Food and Drug Regulations

C.01.020.1 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a serious adverse drug reaction.

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

• (a) the name of the hospital and the contact information of a representative of that hospital;

• (b) the drug’s brand name, proper name or common name;

• (c) in the case of a drug imported under subsection C.10.001(2), the identifying code or number of the drug, if any, assigned in the country in which the drug was authorized for sale;

• (d) the drug identification number assigned for the drug, if applicable;

• (e) the patient’s age and sex;

• (f) a description of the serious adverse drug reaction;

• (g) the date on which the serious adverse drug reaction was first documented;

• (h) the date on which the patient first used the drug and, if applicable, the date on which the patient stopped using the drug;

• (i) the date on which the serious adverse drug reaction first occurred and, if applicable, the date on which the patient’s health was restored to its state prior to the reaction;

• (j) any medical condition of the patient that directly relates to the serious adverse drug reaction;

• (k) any concomitant therapeutic products used by the patient; and

• (l) the effect of the serious adverse drug reaction on the patient’s health.

(3) A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if

• (a) the hospital does not have in its control all of the information referred to in paragraphs (2)(b), (c), (e) and (f) in respect of the serious adverse drug reaction; or

• (b) the serious adverse drug reaction relates only to any of the following drugs:

  • (i) a vaccine that was administered under a routine immunization program of a province,

  • (ii) a drug that is authorized for sale under Division 5 of this Part, or

  • (iii) a drug that was sold under subsection C.08.011(1).

(4) In this section, hospital means a facility

• (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or

• (b) that is operated by the Government of Canada and that provides health services to in-patients.