C.01A.006 (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the information and documents referred to in section C.01A.005 that relate to the amendment.
(2) An establishment licence must be amended where the licensee proposes
(a) to add an activity or category of drugs, as set out in the tables to section C.01A.008;
(b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category;
(c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and
(d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer,
(i) to add a fabricator, packager/labeller or tester of a drug,
(ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and
(iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category.
- SOR/97-12, s. 5;
- SOR/2011-81, s. 3.
C.01A.007 (1) The Minister may, on receipt of an application for an establishment licence, an amendment to an establishment licence or the review of an establishment licence, require the applicant to submit further details pertaining to the information contained in the application that are necessary to enable the Minister to make a decision.
(2) When considering an application, the Minister may require that
(a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and
(b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug.
- SOR/97-12, s. 5;
- SOR/2011-81, s. 4.
(2) The establishment licence shall indicate
(a) each activity that is authorized and the category of drugs for which each activity is authorized, as set out in the tables to this section, 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 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 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) The Minister may, in addition to the requirements of subsection (2), set out in an establishment licence terms and conditions 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 injury to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested.
Item Activities 1 Fabricate 2 Package/label 3 Perform the tests, including any examinations, required under Division 2 4 Distribute as set out in paragraph C.01A.003(a) a drug that is not an active pharmaceutical ingredient 5 Distribute as set out in paragraph C.01A.003(b) 6 Import 7 Wholesale a drug that is not an active pharmaceutical ingredient 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 subsection G.01.001(1) and narcotics as defined in the Narcotic Control Regulations
- SOR/97-12, s. 5;
- SOR/2000-120, s. 3;
- SOR/2002-368, s. 5;
- SOR/2013-74, s. 6;
- SOR/2013-122, s. 15;
- SOR/2013-179, s. 2.
Annual Licence Review
C.01A.009 (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referrred to in section C.01A.005.
(2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.
- SOR/97-12, s. 5;
- SOR/97-298, s. 1;
- SOR/2011-81, s. 5.
Refusal to Issue
(2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.
(3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall
- SOR/97-12, s. 5.
- Date modified: