The Medicines (Products for Human Use-Fees) Regulations 2008

PART 7 Capital Fees for Applications for Renewals of Certain Manufacturer’s Licences and for Associated Inspections

Fees for renewals of certain manufacturer’s licences

24.—(1) Unless regulation 44 applies, the fee payable by the applicant for an application to renew a manufacturer’s licence which falls within the description in paragraph (2) is £165.

(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 authorization or a product licence; and

(b) to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(1) applies.

(3) But if an inspection of a site is made in connection with the application an inspection fee of £273 is also payable by the applicant.

Fees for renewals in terms which are not identical to the existing authorization, licence or certificate

25.  Where an applicant applies for renewal of a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturer’s licence or a wholesale dealer’s licence so as to contain provisions which are not identical to those in the authorization, registration or licence as in force at the date of the application, the fee payable under this Part of these Regulations is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had he made a separate application for variation of that authorization, registration or licence in respect of each provision which is not identical.

(1)

S.I. 1971/1450; amendments which are not relevant have been made to article 2.