Food and Drug Regulations

J.01.001 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

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

licence[Repealed, SOR/2004-238, s. 31]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

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

practitioner

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

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 drug set out in the schedule to this Part; (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)