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

9.  Where the holder of the authorisation has been informed by the licensing authority that any batch of any investigational medicinal product [F1 or EAMS medicinal product] to which his authorisation relates has been found not to conform as regards strength, quality or purity with— U.K.

(a) the specification of the relevant product; or

(b) the provisions of these Regulations, [F2 or the 2012 Regulations] that are applicable to the investigational medicinal product [F1 or EAMS medicinal product],

he shall, if so directed, withhold such batch from distribution for use in clinical trials [F3 or as part of the Early Access to Medicines Scheme], so far as may be reasonably practicable, for such a period not exceeding six weeks as may be specified by the licensing authority.

Textual Amendments

F1 Words in Sch. 7 Pt. 2 para. 9 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)(c)(i) (with reg. 19)

F2 Words in Sch. 7 Pt. 2 para. 9 substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 62(a)(ii) (with Sch. 32)

F3 Words in Sch. 7 Pt. 2 para. 9 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)(c)(ii) (with reg. 19)