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

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/190 (the official version)
Page: https://openlegislation.uk/draft-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.