The Human Medicines Regulations 2012 No. 1916

SCHEDULES

[F1 SCHEDULE 8C U.K. Material to accompany an application for a UK marketing authorisation under the unfettered access route

Textual Amendments

F1 Sch. 8C inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 2A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 190)

2.   A copy of all material submitted in support of the application for the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.] U.K.