Food and Drug Regulations

C.08.009.03 (1) The holder of an establishment licence may import a designated COVID-19 drug if the following conditions are met:

• (a) the Chief Public Health Officer provides the Minister with

  • (i) information indicating that

    • (A) the designated COVID-19 drug is the subject of a new drug submission that was filed under section C.08.002, or

    • (B) an application has been submitted to a foreign regulatory authority to authorize the sale of the designated COVID-19 drug,

  • (ii) the name of the designated COVID-19 drug and a description of it,

  • (iii) the name and contact information of the designated COVID-19 drug’s manufacturer,

  • (iv) information specifying the quantity of the designated COVID-19 drug to be imported,

  • (v) the name and contact information of any holder of an establishment licence who is proposed to be an importer of the designated COVID-19 drug, and

  • (vi) the civic address of the place where the designated COVID-19 drug will be stored after importation;

• (b) the holder provides the Minister with

  • (i) the name and contact information of each fabricator, packager/labeller and tester of the designated COVID-19 drug and the civic address of each building at which the designated COVID-19 drug will be fabricated, packaged/labelled or tested, specifying for each building

    • (A) the activities referred to in Table I to section C.01A.008 that apply to the designated COVID-19 drug,

    • (B) the categories referred to in Table II to that section that apply to the designated COVID-19 drug, and

    • (C) for each category, the dosage form classes, if any, and whether the designated COVID-19 drug will be in a sterile form, and

  • (ii) a certificate from an inspector indicating that each fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 or, alternatively, other evidence establishing that those requirements are met; and

• (c) the holder is one of those specified in the information that the Chief Public Health Officer provides under subparagraph (a)(v).

(2) Paragraph (1)(b) does not apply to the holder of an establishment licence in respect of a building referred to in subparagraph (1)(b)(i) if

• (a) the building is listed in the licence; and

• (b) the information referred to in clauses (1)(b)(i)(A) to (C) that the holder submitted in respect of the building in their application for the licence under section C.01A.005 or in an application to amend the licence under section C.01A.006, has not changed.

(3) If the conditions set out in subsection (1) are met, the Minister shall send a letter to the Chief Public Health Officer to that effect.