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) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.

(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.