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Food and Drug Regulations

Version of section C.08.011.1 from 2022-01-05 to 2023-01-25:

  •  (1) The Minister may issue a letter of authorization to the manufacturer of a new drug authorizing the holder of an establishment licence to import a specified quantity of the new drug for human or veterinary use, if the following conditions are met:

    • (a) the manufacturer provides the following information to the Minister concerning

      • (i) the name of the new drug and details concerning the medical emergency for which the new drug will be imported,

      • (ii) the quantity of the new drug to be imported,

      • (iii) the name of the holder of an establishment licence who will import the new drug,

      • (iv) the civic address of the facility where the new drug is to be stored in Canada, and

      • (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization;

    • (b) the establishment licence authorizes the importation of a new drug in the same category as the one to be imported; and

    • (c) the quantity that is to be imported does not exceed the amount that the Minister determines is likely to be required to address the medical emergency.

  • (2) [Repealed, SOR/2021-271, s. 5]

  • (3) The letter of authorization must contain the following information:

    • (a) the name of the new drug and the medical emergency in respect of which the letter is issued;

    • (b) the quantity of the new drug that may be imported to address the medical emergency;

    • (c) the name of the holder of an establishment licence who is authorized to import the new drug; and

    • (d) the civic address of the facility where the new drug is to be stored in Canada.

  • SOR/2020-212, s. 2
  • SOR/2021-271, s. 5
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