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

SCHEDULE 7 U.K. STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

PART 3 U.K. PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

1.  The holder of the authorisation shall— U.K.

(a) provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the investigational medicinal products [F1 or EAMS medicinal products] which he handles, stores or distributes under his authorisation as are necessary to avoid deterioration of the investigational medicinal products [F1 or EAMS medicinal products];

(b) not use for such purposes premises other than those specified in the authorisation or which may be approved from time to time by the licensing authority; and

(c) ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products [F1 or EAMS medicinal products] are adequate to maintain the quality of those products.

Textual Amendments

F1 Words in Sch. 7 Pt. 3 para. 1 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 18(3)(a) (with reg. 19)