PART 8U.K.SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS – AMENDMENTS TO REGULATION (EC) No 469/2009

58.—(1) Article 11 (publication) is amended as follows.

(2) In paragraphs 1 and 2, for “the authority referred to in Article 9(1)” substitute “ the comptroller ”.

(3) In paragraph 1—

(a)[F1for paragraph (d), insert—

(d)the number and date of the UK, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation provided under Article 8(1)(b) or Article 13A(1), the product identified in the authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;];

(b)for sub-paragraph (e), substitute—

(e)where there are EEA authorisations granted before [F2any UK, GB or NI authorisation provided under Article 8(1)(b)], the number and date of the earliest EEA authorisation;.

Textual Amendments

F1Words in reg. 58(3)(a) substituted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(10)(a) (with reg. 7)

Commencement Information

I1Reg. 58 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1