PART 19 U.K.Insertion of Schedule 2A (insertion of new Schedule 8C (material to accompany an application for a UK marketing authorisation under the unfettered access route))
190. After Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)) insert—U.K.
Regulation 51A
“SCHEDULE 2AU.K.Insertion of new Schedule 8C (Material to accompany an application for a UK marketing authorisation under the unfettered access route)
1. After Schedule 8B to the Human Medicines Regulations 2012, insert—
Regulation 50(1)
“SCHEDULE 8CU.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
I1Sch. 2 para. 190 in force at 31.12.2020 immediately before IP completion day, see reg. 1