Food and Drug Regulations

C.02.023 (1) On receipt of a complaint or any information respecting the quality of a drug or its deficiencies or hazards, every fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 and importer of the drug shall make a record of the complaint or information that contains the following:

• (a) the results of any investigation carried out under subsection C.02.015(2) and, if applicable, the corrective action taken; or

• (b) the name and business address of the person in charge of the quality control department to whom the complaint or information was forwarded under subsection C.02.015(2.1) and the date on which it was forwarded.

(2) Records referred to in subsection (1) shall be retained for the following period unless the person holds an establishment licence that specifies some other period:

• (a) in the case of a drug in dosage form, one year after the expiration date of the lot or batch of the drug; and

• (b) in the case of an active ingredient,

  • (i) if the active ingredient has a retest date, three years after the lot or batch has been completely distributed, or

  • (ii) in any other case, one year after the expiration date of the lot or batch of the active ingredient.