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Food and Drug Regulations

Version of section C.01.020.1 from 2019-12-16 to 2022-03-01:

  •  (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.

  • SOR/2019-190, s. 2
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