# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 7


The holder of the authorisation shall—
(a) keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of Commission Directive 2003/94/EC in respect of Great Britain or Article 8 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland; 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/2004/1031/schedule/7/part/2/paragraph/7 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-7/part-2/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.