6. Where the holder of the authorisation has been informed by the licensing authority that any batch of any investigational medicinal product [F1or 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, [F2the 2012 Regulations] or any regulations under the Act that are applicable to the investigational medicinal product[F1or EAMS medicinal product],
he shall, if so directed, withhold such batch from distribution for use in clinical trials [F3or 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
F1Words in Sch. 7 Pt. 3 para. 6 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)(c)(i) (with reg. 19)
F2Words in Sch. 7 Pt. 3 para. 6 substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 62(b)(i) (with Sch. 32)
F3Words in Sch. 7 Pt. 3 para. 6 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)(c)(ii) (with reg. 19)