Food and Drug Regulations — C.01A.001
C.01A.001 (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4. 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 means an active ingredient that is used in the fabrication of a pharmaceutical. ( ingrédient actif pharmaceutique ) 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 means a certificate issued by the fabricator of a lot or batch of a drug that is either imported within the framework of a mutual recognition agreement or referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, 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 (i) in the case of a drug that is imported within the framework of a mutual recognition agreement, in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards, or (ii) in the case of a drug that is not imported within the framework of a mutual recognition agreement and that is referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, in accordance with the requirements of Division 2. ( certificat de lot ) 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 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 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 subsection 1(1) of the Feeds Regulations, 2024 , with the lowest approved dosage level of the drug. ( prémélange médicamenteux dilué ) 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 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 d