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

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Act current to 2020-01-27 and last amended on 2019-06-21. Previous Versions

AMENDMENTS NOT IN FORCE

  • — 2019, c. 29, s. 163

    • R.S., c. 27 (1st Supp.), s. 191; 2014, c. 24, s. 2(3)
      • 163 (1) [In force]

      • (2) The definition therapeutic product authorization in section 2 of the Act is replaced by the following:

        therapeutic product authorization

        therapeutic product authorization means

        • (a) an authorization, including a licence, that

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

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

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

      • (3) [In force]

      • (4) Section 2 of the Act is amended by adding the following in alphabetical order:

        clinical trial

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

        food for a special dietary purpose

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

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

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

  • — 2019, c. 29, s. 166

    • 166 The Act is amended by adding the following after section 3:

      • Prohibition — clinical trials

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

      • Terms and conditions — clinical trial authorizations

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

      • Duty to publicize clinical trial information

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

  • — 2019, c. 29, s. 168(2)

    • 2014, c. 24, s. 3
      • 168 (2) Section 21.71 of the Act is replaced by the following:

        • 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.

  • — 2019, c. 29, s. 172

      • 172 (1) [In force]

      • (2) Subsection 30(1) of the Act is amended by adding the following after paragraph (b):

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

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

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

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

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

      • (3) to (6) [In force]

      • (7) Paragraph 30(1.2)(c) of the Act is replaced by the following:

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

      • 2014, c. 24, s. 6(1)

        (8) Paragraph 30(1.2)(c.1) of the Act is repealed.

      • (9) and (10) [In force]

  • — 2019, c. 29, s. 173(2)

      • 173 (2) Subsection 31.1(2) of the Act is amended by adding the following after paragraph (a):

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

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

  • — 2019, c. 29, s. 174(2)

      • 174 (2) Subsection 31.2(2) of the Act is amended by adding the following after paragraph (a):

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

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

  • — 2019, c. 29, s. 175(2)

      • 175 (2) Subsection 31.4(2) of the Act is amended by adding the following after paragraph (a):

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

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

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