190. After Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)) insert—
Regulation 51A
“SCHEDULE 2AInsertion 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 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.”.”.