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

Regulations are current to 2019-11-19 and last amended on 2019-06-17. Previous Versions

PART JRestricted Drugs (continued)

DIVISION 1 (continued)

Licences, Permits and Licensed Dealers (continued)

  •  (1) The Minister shall suspend a permit without prior notice if

    • (a) the dealer’s licence as it pertains to the restricted drug to be imported or exported has expired or has been suspended or revoked;

    • (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety, or security;

    • (c) the Minister has reasonable grounds to believe that the continuation of the permit would present a risk of a restricted drug being diverted to an illicit market or use; or

    • (d) the import or export would contravene the laws of the country of export or import or a country of transit or transhipment.

  • (2) A decision of the Minister to suspend a permit takes effect as soon as the Minister notifies the holder of the decision and provides a written report of the reasons for the suspension.

  • (3) A person whose permit is suspended under subsection (1) may, within 10 days after receiving the notice of suspension, provide the Minister with reasons why the suspension is unfounded.

  • SOR/2010-222, s. 30

 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

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

Sale of a Restricted Drug

 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.

 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.

 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.

 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.

 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.

 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.

Records and Inspection

 Every institution shall keep and retain for a period of two years from the date of the making of the record, a record of

  • (a) the amount of every restricted drug received by the institution;

  • (b) details of the use of restricted drugs in the institution;

  • (c) the names and qualifications of every person who makes use of a restricted drug in the institution; and

  • (d) full clinical data with respect to the use of every restricted drug received by the institution.

  • SOR/85-550, s. 15

 Every institution shall make its records referred to in section J.01.021 available to the Minister upon his request and shall permit such inspection of the institution, respecting its use of restricted drugs, as the Minister may require.

 Every licensed dealer shall maintain a record of

  • (a) the name, quantity and form of any restricted drug received by them, the name and address of the person who sold or provided it and the date it was received;

  • (b) the name, quantity and form of any restricted drug sold or provided by them, the name and address of the person to whom it was sold or provided and the date it was sold or provided;

  • (c) the name, quantity and form of any restricted drug they have used in making or assembling a product or compound containing that restricted drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

  • (d) the name and quantity of any restricted drug produced and the date on which it was placed in stock; and

  • (e) the name, quantity and form of any restricted drug he has in stock.

  • SOR/2004-238, s. 35
  • SOR/2010-222, s. 31(F)

 Every licensed dealer and every person who has been a licensed dealer shall keep the record referred to in section J.01.023 on the premises described in the licence that was issued to him or in such other place as may be approved by the Minister for a period of at least two years and shall keep such record in a form that will facilitate an audit thereof being made at any time.

  •  (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of

    • (a) the premises used or intended to be used in producing, making, assembling or storing a restricted drug; and

    • (b) the process and conditions of the producing, making, assembling or storing.

  • (2) [Repealed, SOR/2010-222, s. 32]

  • SOR/2004-238, s. 36
  • SOR/2010-222, s. 32

 Every person who sells or provides a restricted drug shall

  • (a) supply such information in such form as the Minister may require respecting the dealings of any person in the restricted drug;

  • (b) produce to an inspector any books, records or documents required to be kept under this Part;

  • (c) permit an inspector to make copies of or to take extracts from any books, records and documents; and

  • (d) permit an inspector to check all stocks of restricted drugs located on the premises described in his licence.

  • SOR/2004-238, s. 37

 Every licensed dealer shall notify the Minister forthwith of any change

  • (a) [Repealed, SOR/2010-222, s. 33]

  • (b) in the premises in which a restricted drug is produced, made, assembled or stored; and

  • (c) in the process and conditions of producing, making, assembly or storage of a restricted drug.

  • SOR/2004-238, s. 38
  • SOR/2010-222, s. 33

 Every licensed dealer who possesses a restricted drug, every qualified investigator who possesses a restricted drug for the purpose of and in connection with research in an institution, every person exempted under section 56 of the Act with respect to a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister must

  • (a) provide such protection against loss or theft of the restricted drug as may be required by the Minister; and

  • (b) report forthwith to the Minister and to local law enforcement authorities any loss or theft of a restricted drug.

  • SOR/2015-210, s. 3
  • SOR/2018-85, s. 2
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