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

• C.01A.009. (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referrred to in section C.01A.005.

• (2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.

• C.01A.010. (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if

  • (a) the applicant has made a false or misleading statement in relation to the application for the licence; or

  • (b) the applicant has had an establishment licence suspended in respect of the matter.

• (2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.

• (3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall

  • (a) notify the applicant in writing of the reasons for the refusal; and

  • (b) give the applicant an opportunity to be heard.

• C.01A.011. (1) Every person who holds an establishment licence shall comply with

  • (a) the requirements and the terms and conditions of the establishment licence; and

  • (b) the applicable requirements of Divisions 2 to 4.

• (2) [Repealed, SOR/2000-120, s. 4]

• C.01A.012. (1) The Minister may amend the terms and conditions of an establishment licence if the Minister believes on reasonable grounds that an amendment is necessary to prevent injury to the health of the consumer.

• (2) The Minister shall give at least 15 days notice in writing to the holder of the establishment licence of the proposed amendment, the reasons for the amendment and its effective date.

C.01A.013. Every person who holds an establishment licence shall notify the Minister in writing within 15 days after

• (a) there is any change to the information referred to in any of paragraphs C.01A.005(a),(b),(e),(f),(h) and (i), and subparagraphs C.01A.005(g)(i) and (ii); or

• (b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.