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

Act current to 2017-11-06 and last amended on 2017-06-22. Previous Versions

AMENDMENTS NOT IN FORCE

  • — 2014, c. 24, s. 4

    • 4 Section 21.4 of the Act is replaced by the following:

      • 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.

      • 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.

      • Statutory Instruments Act
        • 21.4 (1) For greater certainty, orders made under any of sections 21.1 to 21.32 are not statutory instruments within the meaning of the Statutory Instruments Act.

        • Availability of orders

          (2) The Minister shall ensure that any order made under any of sections 21.1 to 21.32 is publicly available.

  • — 2014, c. 24, s. 6(2), as amended by 2014, c. 24, par. 14(2)(a), (b)(E)

      • (2) Subsection 30(1.2) of the Act is amended by adding the following after paragraph (f):

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

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

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

  • — 2014, c. 24, s. 10

    • 10 The portion of section 31.2 of the Act before paragraph (a) is replaced by the following:

      • Offences relating to therapeutic products

        31.2 Subject to section 31.4, every person who contravenes any provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.32 is guilty of an offence and liable

  • — 2014, c. 24, s. 11

    • 11 The portion of section 31.4 of the Act before paragraph (a) is replaced by the following:

      • Offences — section 21.6 and serious risk

        31.4 A person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.32 is guilty of an offence and liable

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