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

Act current to 2017-05-11 and last amended on 2016-12-12. 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. 5

    • 5 The Act is amended by adding the following after section 21.71:

      • Health care institutions to provide information

        21.8 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, ss. 6(2) to (4)

      • (2) Subsection 30(1.2) of the Act is amended by striking out “and” at the end of paragraph (f) and 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); and

      • (3) Subsection 30(1.2) of the Act is amended by striking out “and” at the end of paragraph (f) and by adding the following after paragraph (g):

        • (h) defining serious adverse drug reaction and medical device incident for the purposes of this Act;

        • (i) respecting the provision by health care institutions referred to in section 21.8 to the Minister of information referred to in that section; and

        • (j) prescribing anything that is to be prescribed under section 21.8.

      • (4) Section 30 of the Act is amended by adding the following after subsection (1.2):

        • Consideration of existing information management systems

          (1.3) Before recommending to the Governor in Council that a regulation be made under paragraph (1.2)(i) or (j), the Minister shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens.

  • — 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

  • — 2014, c. 24, s. 14

    • Subsections 6(2) and (3)
      • 14 (1) If subsection 6(2) comes into force before subsection 6(3), then the English version of subsection 6(3) is amended by replacing “paragraph (f)” with “paragraph (f.3)”.

      • (2) If subsection 6(3) comes into force before subsection 6(2), then the English version of subsection 6(2) is amended by

        • (a) striking out “striking out “and” at the end of paragraph (f) and by”; and

        • (b) striking out “and” at the end of the paragraph (f.3) of the Food and Drugs Act that it enacts.

      • (3) If subsections 6(2) and (3) come into force on the same day, then subsection 6(2) is deemed to have come into force before subsection 6(3) and subsection (1) applies as a consequence.

  • — 2016, c. 9, s. 12

    • 12 The Act is amended by adding the following after section 37:

      • Conditions under which transhipment exempt

        38 This Act does not apply to any packaged food, drug, cosmetic or device if

        • (a) it is manufactured or prepared outside Canada;

        • (b) it is imported solely for the purpose of export and is not sold for consumption or use in Canada; and

        • (c) it meets any other prescribed requirement.

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