The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

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

10.  The holder of the authorisation shall ensure that any tests for determining conformity with the standards and specifications applying to any particular product used in the manufacture shall, except so far as the conditions of the product specification for that product otherwise provide, be applied to samples taken from the investigational medicinal product after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the licensing authority. U.K.