- active ingredient
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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)
- antimicrobial agent
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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
- batch certificate
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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
- dilute drug premix
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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)
- drug premix
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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)
- List of Non-prescription Drugs Not Subject to Certain Testing Requirements
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List of Non-prescription Drugs Not Subject to Certain Testing Requirements means the document entitled List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019(1) and (2) of the Food and Drug Regulations Do Not Apply that is published by the Government of Canada on its website, as amended from time to time. (Liste de drogues vendues sans ordonnance et non soumises à certaines analyses)
- recognized building
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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)
- recognized country or region
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recognized country or region means a country or region that is set out in the document entitled List of Foreign Countries or Regions and Their Regulatory Authorities for the Application of Subsection C.02.019(5) of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time. (pays ou régions reconnus)
- wholesaler
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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:
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(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 section G.01.001;
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[...]
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(c) a narcotic as defined in the Narcotic Control Regulations; or
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(d) a drug containing cannabisas defined in subsection 2(1) of the Cannabis Act. (grossiste)
