The Medicines (Products for Human Use) (Fees) Regulations 2016

PART 7 U.K. Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections

Fees for renewals of certain manufacturer's licences U.K.

27.—(1) The fee payable by the applicant for an application to renew a manufacturer's licence which falls within the description in paragraph (2) is [F1 £214].

(2) The licence referred to in paragraph (1) is one—

(a) which is solely for the manufacture of medicinal products the sale or supply of which does not require a marketing authorisation or a product licence; and

(b) to which regulation 169 (mixing of general sale medicinal products) of the Human Medicines Regulations applies.

(3) Where an inspection of a site is made in connection with the application referred to in paragraph (1) an inspection fee of [F2 £325] is also payable by the applicant.

Textual Amendments

F1 Sum in reg. 27(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 22

F2 Sum in reg. 27(3) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 20(b)

[F3 Fee for renewals of a marketing authorisation U.K.

27A.   Where an application is made to the licensing authority for the renewal of a marketing authorisation in the case of a product for sale or supply in Great Britain and the application for renewal—

(a) relates to a medicinal product which, at the time the marketing authorisation was granted, contained a new active ingredient; and

(b) is the first renewal in relation to that product,

the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 2.]

Textual Amendments

F3 Reg. 27A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 4 (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(e)); 2020 c. 1, Sch. 5 para. 1(1)

Fees for renewals in terms which are not identical to the existing authorisation, licence or registration U.K.

28.  Where an applicant applies for renewal of a—

(a) marketing authorisation (other than a European Union marketing authorisation);

(b) traditional herbal registration, or

(c) manufacturer's licence,

so as to contain provisions which are not identical to those in the authorisation, registration or licence as in force at the date of the application, the fee payable under this Part is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had the applicant made a separate application for variation of that authorisation, registration or licence in respect of each provision which is not identical.