Division 5 Paediatric extensionsF1

This paragraph applies to—

1. (a)

   an application for an extension of the duration of a certificate, lodged in accordance with Article 7(3) or (4) but not determined before 1 January 2025; and

2. (b)

   an extension of the duration of a certificate granted in accordance with Article 10—

   1. (i)

      before 1 January 2025; or

   2. (ii)

      on or after 1 January 2025, pursuant to an application falling within sub-paragraph (a).

Where this paragraph applies, regulation 58A(3) of the Human Medicines Regulations 2012 applies without the amendments made by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024.

This paragraph applies only to an application for an extension of the duration of a certificate which has not been determined before 1 January 2025 where—

1. (a)

   the condition set out in sub-paragraph (a) or (b) in regulation 58A(3) of the Human Medicines Regulations 2012 was met before 1 January 2025; or

2. (b)

   the period for lodging an application for an extension of the duration of a certificate in Article 7(4) expires before 1 January 2025.