Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

J.01.013. A dealer’s licence is valid until the earlier of

  • (a) the expiry date set out in the licence, and

  • (b) the revocation or suspension of the licence under section J.01.007.7, J.01.007.8 or J.01.007.9.

  • SOR/2004-238, s. 34.

J.01.014. A permit is valid only for the particular importation or exportation in respect of which it was issued.

Sale of a Restricted Drug

J.01.015. An institution may, in a form approved by the Minister, make an application to a licensed dealer or to the Minister with respect to the purchase of a restricted drug

  • (a) for clinical use in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or

  • (b) for laboratory research in the institution by qualified investigators.

J.01.016. Where a licensed dealer receives an application made pursuant to section J.01.015, he shall, before selling a restricted drug to the institution that made the application

  • (a) supply the Minister with a copy of the application; and

  • (b) obtain the written authority of the Minister to make the proposed sale of the restricted drug.

J.01.017. An application made pursuant to section J.01.015 shall contain

  • (a) the name and the address of the institution seeking to purchase the drug;

  • (b) the names and qualifications of the qualified investigators who will use and be in possession of the drug;

  • (c) the details of the proposed use of the drug;

  • (d) the quantity of the drug required;

  • (e) the dosage form of the drug required by the institution; and

  • (f) the name of the licensed dealer from whom the purchase of the drug will be made.

J.01.018. Where the Minister receives from an institution an application or a copy of an application made pursuant to section J.01.015, he may, subject to such qualifications and limitations as he deems proper, authorize

  • (a) the sale to the institution by a licensed dealer of the restricted drug applied for in such quantity and such dosage form as he deems proper; and

  • (b) qualified investigators to make clinical use of the restricted drug in the institution or to carry out laboratory research with the restricted drug in the institution and to possess the restricted drug for the purposes of such use or research.

J.01.019. An institution shall use a restricted drug only for the purpose and in accordance with the protocol therefor set out in the application respecting that restricted drug made pursuant to section J.01.015.

J.01.020. Where a licensed dealer is authorized under section J.01.018 to sell a restricted drug, he may, notwithstanding section C.08.002, sell that drug subject to any qualifications or limitations imposed by the Minister.