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Food and Drug Regulations

Version of section C.01A.001 from 2018-10-17 to 2019-12-08:

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

    active ingredient

    active ingredient means a drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect. (ingrédient actif)

    active pharmaceutical ingredient

    active pharmaceutical ingredient means an active ingredient that is used in the fabrication of a pharmaceutical. (ingrédient actif pharmaceutique)

    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)

    bulk process intermediate

    bulk process intermediate means an active ingredient that is used in the fabrication of either a drug of biological origin that is listed in Schedule C to the Act or a drug that is listed in Schedule D to the Act. (produit intermédiaire en vrac)

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


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


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[Repealed, SOR/2002-368, s. 1]


    wholesale[Repealed, SOR/2013-74, s. 2]


    wholesaler means a person who is not a distributor described in section C.01A.003 and who sells any of the following drugs other than at retail sale:

    • (a) a drug in dosage form that is listed in Schedule C or D to the Act, a drug that is a prescription drug or a controlled drug as defined in subsection G.01.001(1);

    • (b) an active ingredient;

    • (c) a narcotic as defined in the Narcotic Control Regulations; or

    • (d) a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act. (grossiste)

  • (2) In this Division and in Division 2, drug does not include any of the following:

    • (a) a dilute drug premix;

    • (b) a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983;

    • (c) an active ingredient that is for veterinary use and that is not an active pharmaceutical ingredient;

    • (d) an active pharmaceutical ingredient for veterinary use that is not required to be sold pursuant to a prescription and that is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations;

    • (e) a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015.

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

  • SOR/97-12, s. 5
  • SOR/98-7, s. 1
  • SOR/2000-120, s. 1
  • SOR/2002-368, s. 1
  • SOR/2004-282, s. 1
  • SOR/2013-74, s. 2
  • SOR/2013-122, s. 14
  • SOR/2017-76, s. 7
  • SOR/2018-144, s. 367

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