Food and Drug Regulations — C.01A.008
C.01A.008 (1) Subject to subsection (1.1) and section C.01A.010, the Minister shall, on receipt of the information and material referred to in sections C.01A.005 to C.01A.007, issue or amend an establishment licence. (1.1) The Minister shall, in ascertaining whether they have received the information and material referred to in sections C.01A.005 to C.01A.007 in relation to an application referred to in subsection C.01A.005(2) or C.01A.006(1.1) that contains the statement referred to in the applicable subsection, also take into consideration the public health need related to the condition described in the List of Conditions that Threaten Public Health , as defined in section C.08.001.1. (1.2) If an application for an establishment licence or to amend such a licence contains a statement referred to in subsection C.01A.005(2) or C.01A.006(1.1) that relates to a condition that is subsequently removed from the List of Conditions that Threaten Public Health , as defined in section C.08.001.1, the Minister may nonetheless issue or amend the licence on the basis of the application. (2) The establishment licence shall indicate (a) each activity set out in Table I to this section that is authorized and the category of drugs set out in Table II to this section for which each activity is authorized, specifying for each activity and category whether sterile dosage forms are authorized; (b) the address of each building in Canada at which a category of drugs set out in Table II to this section is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and (c) in addition to the matters referred to in paragraphs (a) and (b), in the case of an importer, (i) the name and address of each fabricator, packager/labeller and tester from whom the importer is authorized to obtain the drug for import, and (ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs set out in Table II to this section that are authorized, and whether sterile dosage forms are authorized. (d) [Repealed, SOR/2002-368, s. 5] (3) The Minister may indicate in an establishment licence a period for which records shall be retained under Division 2 that, based on the safety profile of the drug or materials, is sufficient to ensure the health of the consumer. (4) When issuing an establishment licence, the Minister may impose terms and conditions on the establishment licence respecting (a) the tests to be performed in respect of a drug, and the equipment to be used, to ensure that the drug is not unsafe for use; and (b) any other matters necessary to prevent risk to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested. TABLE I Item Activities 1 Fabricate 2 Package/label 3 Perform the tests, including any examinations, required under Division 2 4 Distribute as a distributor referred to in paragraph C.01A.003(a) an active ingredient other than (a) an active pharmaceutical ingredient; or (b) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act 5 Distribute as a distributor referred to in paragraph C.01A.003(b) 6 Import 7 Wholesale a drug other than (a) an active pharmaceutical ingredient; or (b) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act TABLE II Item Categories of drugs 1 Pharmaceuticals 1.1 Active ingredients 2 Vaccines 3 [Repealed, SOR/2013-179, s. 2] 4 Drugs that are listed in Schedule D to the Act, other than vaccines 5 Drugs listed in Schedule C to the Act 6 Drugs that are prescription drugs, controlled drugs as defined in section G.01