There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005. Any changes that have already been made by the team appear in the content and are referenced with annotations.
5. The manufacturer's licence holder shall—U.K.
(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; and
(b)permit the person authorised to take copies or make extracts from such documentation.
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