Biocides Regulations (SOR/2024-110)

Marginal note:Temporary exemptions — Food and Drug Regulations

• 68 (1) A biocide is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if the biocide is a drug

  • (a) to which a drug identification number has been assigned under the Food and Drug Regulations

    • (i) before the first anniversary of the day on which these Regulations are registered, or

    • (ii) in the case of a drug identification number that is assigned on the basis of an application referred to in subsection (3), on or after that anniversary; and

  • (b) whose drug identification number has not been cancelled.

• Marginal note:End of exemption

  (2) The exemption referred to in subsection (1) ceases to apply on the earliest of

  • (a) the day on which the drug identification number is cancelled under the Food and Drug Regulations;

  • (b) the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

  • (c) the day on which an application for a market authorization for the biocide is withdrawn; and

  • (d) the fifth anniversary of the day on which these Regulations are registered.

• Marginal note:Temporary exemption — pending decision

  (3) A biocide is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if, immediately before the first anniversary of the day on which these Regulations are registered,

  • (a) the biocide is a drug that is the subject of an application for a drug identification number that is made under section C.01.014.1 of the Food and Drug Regulations or of a new drug submission that is filed under section C.08.002 of those Regulations; and

  • (b) no final decision has been made in respect of the application or submission.

• Marginal note:End of exemption

  (4) The exemption referred to in subsection (3) ceases to apply on the earliest of

  • (a) the day on which the Minister makes a final decision in respect of the application or submission under the Food and Drug Regulations;

  • (b) the day on which the application or submission is withdrawn;

  • (c) the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

  • (d) the day on which an application for a market authorization for the biocide is withdrawn; and

  • (e) the fifth anniversary of the day on which these Regulations are registered.