Regulation (EC) No 469/2009 of the European Parliament and of the CouncilShow full title

[F1 Article 13A U.K. Authorisation granted after submission of an application for a certificate

1. Where after the date of submission of an application under Article 7(1) or (2), but before the grant of a certificate under Article 10(1) in relation to a NI authorisation, a valid UK or GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom or the territory of England and Wales and Scotland as the case may be, the applicant shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

2. Where after the submission of an application under Article 7(1) or (2), but before the grant of a certificate under Article 10(1) in relation to a UK or GB authorisation, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of Northern Ireland, the applicant shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

3. Where after the grant of a certificate under Article 10(1) in relation to a UK or GB authorisation, but before expiry of the basic patent, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of Northern Ireland, the certificate holder shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

4. Where after the grant of a certificate under Article 10(1) in relation to a NI authorisation, but before expiry of the basic patent, a valid UK or GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom or the territory of England and Wales and Scotland as the case may be, the certificate holder shall notify the comptroller of the grant of the F2 ... authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

5. If the applicant or the certificate holder fails to notify the comptroller of the grant of an authorisation in accordance with paragraph 1, 2, 3 or 4 the protection conferred by a certificate granted under Article 10 shall not extend to any additional territory covered by that authorisation.

6. On receipt of a notification under any of paragraphs 1 to 4, the comptroller shall publish:

(a) the number and date of the authorisation,

(b) the product identified in that authorisation, and

(c) the territory in respect of which the authorisation has been granted or has effect as if granted.]

Textual Amendments

F1 Arts. 13A, 13B inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 19 (with reg. 7)

F2 Word in Art. 13A(4) omitted (1.1.2025) by virtue of The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 7