8 of Part C of the Food and Drug Regulations to conduct an experimental study in respect of a drug for use in animals that produce food, that are intended for consumption as food or in which the use of the drug could affect human health is deemed to have been issued a clinical trial authorization in respect of that therapeutic product under that subsection.
Applications
(2) An application under Division 8 of Part C of the Food and Drug Regulations that is pending or in progress immediately before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for a clinical trial authorization under that subsection.
Investigational testing
22. (1) A person who, before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Part 3 of the Medical Devices Regulations to sell or import a medical device for the purpose of investigational testing is deemed to have been issued a clinical trial authorization in respect of that therapeutic product under that subsection.
Applications
(2) An application under Part 3 of the Medical Devices Regulations that is pending or in progress immediately before the coming into force of subsection 18.2(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for a clinical trial authorization under that subsection.
Drug identification numbers and notices of compliance
23. (1) A person who, before the coming into force of subsection 18.7(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Division 1 of Part C of the Food and Drug Regulations to sell a drug in respect of which a drug identification number was assigned, or to sell or advertise a drug in respect of which a notice of compliance was issued under Division 8 of that Part C is deemed to have been issued a market authorization in respect of that therapeutic product under that subsection.
Applications
(2) An application under Division 1 or 8 of Part C of the Food and Drug Regulations that is pending or in progress immediately before the coming into force of subsection 18.7(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for a market authorization under that subsection.
Sales and imports — medical devices
24. (1) A person who, before the coming into force of subsection 18.7(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Part 1 of the Medical Devices Regulations to sell or import a medical device is deemed to have been issued a market authorization in respect of that therapeutic product under that subsection.
Applications
(2) An application under Part 1 of the Medical Devices Regulations that is pending or in progress immediately before the coming into force of subsection 18.7(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for a market authorization under that subsection.
Sales — natural health products
25. (1) A person who, before the coming into force of subsection 18.7(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Part 1 of the Natural Health Products Regulations to sell a natural health product is deemed to have been issued a market authorization in respect of that therapeutic product under that subsection.
Applications
(2) An application under Part 1 of the Natural Health Products Regulations that is pending or in progress immediately before the coming into force of subsection 18.7(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for a market authorization under that subsection.
Establishment licences
26. (1) A person who, before the coming into force of subsection 19.2(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Division 1A of Part C of the Food and Drug Regulations to fabricate, package, label, distribute, import, wholesale or test a drug — or under Part 1 of the Medical Devices Regulations to sell or import a medical device — is deemed to have been issued an establishment licence in respect of that activity under that subsection.
Applications
(2) An application under Division 1A of Part C of the Food and Drug Regulations or Part 1 of the Medical Devices Regulations that is pending or in progress immediately before the coming into force of subsection 19.2(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for an establishment licence under that subsection.
Site licences
27. (1) A person who, before the coming into force of subsection 19.2(1) of the Food and Drugs Act, as enacted by section 8, is authorized under Part 2 of the Natural Health Products Regulations to manufacture, package, label or import for sale a natural health product is deemed to have been issued an establishment licence in respect of that activity under that subsection.
Applications
(2) An application under Part 2 of the Natural Health Products Regulations that is pending or in progress immediately before the coming into force of subsection 19.2(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for an establishment licence under that subsection.
Cells, tissues and organs
28. (1) A person who, before the coming into force of subsection 19.2(1) of the Food and Drugs Act, as enacted by section 8, is authorized under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations to import, process, distribute or transplant a cell, tissue or organ is deemed to have been issued an establishment licence in respect of that activity under that subsection.
Applications
(2) An application for registration under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations that is pending or in progress immediately before the coming into force of subsection 19.2(1) of the Food and Drugs Act, as enacted by section 8, is deemed to be an application for an establishment licence under that subsection.