The Medicines (Products for Human Use — Fees) Regulations 1991

PART IV CAPITAL FEES FOR APPLICATIONS FOR RENEWALS OF CLINICAL TRIAL CERTIFICATES AND FOR CERTAIN MANUFACTURERS' LICENCES AND FOR ASSOCIATED INSPECTIONS

Renewals of clinical trial certificates

10.  Subject to regulations 12, 19 and 23, in connection with an application under section 38(2) of the Act for renewal of a clinical trial certificate, there shall be payable by the applicant a fee of £3,500.

Renewals of certain manufacturers' licences

11.—(1) Subject to regulations 12 and 23, the fee payable in connection with an application for renewal of a manufacturer’s licence which is limited solely to the manufacture or assembly of medicinal products, the sale or supply of which do not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(1) applies shall be £80.

(2) In respect of any inspection made in connection with an application referred to in paragraph (1), the fee payable shall be that prescribed in paragraph 2(d) of Schedule 2.

Renewals in terms which are not identical to the existing certificate or licence

12.  Where an applicant applies for the renewal of a certificate or licence so as to contain provisions which are not identical to that certificate or licence as in force at the date of that application, he shall pay, in addition to any fee otherwise payable in respect of that renewal under this Part of these Regulations, a fee equal to the fee which would have been payable under Part III of these Regulations had he made a separate application for each variation of that certificate or licence.

(1)

S.I. 1971/1450; there are no relevant amending instruments.