Food and Drug Regulations

C.08.009.03 (1) The holder of an establishment licence may import a public health emergency drug if

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

  • (i) the name and contact information of the holder,

  • (ii) the name and contact information of the public health emergency drug’s manufacturer,

  • (iii) the name of the public health emergency drug and a description of it,

  • (iv) information indicating that the public health emergency drug is the subject of a new drug submission, a supplement to a new drug submission or an application made to a foreign regulatory authority to authorize its sale,

  • (v) information specifying the quantity of the public health emergency drug to be imported, and

  • (vi) the civic address of the place where the public health emergency drug will be stored after it is imported;

• (b) the holder provides the Minister with

  • (i) the name and contact information of each fabricator, packager/labeller and tester of the public health emergency drug and the civic address of each building at which the 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 public health emergency drug,

    • (B) the categories referred to in Table II to that section that apply to the public health emergency drug, and

    • (C) for each of those categories, the dosage form classes, if any, and, in the case of a public health emergency drug that will be sterile, an indication to that effect, and

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

• (c) the public health emergency drug belongs to a category of drugs that are authorized to be imported under the establishment licence.

(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.