Food and Drug Regulations

C.01A.001 (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4.

active ingredient

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)

active pharmaceutical ingredient

active pharmaceutical ingredient means an active ingredient that is used in the fabrication of a pharmaceutical. (ingrédient actif pharmaceutique)

antimicrobial agent

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

• (a) are not invasive devices as defined in those Regulations; and

• (b) are intended to come into contact with intact skin only. (agent antimicrobien)

batch certificate

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

• (a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document;

• (b) provides a detailed description of the drug, including

  • (i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and

  • (ii) a statement of tolerances for the properties and qualities of the drug;

• (c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained;

• (d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and

• (e) certifies that the lot or batch was fabricated, packaged/labelled and tested

  • (i) in the case of a drug that is imported within the framework of a mutual recognition agreement, in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards, or

  • (ii) in the case of a drug that is not imported within the framework of a mutual recognition agreement and that is referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, in accordance with the requirements of Division 2. (certificat de lot)

bulk process intermediate

bulk process intermediate means an active ingredient that is used in the fabrication of either a drug of biological origin that is listed in Schedule C to the Act or a drug that is listed in Schedule D to the Act. (produit intermédiaire en vrac)

class monograph

class monograph means a document prepared by the Department of Health that

• (a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and

• (b) sets out labelling and other requirements that apply to those drugs. (monographie de classe)

dilute drug premix

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)

dosage form class

dosage form class means a parenteral, tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. (classe de forme posologique)

drug premix

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)

fabricate

fabricate means to prepare and preserve a drug for the purposes of sale. (manufacturer)

import

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

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

MRA country means a country that is a participant in a mutual recognition agreement with Canada. (pays participant)

mutual recognition agreement

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

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

pharmaceutical means a drug other than a drug listed in Schedule C or D to the Act. (produit pharmaceutique)

recognized building

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

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

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

site[Repealed, SOR/2002-368, s. 1]

wholesale

wholesale[Repealed, SOR/2013-74, s. 2]

wholesaler

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.