Food and Drug Regulations

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 applicable information specified in section C.01A.005.

(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.