The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 No. 2789

SCHEDULE 1 STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS

2.  The manufacturer’s licence holder may use a contract laboratory pursuant to Article 11(2) of Commission Directive 2003/94/EC if operated by a person approved by the licensing authority.