# The Human Medicines Regulations 2012, Paragraph 19


The licence holder must—
(a) keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and
(b) permit the person authorised to take copies or make extracts from such documentation.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/4/paragraph/19 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-4/paragraph-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.