Regulation 51A

[F1 SCHEDULE 2A U.K.Insertion of new Schedule 8C (Material to accompany an application for a UK marketing authorisation under the unfettered access route)

Textual Amendments

F1 Sch. 2A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 190

1.   After Schedule 8B to the Human Medicines Regulations 2012, insert— U.K.

Regulation 50(1)

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

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.

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.

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

Commencement Information

I1 Sch. 2A para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1