The Human Medicines Regulations 2012 No. 1916

SCHEDULES

Regulation 50(1)

[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)

1.   A copy of the application submitted in connection with the granting of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland. U.K.

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.

3.   A copy of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.] U.K.