Division 1 New applicationsF1

This paragraph applies to applications lodged under Article 7 on or after 1 January 2025.

For applications lodged in accordance with Article 7(1)—

1. (a)

   a NI authorisation under Article 3(b) and Article 3(d) includes a former NI authorisation granted as a NI authorisation during the period commencing on 1 July 2024 and ending on 31 December 2024; and

2. (b)

   any certificate granted under Article 10 in relation to a former NI authorisation of the type referred to in sub-paragraph (a) shall only have effect if a UK authorisation for the same product has been notified to the comptroller in accordance with Article 13A or a copy of such a UK authorisation is contained in the application.

For applications lodged in accordance with Article 7(2), a former NI authorisation that was granted as a NI authorisation for the product specified in the application shall not be considered, for the purpose of Article 3(d), to be the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom.