SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 19Insertion of Schedule 2A (insertion of new Schedule 8C (material to accompany an application for a UK marketing authorisation under the unfettered access route))
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After Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)) insert—
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—
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.