Food and Drug Regulations

C.01A.005 Subject to section C.01A.006, a person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information:

• (a) the applicant’s name, address and telephone number, and their facsimile number and electronic mail address, if any;

• (b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency;

• (c) each activity set out in Table I to section C.01A.008 for which the licence is requested;

• (d) each category of drugs set out in Table II to section C.01A.008 for which the licence is requested;

• (e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form;

• (f) whether the applicant proposes to carry out a licensed activity in respect of a drug that is a bulk process intermediate;

• (g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building which of those activities and for which category of drugs and, for each category,

  • (i) the dosage form classes, and whether any drugs will be in a sterile dosage form, and

  • (ii) whether any drugs will be bulk process intermediates;

• (h) the address of each building in Canada at which records will be maintained;

• (i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house;

• (j) the drug identification number, if any, or a name that clearly identifies the drug,

  • (i) for each narcotic as defined in the Narcotic Control Regulations or each controlled drug as defined in subsection G.01.001(1) for which the licence is requested, and

  • (ii) for each other drug within a category of drugs for which the licence is requested, unless the licence is to perform tests required under Division 2, distribute as set out in paragraph C.01A.003(a), or wholesale;

• (k) if any of the buildings referred to in paragraph (g) have been inspected under the Act or these Regulations, the date of the last inspection;

• (l) evidence that the applicant’s buildings, equipment and proposed practices and procedures meet the applicable requirements of Divisions 2 to 4;

• (m) in the case of an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building,

  • (i) the name and address of each fabricator, packager/labeller and tester of the drug and the address of each building at which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drug and

    • (A) the dosage form class and whether the drug is in a sterile dosage form, and

    • (B) whether the drug is a bulk process intermediate,

  • (ii) in respect of each activity done in an MRA country at a recognized building, the name of the regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug and that has recognized that building as meeting its good manufacturing practices standards in respect of that activity for that drug, and

  • (iii) in respect of any other activities,

    • (A) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

    • (B) other evidence establishing that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4;

• (n) in the case of any other importer, the name and address of each fabricator, packager/labeller and tester of the drugs proposed to be imported and the address of each building at which the drugs will be fabricated, packaged/labelled and tested, specifying for each building which of those activities and for which category of drugs and, for each category,

  • (i) the dosage form classes and whether any drugs will be in a sterile dosage form, and

  • (ii) whether any drugs will be bulk process intermediates; and

• (o) in the case of an importer referred to in paragraph (n),

  • (i) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

  • (ii) other evidence establishing that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.