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

C.01.612. [Repealed, SOR/94-568, s. 3]

C.01.625. Contraceptive drugs that are manufactured, sold or represented for use in the prevention of conception and that are not listed in Schedule F may be advertised to the general public.

• C.01A.001. (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4.

  “antimicrobial agent”

  “antimicrobial agent” means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that

  • (a) are not invasive devices as defined in those Regulations; and

  • (b) are intended to come into contact with intact skin only. (agent antimicrobien)

  “batch certificate”

  “batch certificate” means a certificate issued by the fabricator of a lot or batch of a drug that is exported within the framework of a mutual recognition agreement and in which the fabricator

  • (a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document;

  • (b) provides a detailed description of the drug, including

    • (i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and

    • (ii) a statement of tolerances for the properties and qualities of the drug;

  • (c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained;

  • (d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and

  • (e) certifies that the lot or batch was fabricated, packaged/labelled and tested in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards. (certificat de lot)

  “class monograph”

  “class monograph” means a document prepared by the Department of Health that

  • (a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and

  • (b) sets out labelling and other requirements that apply to those drugs. (monographie de classe)

  “dilute drug premix”

  “dilute drug premix” means a drug for veterinary use that results from mixing a drug premix with a feed as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. (prémélange médicamenteux dilué)

  “dosage form class”

  “dosage form class” means a parenteral, tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. (classe de forme posologique)

  “drug premix”

  “drug premix” means a drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (prémélange médicamenteux)

  “fabricate”

  “fabricate” means to prepare and preserve a drug for the purposes of sale. (manufacturer)

  “import”

  “import” means to import into Canada a drug for the purpose of sale. (importer)

  “MRA country”

  “MRA country” means a country that is a participant in a mutual recognition agreement with Canada. (pays participant)

  “mutual recognition agreement”

  “mutual recognition agreement” means an international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (accord de reconnaisance mutuelle)

  “package/label”

  “package/label” means to put a drug in its immediate container or to affix the inner or outer label to the drug. (emballer-étiqueter)

  “pharmaceutical”

  “pharmaceutical” means a drug other than a drug listed in Schedule C or D to the Act. (produit pharmaceutique)

  “recognized building”

  “recognized building” means, in respect of the fabrication, packaging/labelling or testing of a drug, a building that a regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug has recognized as meeting its good manufacturing practices standards in respect of that activity for that drug. (bâtiment reconnu)

  “regulatory authority”

  “regulatory authority” means a government agency or other entity in an MRA country that has a legal right to control the use or sale of drugs within that country and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements. (autorité réglementaire)

  “site”

  “site”[Repealed, SOR/2002-368, s. 1]

  “wholesale”

  “wholesale” means to sell any of the following drugs, other than at retail sale, where the seller’s name does not appear on the label of the drugs:

  • (a) a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations or a controlled drug as defined in subsection G.01.001(1); or

  • (b) a narcotic as defined in the Narcotic Control Regulations. (vendre en gros)

• (2) In this Division and in Division 2, “drug” means a drug in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act or in Schedule D to the Act that is of biological origin. It does not include a dilute drug premix, a medicated feed as defined section 2 of the Feeds Regulations, 1983, a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015 or a drug listed in Schedule H to the Act.

• (3) Where the Minister designates additional dosage form classes, the Minister shall make a list of those classes available on request.