The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

This section has no associated Explanatory Memorandum

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.