The Medicines (Products for Human Use) (Fees) Regulations 2013

PART 3 Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections

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

12.—(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 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 29 and 31 to 36.

(2) Unless regulation 31 applies, the fee in paragraph (1) is payable by the applicant.

Fee for applications for additional copy certificates

13.  The fee payable by an applicant for a certified copy of a certificate issued under Article 111(5) of the 2001 Directive is £68.

Fees for applications for certificates and copy certificates by exporters of medicinal products

14.—(1) The fee payable by an applicant for a certificate issued under regulation 31 (certification of manufacturer’s licence) of the Human Medicines Regulations, is—

(a) £152, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and

(b) £68 in any other case.

(2) The fee in paragraph (1)(a) and (b) is for three identical signed certificates.

(3) The fee payable by the applicant for a certified copy of the certificate referred to in paragraph (1) is £34.