Food and Drug Regulations — C.01A.001
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 ) 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 ) MRA country means a country that is a participant in a mutual recognition agreement with Canada. ( pays participant ) 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 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 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 ) 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 ( autorité réglementaire ) site [Repealed, SOR/2002-368, s. 1] wholesale [Repealed, SOR/2013-74, s. 2] wholesaler means a person who is not a distributor described in section C.01A.003 and who sells any of the following drugs other than at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 section G.01.001; (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 1(1) of the Feeds Regulations, 2024 ; (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 SOR/2019-171, s. 24 SOR/2020-73, s. 1 SOR/2024-132, s. 86 SOR/2024-132, s. 87