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

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Act current to 2021-06-28 and last amended on 2021-05-06. Previous Versions

PART IFoods, Drugs, Cosmetics and Devices (continued)

Therapeutic Products (continued)

Marginal note:False or misleading information — therapeutic products

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

  • 2014, c. 24, s. 3

Marginal note:Terms and conditions of authorizations

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

Marginal note:Duty to publicize clinical trial information

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

  • 2014, c. 24, s. 3
  • 2019, c. 29, s. 168

Marginal note:Health care institutions to provide information

 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.

  • 2014, c. 24, s. 5

Advanced Therapeutic Products

Marginal note:Prohibited activities

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

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

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

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

  • 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

  •  (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.

Marginal note:Advanced therapeutic product licence

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

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

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

  • Marginal note:Application

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

  • Marginal note:Terms and conditions

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

Marginal note:Suspension and revocation

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

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

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

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

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

  • Marginal note:Suspension without prior notice

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

Marginal note:Exemption

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

Marginal note:Order — advanced therapeutic products

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

  • Marginal note:Additional content

    (2) The Minister may, in the order,

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

    • (b) establish classes and distinguish among those classes.

  • Marginal note:Compliance with terms and conditions

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

Marginal note:Exemption

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

 
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