Paragraph 190 I1

After Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)) insert—

“SCHEDULE 2A

Insertion of new Schedule 8C (Material to accompany an application for a UK marketing authorisation under the unfettered access route)

Regulation 51A

1

After Schedule 8B to the Human Medicines Regulations 2012, insert—

“SCHEDULE 8C

Material to accompany an application for a UK marketing authorisation under the unfettered access route

Regulation 50(1)

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.”.”.