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1. The holder of the authorisation shall—U.K.
(a)provide and maintain such staff, premises and plant (including technical equipment) as are necessary for the carrying out, in accordance with his authorisation and the product specification, of such stages of the manufacture and assembly of the investigational medicinal products [F1or EAMS medicinal products] as are undertaken by him; and
(b)not carry out any such manufacture or assembly except at the premises specified in his manufacturing authorisation.
Textual Amendments
F1Words in Sch. 7 Pt. 2 para. 1(a) 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(2)(a) (with reg. 19)