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

Marginal note:Where standard prescribed for device

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

Therapeutic Products

Marginal note:Power to require information — serious risk

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

• Marginal note:Disclosure —  serious risk

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

• Marginal note:Disclosure —  health or safety

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

  • (a) a government;

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

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

• Definition of government

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

  • (a) the federal government;

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

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

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

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

  • (f) an international organization of states.

Marginal note:Modification or replacement — labelling or packaging

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

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

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

  • (a) recall the product; or

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

• Marginal note:Recall order — corrective action

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

• Marginal note:Prohibition — selling

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

• Marginal note:Power to authorize sale

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

• Marginal note:Exception

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

• Marginal note:Contravention of unpublished order

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

Marginal note:Information — serious environmental risk

• 21.301 (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.

• Marginal note:Disclosure — serious environmental 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 to the environment.

• Marginal note:Disclosure —  protection of the environment

  (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 of the environment 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 of the environment, including the assessment and management of risks to the environment.

• Marginal note:Definition of government

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

Marginal note:Labelling or packaging — serious risk to environment

21.302 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.

Marginal note:Minister’s powers — serious risk to environment

• 21.303 (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.

• Marginal note:Subsections 21.3(2) to (6) apply

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

Marginal note:Power to require assessment

21.31 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.

Marginal note:Power to require tests, studies, etc.

21.32 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.

Marginal note:Definition of therapeutic product

21.321 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.

Marginal note:Power — information relating to environmental effects

21.33 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.

Marginal note:Statutory Instruments Act

• 21.4 (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.

• Marginal note:Availability of orders

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

Marginal note:Injunction

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

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

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

• Marginal note:Notice

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

Marginal note:False or misleading information — therapeutic products

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

Marginal note:Terms and conditions of authorizations

21.7 The holder of a therapeutic product authorization shall comply with 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).

Marginal note:Duty to publicize clinical trial information

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

Marginal note:Health care institutions to provide information

• 21.8 (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.

• Marginal note:Definition of 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.

Advanced Therapeutic Products

Marginal note:Prohibited activities

• 21.9 (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.

• Marginal note:Clarification

  (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.

Marginal note:Additions to Schedule G

• 21.91 (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.

• Marginal note:Factors

  (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.

• Marginal note:Deletion from Schedule G

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