Paragraph 57 Renewal of multiple marketing authorisationsF1

(1)

This sub-paragraph applies if more than one application falling within regulation 27A is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form and therapeutic indications, and the marketing authorisations for those products have the same date for renewal.

(2)

The fee payable under regulation 27A for applications to which sub-paragraph (1) applies is—

(a)

in respect of applications for renewal of more than one UKMA(GB) granted under the unfettered access route or UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding renewal application has been made to the related European Union marketing authorisation or UKMA(NI) for the same product—

(i)

F2£1,239 for the first application considered by the licensing authority; and

(ii)

F3£1,239 for each other application;

(b)

in all other cases—

(i)

F4£16,042 for the first application considered by the licensing authority; and

(ii)

F5£822 for each other application.

Annotations

Textual amendments

F1: Sch. 2 Pts. 6-6B, substituted for Sch. 2 Pt. 6 (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(13) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ix)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Sum in Sch. 2 para. 57(2)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(28)(a)
F3: Sum in Sch. 2 para. 57(2)(a)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(28)(a)
F4: Sum in Sch. 2 para. 57(2)(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(28)(b)
F5: Sum in Sch. 2 para. 57(2)(b)(ii) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(28)(c)