Food and Drug Regulations — C.01.001
C.01.001 (1) In this Part acetaminophen product has the same meaning as in Division 9; ( produit d’acétaminophène ) adult standard dosage unit has, with reference to a drug, the same meaning as in Division 9; ( dose normale pour adultes ) adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; ( réaction indésirable à une drogue ) antibiotic means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; ( antibiotique ) authorization holder [Repealed, SOR/2017-259, s. 1] brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French, (a) that is assigned to the drug by its manufacturer, (b) under which the drug is sold or advertised, and (c) that is used to distinguish the drug; ( marque nominative ) case report means a detailed record of all relevant data associated with the use of a drug in a subject; ( fiche d’observation ) children’s standard dosage unit has, with reference to a drug, the same meaning as in Division 9; ( dose normale pour enfants ) child resistant package means a package that meets the requirements of subsection (2); ( emballage protège-enfants ) common name means, with reference to a drug, the name in English or French by which the drug is (a) commonly known, and (b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; ( nom usuel ) COVID-19 means the coronavirus disease 2019; ( COVID-19 ) COVID-19 drug means a drug, other than a veterinary health product, that is manufactured, sold or represented for use in relation to COVID-19; ( drogue contre la COVID-19 ) discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug; ( cesser ) expiration date means (a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month: (i) the date up to and including which the drug maintains its labelled potency, purity and physical characteristics, and (ii) the date after which the manufacturer recommends that the drug not be used; and (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month: (i) the retest date, or (ii) the date after which the manufacturer recommends that the active ingredient not be used; ( date limite d’utilisation ) flavour means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug solely to produce or mask a particular taste. It does not include an ingredient or combination of ingredients that impart only a sweet taste to the drug; ( saveur ) fragrance means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug to produce or mask a particular odour; ( parfum ) immediate container means the receptacle that is in direct contact with a drug; ( récipient immédiat ) internal use means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; ( usage interne ) ISAD Interim Order means the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 made by the Minister on September 16, 2020 and published in Part I of the Canada Gazette on October 3, 2020; ( arrêté d’urgence IVPD ) List A means the document, entitled List of Certain Antimicrobial Active Pharmaceutical I