The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Medicines (Products for Human Use) (Fees) Regulations 2009 (S.I. 2009/389) (“the Fees Regulations 2009”). The Fees Regulations 2009 make provision for the fees payable relating to marketing authorizations, licences and certificates in respect of medicines for human use.

These Regulations amend the provisions relating to fees which are payable for an application to vary the terms of marketing authorisations for medicinal products. These Regulations do not increase the rate of fees payable but amend provisions regarding the grouping of variations in respect of which a fee may be payable to vary marketing authorizations which were granted in accordance with Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use and in accordance with national procedures under the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (S.I. 1994/3144).

Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ No. L334, 12.12.2008 p.7) establishes a new framework regarding the classification into different categories of variations to marketing authorisations depending on level of risk to the public and the impact on the quality, safety and efficacy of the medicinal product concerned.

Part 2 of these Regulations amends the Fees Regulations 2009 in respect of those provisions relating to the payment of fees for an application to vary the terms of a marketing authorization. Regulations 4 and 7(8) respectively insert a new regulation 18A and new paragraph 35A of Schedule 1 in respect of the specified fee payable. Separate fees are specified in respect of an application for variation to the terms of a marketing authorization which is within the scope of EC Regulation No 1234/2008 and an application for variation to the terms of a marketing authorization which is not within the scope of that Regulation and which is a change made in accordance with the “UK National MA Variations Guidance” published by the MHRA on behalf of the licensing authority and available on the MHRA website on 30 November 2009.

Regulation 6 inserts a new regulation 20A which makes provision relating to the application and classification of groups of variations. Regulations 4, 6 and 7(7) relate to the procedural changes and the ability to group variations to the terms of marketing authorizations laid down in Commission Regulation (EC) No 1234/2008. Regulation 6(6) provides that a separate fee is not payable for a variation which is wholly consequential upon another variation.

Regulations 3, 5, 7(1) to (7), (9), (10), (12), (14) and (15) make amendments which are a consequence of the new groupings of variations in respect of which fees are payable and as a consequence of the “Guidance on changes to labelling and patient information for self-certification” and “Guidance on changes to labelling for self certification – compliance with article 56(a) – inclusion of Braille on the labelling” published by the MHRA on behalf of the licensing authority and available on the MHRA website on 9 November 2009.

Regulation 7(11) and (13) respectively insert new paragraph 46A and paragraph 47A of Schedule 1 to provide a reduction of the fee payable in cases where there are duplicate group applications to vary marketing authorizations.

Regulation 9 makes consequential amendments to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (S.I. 1994/3134) so as to refer to Commission Regulation (EC) No 1234/2008.

Regulation 10 makes savings provisions.

An impact assessment of the effect that this instrument will have on business and the voluntary sector is available from the MHRA at Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.