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Food and Drug Regulations

Version of section J.01.001 from 2019-12-09 to 2022-01-04:

Marginal note:Definitions

 The following definitions apply in this Part.


Act means the Controlled Drugs and Substances Act. (Loi)

competent authority

competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of restricted drugs into or from the country. (autorité compétente)


compound includes a preparation. (composé)

designated criminal offence

designated criminal offence means

  • (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code;

  • (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code;

  • (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code;

  • (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or

  • (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d). (infraction désignée en matière criminelle)


destroy, in respect of a restricted drug, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction)


hospital means a facility that is

  • (a) licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or

  • (b) owned or operated by the Government of Canada or the government of a province and that provides health services. (hôpital)


institution means any institution engaged in research on drugs and includes a hospital, a university in Canada or a department or agency of the Government of Canada or of a government of a province or any part of them. (établissement)

international obligation

international obligation means an obligation in respect of a restricted drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)


label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette)

licensed dealer

licensed dealer means the holder of a licence issued under section J.01.015. (distributeur autorisé)


package includes anything in which a restricted drug is wholly or partly contained, placed or packed. (emballage)


pharmacist means a person who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)


prescription means an authorization given by a practitioner that a stated amount of a drug be dispensed for the person named in it or the animal identified in it. (ordonnance)

proper name

proper name, in respect of a restricted drug, means the name in English or French that

  • (a) is assigned to the drug in section C.01.002;

  • (b) appears in bold face type for the drug in these Regulations and, if the drug is dispensed in a form other than that described in Part C, the name of the dispensing form; or

  • (c) is assigned in any of the publications mentioned in Schedule B to the Food and Drugs Act in the case of a drug not included in paragraph (a) or (b). (nom propre)

qualified investigator

qualified investigator means, in respect of a restricted drug, a person whose use and possession of that drug are authorized by the Minister under subsection J.01.059(4) and who is

  • (a) employed by or connected with an institution; or

  • (b) engaged in clinical testing or laboratory research in an institution in respect of that drug. (chercheur compétent)

qualified person in charge

qualified person in charge means the individual designated under subsection J.01.012(1). (responsable qualifié)

restricted drug

restricted drug means

  • (a) a controlled substance that is set out in the schedule to this Part; and

  • (b) cocaine (benzoylmethylecgonine) or any of its salts, or a product or compound that contains such a substance, except

    • (i) a drug in dosage form, as defined in subsection C.01.005(3), that has a drug identification number assigned to it under Division 1 of Part C or that is authorized for sale under Division 5 of Part C, and

    • (ii) cocaine (benzoylmethylecgonine) or any of its salts, or a preparation that contains such a substance, that is prepared by a pharmacist in accordance with or in anticipation of a prescription. (drogue d’usage restreint)

Security Directive

Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité)

senior person in charge

senior person in charge means the individual designated under section J.01.011. (responsable principal)

test kit

test kit means a kit

  • (a) that contains a restricted drug and a reagent system or buffering agent;

  • (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a restricted drug for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

  • (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. (nécessaire d’essai)

  • SOR/97-228, s. 22
  • SOR/2004-238, s. 31
  • SOR/2013-172, s. 1
  • SOR/2019-171, s. 22

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