Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance)
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There are currently no known outstanding effects by UK legislation for Regulation (EC) No 469/2009 of the European Parliament and of the Council, Article 7.
1.The application for a certificate shall be lodged within six months of the date on which the [F1UK, GB or NI] authorisation referred to in Article 3(b) [F2and (d)] to place the product on the market as a medicinal product was granted.
[F3Where more than one such authorisation is granted before the application for a certificate is lodged, the application shall be lodged within six months of the date of grant of the earliest of such authorisations.]
2.Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.
[F42a.Where an application for a certificate lodged before 1 January 2025 in accordance with paragraph 1 or 2 contains a NI authorisation granted pursuant to Regulation (EU) 2019/6, that authorisation shall be treated on and after 1 January 2025 as if it were a valid NI authorisation for the purpose of Article 3(b) and (d) at the time the application was lodged.]
3.The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled.
4.The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.
5.Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.
Textual Amendments
F1Words in Art. 7(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 14(a) (with reg. 7)
F2Words in Art. 7(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 14(b) (with reg. 7)
F3Words in Art. 7(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 14(c) (with reg. 7)
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