PART 3Capital 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 certificates13
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 products14
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.