Point in time view as at 01/01/2022.
The Human Medicines Regulations 2012, Paragraph 9 is up to date with all changes known to be in force on or before 06 May 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
9.—(1) The manufacturer shall keep readily available for inspection by a person authorised by the licensing authority durable records of—U.K.
(a)the details of manufacture and assembly of each batch of the medicinal product to which the [F1UK] marketing authorisation relates; and
(b)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.
(2) The manufacturer shall permit the person authorised to take copies of or make extracts from such records.
(3) 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.
Textual Amendments
F1Word 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)
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