F1SCHEDULE 2AInsertion of new Schedule 8C (Material to accompany an application for a UK marketing authorisation under the unfettered access route)
Annotations:
Amendments (Textual)
I11
After Schedule 8B to the Human Medicines Regulations 2012, insert—
SCHEDULE 8CMaterial 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.
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