Food and Drug Regulations

C.08.011.1 (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(2) [Repealed, SOR/2021-271, s. 5]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.