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

Annual Licence Review

• 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.

Refusal to Issue

• 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.

Terms and Conditions

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

  • (a) the requirements 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• (2) [Repealed, SOR/2000-120, s. 4]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 that are imposed under subsection C.01A.008(4) if the Minister believes on reasonable grounds that an amendment is necessary to prevent risk 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 it and its effective date.

• C.01A.012.1 (1) Despite subsection C.01A.008(4), the Minister may, at any time, including when issuing an establishment licence, impose terms and conditions on an establishment licence that is issued or amended under section C.01A.008 on the basis of an application referred to in subsection C.01A.005(2) or C.01A.006(1.1) that contains the statement referred to in the applicable subsection.

• (2) For greater certainty, terms and conditions that may be imposed under subsection (1) are not limited to those that may be imposed under subsection C.01A.008(4).

C.01A.012.2 The Minister may, at any time, amend terms or conditions that are imposed on an establishment licence under subsection C.01A.012.1(1).

Notification

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(1)(a), (b) and (e) to (i); 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.

• C.01A.014 (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless

  • (a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and

  • (b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable.

• (2) Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4:

  • (a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored;

  • (b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug;

  • (c) changes to the practices or procedures; and

  • (d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported.

• C.01A.015 (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer’s establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building.

• (2) The Minister shall, on receiving a notification under subsection (1), amend the importer’s establishment licence by removing the name and address of that fabricator, packager/labeller or tester.

Suspension

• C.01A.016 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if he or she has reasonable grounds to believe that

  • (a) the licensee has contravened any provision of the Act or these Regulations; or

  • (b) the licensee has made a false or misleading statement in the application for the establishment licence.

• (2) Before suspending an establishment licence, the Minister shall consider

  • (a) the licensee’s history of compliance with the Act and these Regulations; and

  • (b) the risk that allowing the licence to continue in force would constitute for the health of the consumer.

• (3) The Minister shall not suspend an establishment licence until

  • (a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

  • (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

  • (c) the licensee has been given an opportunity to be heard in respect of the suspension.

• C.01A.017 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) without giving the licensee an opportunity to be heard if it is necessary to do so to prevent a risk to the health of consumers, by giving the licensee a notice that states the reason for the suspension.

• (2) A licensee may request of the Minister, in writing, that the suspension be reconsidered.

• (3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with the opportunity to be heard.

C.01A.017.1 The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if, after the Minister has, under section 21.31 of the Act, ordered the licensee to conduct an assessment in order to provide evidence establishing that the licensee’s buildings, equipment or practices and procedures, as the case may be, continue to meet the requirements referred to in paragraph C.01A.005(1)(l), subparagraph C.01A.005(1)(m)(ii) or (iii) or paragraph C.01A.005(1)(o),

• (a) the licensee fails to comply with the order; or

• (b) the licensee complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that those requirements continue to be met.

C.01A.018 The Minister shall reinstate an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) that are the subject of the suspension if, within 12 months after the effective date of the suspension, the licensee provides the Minister with sufficient evidence demonstrating that

• (a) the situation on which the suspension was based has been corrected; or

• (b) the situation on which the suspension was based did not exist.

Cancellation

C.01A.018.1 The Minister shall cancel an establishment licence if the licensee has failed to submit an application for the review of the licence in accordance with subsection C.01A.009(1).

• C.01A.018.2 (1) If the Minister has suspended an establishment licence in respect of all matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence.

• (2) If the Minister has suspended an establishment licence in respect of one or more of the matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence only in respect of the matters that are the subject of the suspension.

Designation

• C.01A.019 (1) For the purposes of this Division and Divisions 2 to 4, a regulatory authority that is set out in column 1 of the List of Regulatory Authorities for the Purposes of Section C.01A.019 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time, is designated in respect of the activities set out in column 3 for the drugs or category of drugs set out in column 2.

• (2) Whole blood and its components are excluded from the drugs and categories of drugs that are set out in column 2 of the List.

• (3) The lot release of drugs listed in Schedule D to the Act is excluded from the activity of testing set out in column 3 of the List.

DIVISION 2Good Manufacturing Practices

C.02.001 [Repealed, SOR/97-12, s. 5.1]

C.02.002 In this Division,

drug

drug[Repealed, SOR/97-12, s. 6]

importer

importer[Repealed, SOR/97-12, s. 6]

medical gas

medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)

packaging material

packaging material includes a label; (matériel d’emballage)

produce

produce[Repealed, SOR/97-12, s. 6]

quality control department

quality control department[Repealed, SOR/2010-95, s. 1]

specifications

specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

• (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,

• (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and

• (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)

C.02.002.1 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.

C.02.002.2 In this Division,

• (a) a reference to specifications is — in respect of a drug intended for consumption or use outside Canada, the raw material used in such a drug or the packaging material for such a drug — a reference to the specifications with which the drug, raw material or packaging material is required to comply in the country in which the drug is intended to be consumed or used; and

• (b) the definition expiration date in subsection C.01.001(1) does not apply in respect of a drug intended for consumption or use outside Canada.