Regulation 12 Fees for applications for authorisations, registrations, licences or certificates etc.

(1)

Unless Part 16 of these Regulations (revocations and savings) applies, the application fee for a marketing authorisation (other than a European Union marketing authorisation), a parallel import licence, a traditional herbal registration, a manufacturer's licence, a manufacturing authorisation, a wholesale dealer's licence, a clinical trial authorisation, a broker's registration F1, an application under the Early Access to Medicines Scheme or an active substance registration is—

(a)

the fee prescribed for that application in Part 2 of Schedule 2; and

(b)

in respect of an inspection of a site made in connection with that application, the fee payable in accordance with regulations 30 and 32 to 37.

(2)

Unless regulation 32 applies, the fee in paragraph (1) is payable by the applicant.

Annotations

Textual amendments

F1: Words in reg. 12(1) inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 10