Food and Drug Regulations

Marginal note:Approval

• J.01.027 (1) Subject to section J.01.028, on completion of the review of the application for approval of the change, the Minister must approve the change.

• Marginal note:Terms and conditions

  (2) When approving a change, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete one in order to

  • (a) ensure that an international obligation is respected;

  • (b) ensure conformity with the requirements associated with the security level specified in the licence; or

  • (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.