Food and Drug Regulations

C.10.004 (1) For the purposes of section 21.8 of the Act, the prescribed health care institutions that must provide information to the Minister about a serious adverse drug reaction that involves a drug imported under subsection C.10.001(2) are the health care institutions authorized by the laws of a province to provide acute care services.

(2) The following prescribed information about a serious adverse drug reaction must be provided to the Minister in writing within 30 days after the day on which the reaction is first documented:

• (a) the name of the health care institution and the contact information of a representative of that institution;

• (b) the name and identifying number or code of the drug that is suspected of causing the reaction; and

• (c) a description of the serious adverse drug reaction.