Paragraph 190

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.”.”.