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Food and Drug Regulations

Version of section J.01.001 from 2013-10-02 to 2019-12-08:

 In this Part,

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)


institution means any institution engaged in research on drugs and includes a hospital that is licensed by a province, a university, a department or agency of the Government of Canada or of a province or any part thereof; (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)


licence[Repealed, SOR/2004-238, s. 31]

licensed dealer

licensed dealer means the holder of a licence issued under section J.01.007.2; (distributeur autorisé)


permit means a permit issued under section J.01.005; (permis)


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


practitioner means a person who is registered and entitled under the laws of a province to practise the profession of medicine; (praticien)


prescription means an authorization given by a practitioner, as defined in subsection 2(1) of the Act, that a stated amount of a drug be dispensed for the person named in the authorization; (ordonnance)

qualified investigator

qualified investigator means, in respect to a restricted drug, a person who

  • (a) is employed by or is connected with an institution, or

  • (b) is engaged in research in an institution in respect of that drug,

and whose use and possession of that drug is authorized by the Minister pursuant to section J.01.018; (chercheur compétent)

qualified person in charge

qualified person in charge means the individual with the qualifications specified in subsection J.01.003.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable)

restricted drug

restricted drug means

  • (a) any substance that is set out in the schedule to this Part or anything that contains the substance; and

  • (b) cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, except 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 except cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, that is to be or that has been compounded by a pharmacist in accordance with or in anticipation of a prescription; (drogue d’usage restreint)

test kit

test kit means an apparatus

  • (a) that contains reagent systems or buffering agents or both,

  • (b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and

  • (c) the contents of which are not intended for administration to humans. (nécessaire d’essai)

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

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