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

12.  Where—

(a)animals are used in the production of any medicinal products; and

(b)relevant marketing authorizations contain provisions relating to them,

the manufacturer’s licence holder shall arrange for those animals to be housed in premises of such a nature, and be managed in such a manner as to facilitate compliance with such provisions.