Food and Drug Regulations

C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a Class B opioid or amend those terms and conditions.

(1.1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a public health emergency drug or amend such terms and conditions if

• (a) a notice of compliance was issued under section C.08.004 in respect of

  • (i) a new drug submission that was filed for the public health emergency drug under section C.08.002 and contains the statement referred to in paragraph C.08.002(2.1)(a), or

  • (ii) a supplement to any new drug submission that was filed for the public health emergency drug under section C.08.003 and contains the statement referred to in paragraph C.08.003(5)(a); or

• (b) a notice of compliance was issued under section C.08.004 in respect of one of the following submissions or supplements that was filed in respect of the public health emergency drug on the basis of a direct or indirect comparison to another public health emergency drug referred to in paragraph (a):

  • (i) a new drug submission under section C.08.002,

  • (ii) an abbreviated new drug submission under section C.08.002.1, or

  • (iii) a supplement to a new drug submission or abbreviated new drug submission under section C.08.003.

(2) The Minister shall notify, in writing, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions.

(3) The following definitions apply in this section.

Class B opioid

Class B opioid means a drug set out in Part B of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. (opioïde de catégorie B)

designated COVID-19 drug

designated COVID-19 drug[Repealed, SOR/2024-238, s. 7]

public health emergency drug

public health emergency drug has the same meaning as in section C.08.001.1. (drogue pour urgence de santé publique)