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 designated COVID-19 drug, or amend those 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 under section C.08.002 for the designated COVID-19 drug that contains the statement referred to in paragraph C.08.002(2.1)(a), or

  • (ii) a supplement to a new drug submission referred to in subparagraph (i) that was filed under section C.08.003 for the designated COVID-19 drug; or

• (b) a notice of compliance was issued under section C.08.004 in respect of one of the following that was filed for the designated COVID-19 drug on the basis of a direct or indirect comparison to another designated COVID-19 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 has the same meaning as in section C.08.001.1. (drogue désignée contre la COVID-19)