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The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005
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Changes and effects yet to be applied to Schedule 1 Paragraph 5:
- Regulations revoked by S.I. 2012/1916 Sch. 35
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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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