- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
4. 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–
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(1); and
(b)a summary of product characteristics in accordance with Article 4a of Council Directive 65/65/EEC(2);
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.”.
OJ No. L147, 9.6.1975, p.13.
OJ No. 22, 9.2.1965, p.369/65, as inserted by Council Directive 83/570/EEC OJ No. L332, 28.11.1983.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include: