Food and Drug Regulations

C.02.021 (1) All records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage, including storage during transportation, of a drug in dosage form that are required to be maintained under this Division shall be retained for one year after the expiration date of the drug unless the relevant establishment licence specifies some other period.

(2) Subject to subsection (4), all records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage, including during transportation, of an active ingredient that are required to be maintained under this Division shall be retained in respect of each lot or batch of the active ingredient for the following period unless the relevant establishment licence specifies some other period:

• (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or

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

(3) Subject to subsection (4), all records and evidence of the raw material testing referred to in section C.02.009 and of the testing of packaging/labelling materials that are required to be maintained under this Division shall be retained for five years after the raw materials and packaging/labelling materials were last used in the fabrication or packaging/labelling of a drug unless the relevant establishment licence specifies some other period.

(4) If a fabricator is required to maintain records and evidence in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable.