24.—(1) Article 8 (contents of the application for a certificate) is amended as follows.
(2) For paragraph 1(a)(iv), substitute—
“(iv)the number and date of the [F1GB or NI authorisation or both GB and NI authorisations] as referred to in Article 3(1)(b) [F2and (d)]; and
(v)the number and date of the earliest EEA authorization, the granting of which predates the granting of the [F3GB or NI] authorization [F4as referred to in Article 3(1)(b) and (d)];”.
(3) For paragraph 8(1)(b) and (c), substitute—
“(b)a copy of the [F5GB or NI authorisation or both GB and NI authorisations] to place the product on the market, as referred to in Article 3(1)(b) [F6and (d)], in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Commission Regulation 283/2013, [F7Part A section 1, points 1.1 to 1.7 or Part B, Section 1 points 1.1 to 1.4.3];
(c)where the product is the subject of one or more EEA authorizations granted prior to the [F8GB or NI] authorization referred to in Article 3(1)(b) [F9and (d)], the applicant must provide in relation to the earliest of any such EEA authorizations—
(i)information regarding the identity of the product thus authorised;
(ii)information regarding the legal provision under which the authorization procedure took place; and
(iii)a copy of the notice publishing the authorization in the appropriate official publication or, failing such a notice, any other document proving that the authorization has been issued, the date on which it was issued and the identity of the product authorized.”.
(4) Omit paragraph 2.
Textual Amendments
F1Words in reg. 24(2) substituted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(6)(a)(i) (with reg. 7)
F2Words in reg. 24(2) inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(6)(a)(ii) (with reg. 7)
F3Words in reg. 24(2) substituted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(6)(b)(i) (with reg. 7)
F4Words in reg. 24(2) inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(6)(b)(ii) (with reg. 7)
F5Words in reg. 24(3) substituted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(7)(a)(i) (with reg. 7)
F6Words in reg. 24(3) inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(7)(a)(ii) (with reg. 7)
F7Words in reg. 24(3) substituted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 33
F8Words in reg. 24(3) substituted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(7)(b)(i) (with reg. 7)
F9Words in reg. 24(3) inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(7)(b)(ii) (with reg. 7)
Commencement Information
I1Reg. 24 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1