Paragraph 9
The manufacturer shall keep readily available for inspection by a person authorised by the licensing authority durable records of—
the details of manufacture and assembly of each batch of the medicinal product to which the F1UK marketing authorisation relates; and
the tests carried out on the product,
in such a form that the records will be easily identifiable from the number of the batch as shown on each container in which the medicinal product is exported from the country where it has been manufactured or assembled.
The manufacturer shall permit the person authorised to take copies of or make extracts from such records.
Such records shall not be destroyed for a period of five years from the date of release of the batch concerned, or one year after the expiry date of the batch, whichever is the later.
Annotations
Textual amendments
- F1
Word in Sch. 9 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 52(3); 2020 c. 1, Sch. 5 para. 1(1)
Notes on Schedule 9
Textual amendments
- F1
Words in Sch. 9 heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 52(2); 2020 c. 1, Sch. 5 para. 1(1)