Food and Drug Regulations

C.01.050 (1) This section applies to a holder of one or more of the following therapeutic product authorizations:

• (a) a drug identification number that has been assigned under subsection C.01.014.2(1); and

• (b) a notice of compliance that has been issued under section C.08.004 or C.08.004.01.

(2) The holder of a therapeutic product authorization in respect of a drug that is part of a class of drugs set out in subsection (4) shall provide the Minister with information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the drug, regarding

• (a) risks that have been communicated by any foreign regulatory authority that is set out in Part A of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a drug within the jurisdiction of such an authority, and the manner of the communication;

• (b) changes that have been made to the labelling of any drug and that have been communicated to or requested by any foreign regulatory authority that is set out in Part B of the list referred to in paragraph (a); and

• (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any drug, that have taken place within the jurisdiction of any foreign regulatory authority that is set out in Part C of the list referred to in paragraph (a).

(3) The information shall be provided to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

(4) The classes of drugs are

• (a) prescription drugs;

• (b) drugs that are required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations; and

• (c) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner.

(5) Despite subsection (2), a holder of a therapeutic product authorization who provided information in accordance with

• (a) paragraph (2)(a) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority or person referred to in that paragraph; or

• (b) paragraph (2)(b) or (c) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority referred to in that paragraph.

(6) In this section, foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements.