# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 190

Extent: E+W+S+N.I.

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.”.”.

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Source: https://www.legislation.gov.uk/uksi/2020/1488/schedule/2/paragraph/190 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-190
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.