Food and Drug Regulations

C.08.001.1 For the purposes of this Division,

Canadian reference product

Canadian reference product means

• (a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug,

• (b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or

• (c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); (produit de référence canadien)

designated COVID-19 drug

designated COVID-19 drug means a new drug for which the purpose and conditions of use recommended by the manufacturer relate to COVID-19; (drogue désignée contre la COVID-19)

pharmaceutical equivalent

pharmaceutical equivalent means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; (équivalent pharmaceutique)

specifications

specifications means a detailed description of a new drug and of its ingredients and includes

• (a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients,

• (b) a detailed description of the methods used for testing and examining the ingredients, and

• (c) a statement of the tolerances associated with the properties and qualities of the ingredients. (spécifications)