Food and Drug Regulations (C.R.C., c. 870)

Application

• C.01A.002 (1) This Division does not apply to

  • (a) wholesaling a drug premix;

  • (b) subject to subsection (3), importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons:

    • (i) a pharmacist,

    • (ii) a practitioner, and

    • (iii) a person who compounds a drug under the supervision of a practitioner;

  • (b.1) any activity with respect to a positron-emitting radiopharmaceutical that is used only for the purposes of a basic clinical research study described in section C.03.304;

  • (c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.005,

  • (d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributer referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A to the Act, namely,

    • (i) homeopathic drugs,

    • (ii) drugs that meet the requirements of a class monograph entitled “Vitamin Supplements”, “Mineral Supplements”, “Dietary Vitamin Supplements” or “Dietary Mineral Supplements”, as the case may be, and

    • (iii) drugs that

      • (A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and

      • (B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and

  • (e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.

• (1.1) This Division and Division 2 do not apply to a veterinary health product or an active pharmaceutical ingredient that is used in the fabrication of a veterinary health product.

• (2) This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.

• (3) This Division applies to the importing, by a pharmacist, a veterinary practitioner or a person who compounds a drug under the supervision of a veterinary practitioner, of an active pharmaceutical ingredient for veterinary use that is for the purpose of compounding, pursuant to a prescription, a drug in dosage form that is not commercially available in Canada, if that ingredient is set out in List A.

C.01A.003 This Division and Divisions 2 to 4 apply to the following distributors:

• (a) a distributor of an active ingredient; and

• (b) a distributor of a drug for which the distributor holds the drug identification number.

Prohibition

• C.01A.004 (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,

  • (a) fabricate, package/label or import a drug;

  • (b) perform the tests, including examinations, required under Division 2;

  • (c) distribute as a distributor referred to in section C.01A.003 a drug that is not an active pharmaceutical ingredient or 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; or

  • (d) wholesale a drug that is not an active pharmaceutical ingredient or 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.

• (2) A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.

• (3) No person shall carry on an activity referred to in subsection (1) unless the person holds

  • (a) in respect of a narcotic as defined in the Narcotic Control Regulations, a licence for that narcotic under those Regulations;

  • (b) in respect of a controlled drug as defined in subsection G.01.001(1), a licence for that drug under Part G; or

  • (c) in respect of a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act, a licence for that drug to conduct that activity under the Cannabis Regulations.

Application

C.01A.005 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 and documents:

• (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 an active ingredient;

• (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 the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form;

• (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, each controlled drug as defined in subsection G.01.001(1) or each drug containing cannabis as defined in subsection 2(1) of the Cannabis Act 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 in which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form,

  • (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 in which the drugs will be fabricated, packaged/labelled and tested, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form; 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.