Regulation 4 Insertion of Part IIIA into the principal Regulations

After Part III of the principal Regulations (capital fees for applications for variations of licences or certificates and for associated inspections), there shall be inserted the following–

“PART IIIA

CAPITAL FEES FOR RENEWALS OF CERTAIN PRODUCT LICENCES

Fees payable

9A

(1)

In connection with an application for the renewal of a product licence in respect of a blood product, an immunological product or a radiopharmaceutical, in respect of which a notice has been served under section 24(1A) of the Act, there shall be payable by the applicant, subject to paragraphs (2) and (3) and to regulation 19, a fee of £5,000.

(2)

Where the application is for the renewal of a product licence granted on an application which was accompanied by–

(a)

reports, each drawn up and signed by an expert having the necessary technical or professional qualifications in accordance with Article 2 of Council Directive 75/319/EEC^f1; and

(b)

a summary of product characteristics in accordance with Article 4a of Council Directive 65/65/EEC^f2;

the fee payable under paragraph (1), subject to paragraph (3), shall be £2,000.

(3)

Where an application for the renewal of a product licence referred to in paragraph (1) is in respect of more than one such licence each relating to a medicinal product containing the same active ingredient or combination of ingredients, the fee payable shall be–

(a)

in connection with the first application considered by the licensing authority, the appropriate amount specified in paragraphs (1) or (2) above;

(b)

in connection with each additional application relating to a different strength of active ingredient or a different combination of ingredients and where no further medical, scientific or pharmaceutical assessment is required, £1,000.

(4)

In this Part of these Regulations, “active ingredient” shall have the same meaning as in Schedule 1.”.