10. The holder of the authorisation shall ensure that any tests for determining conformity with the standards and specifications applying to any particular product used in the manufacture shall, except so far as the conditions of the product specification for that product otherwise provide, be applied to samples taken from the investigational medicinal product [F1or EAMS medicinal product] after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the licensing authority.U.K.
Textual Amendments
F1Words in Sch. 7 Pt. 2 para. 10 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)(d) (with reg. 19)