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designated COVID-19 drug[Repealed, SOR/2024-238, s. 24]

List of Conditions that Threaten Public Health

List of Conditions that Threaten Public Health means the List of Conditions that Threaten Public Health in Canada, published on the Government of Canada’s website, as amended from time to time; (Liste d’affections qui menacent la santé publique)

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)

public health emergency drug

public health emergency drug means a new drug for which the purpose and conditions of use recommended by the manufacturer relate to a condition that is described in the List of Conditions that Threaten Public Health; (drogue pour urgence de santé publique)

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)