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.
- SOR/97-12, s. 5;
- SOR/2000-120, s. 5;
- SOR/2002-368, s. 6.
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.
- SOR/97-12, s. 5;
- SOR/2000-120, s. 6;
- SOR/2002-368, s. 7.
C.01A.016. (1) Subject to subsection (3), the Minister may suspend 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
(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) Subject to subsection C.01A.017(1), the Minister shall not suspend an establishment licence until
(a) an inspector 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.
- SOR/97-12, s. 5.
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