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 [F1or EAMS medicinal products] which he handles, stores or distributes under his authorisation as are necessary to avoid deterioration of the investigational medicinal products [F1or 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 [F1or EAMS medicinal products] are adequate to maintain the quality of those products.
Textual Amendments
F1Words 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)