The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024

Insertion of Annex III

10.  After Annex II (correlation table) insert—

Article 19A

“Annex III Transitional provisions in relation to applications and certificates for medicinal products for human use concerning the implementation of the Windsor Framework

New applications

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

(2) For applications lodged in accordance with Article 7(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

(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.

(3) 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.

Certificates in effect in Northern Ireland

2.   Where a certificate granted solely on the basis of a NI authorisation was in effect before 1 January 2025, and a GB authorisation for the same product—

(a) was granted on or after the date on which the certificate took effect but before 1 January 2025,

(b) is in effect on or before 31 December 2024 but a valid notification has not been made to the comptroller in accordance with Article 13A, and

(c) becomes a transitioned-UK authorisation,

the certificate shall continue, on and after 1 January 2025, to have effect solely in the territory of Northern Ireland on the basis of the transitioned-UK authorisation for that product.

Notification of authorisations

3.   For the purposes of Article 13A, the applicant or the certificate holder—

(a) shall notify the comptroller of the grant of a NI authorisation granted before 1 January 2025 in accordance with paragraphs 2 and 3 of Article 13A notwithstanding that it becomes a former NI authorisation on and after 1 January 2025;

(b) shall not be required to notify the comptroller where before the certificate takes effect a GB authorisation becomes a transitioned-UK authorisation.

Lapse or withdrawal of certificates

4.   For the purposes of Article 14—

(a) where a NI authorisation in respect of a product becomes a former NI authorisation and a GB authorisation for the same product becomes a transitioned-UK authorisation, a certificate based upon the NI and GB authorisations before 1 January 2025 shall not lapse;

(b) any reference to the withdrawal of a NI authorisation under Article 14 includes a case where a NI authorisation becomes a former NI authorisation, and in such a case, the authorisation shall be treated as being withdrawn in relation to the territory of Northern Ireland on 1 January 2025.

Paediatric extensions

5.— (1) This paragraph applies to—

(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

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

(i) before 1 January 2025; or

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

(2) Where this paragraph applies, regulation 58A(3) of the Human Medicines Regulations 2012(1) applies without the amendments made by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024.

(3) 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—

(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

(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.”.

(1)

S.I. 2012/1916.