Regulation (EC) No 469/2009 of the European Parliament and of the CouncilDangos y teitl llawn

Article 8 U.K. Content of the application for a certificate

1. The application for a certificate shall contain:

(a) a request for the grant of a certificate, stating in particular:

(i)

the name and address of the applicant;

(ii)

if [F1 the applicant] has appointed a representative, the name and address of the representative;

(iii)

the number of the basic patent and the title of the invention;

(iv)

[F2 the number and date of the UK, GB or NI authorisation, or where there is more than one such authorisation, of each authorisation as referred to in Article 3(b) and (d);

(v)

the number and date of the earliest of any EEA authorisation, the granting of which predates the granting of the UK , GB or NI authorisation as referred to in Article 3(b) and (d);]

[F3 (b) a copy of the UK, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation to place the product on the market, as referred to in Article 3(b) and (d), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC, Article 14 of Directive 2001/82/EC, [F4 Article 35 of Regulation (EU) 2019/6,] Part 2 to Schedule 8 of the Human Medicines Regulations 2012 or Part 1 of Schedule 1 to the Veterinary Medicines Regulations 2013;

(c) where the product is the subject of one or more EEA authorisations granted prior to the UK, GB or NI authorisation referred to in Article 3(b) and (d), the applicant must provide in relation to the earliest of any such EEA authorisations—

(i) information regarding the identity of the product thus authorised;

(ii) information regarding the legal provision under which the authorisation procedure took place; and

(iii) a copy of the notice publishing the authorisation in the appropriate official publication;]

(d) where the application for a certificate includes a request for an extension of the duration:

(i)

a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in [F5 regulation 58A(2)(a) of the Human Medicines Regulations 2012];

(ii)

[F6 details of the territory in respect of which the statement referred to in sub-paragraph (i) has been made.]

2. Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) of this Article and a reference to the application for a certificate already filed.

3. The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.

F7 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in Art. 8(1)(a)(ii) substituted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 15(a) (with reg. 7)

F2 Art. 8(1)(a)(iv)(v) substituted for Art. 8(1)(a)(iv) (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(2) (as amended by S.I. 2020/1471, regs. 1(2), 3(6)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 8(1)(b)(c) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(3) (as amended by S.I. 2020/1471, regs. 1(2), 3(7); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 8(1)(b) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 6

F5 Words in Art. 8(1)(d)(i) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(4)(a) (with reg. 69 as amended by S.I. 2020/1050, regs. 1(2), 37); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 8(1)(d)(ii) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 15(b) (with reg. 7)

F7 Art. 8(4) omitted (31.12.2020) by virtue of The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 55(5); 2020 c. 1, Sch. 5 para. 1(1)