SCHEDULE 7 U.K. STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

PART 2 U.K. PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS

4.  The holder of the authorisation 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. U.K.