The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement certain provisions of Directive 2004/27/EC of the European Parliament and of the Council (“the 2004 Directive”)(1) amending Directive 2001/83/EC on the Community code for medicinal products for human use (“the 2001 Directive”) and make certain transitional provisions. They also create offences in relation to the failure by certain persons to comply with obligations of the 2001 Directive or of Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (“Regulation 726/2004”) and make consequential amendments to various enactments following the implementation of the 2004 Directive and the adoption of Regulation 726/2004.

The 2001 Directive is implemented in part by the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the 1994 Regulations”). Regulation 2 of these Regulations amends the 1994 Regulations by updating references in those Regulations to the 2001 Directive and Regulation 726/2004.

Regulation 2 of these Regulations also makes amendments to the 1994 Regulations consequential to the implementation of the 2004 Directive. The definition of a “relevant medicinal product” is amended to exclude traditional herbal medicinal products which are not required to have a marketing authorization but will be required to be registered under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005. Homoeopathic medicinal products which meet the conditions for the simplified scheme set up under Article 14(1) of the 2001 Directive are also excluded from the definition of a “relevant medicinal product”. These products are governed by the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994.

Regulation 2(3) and (13) of these regulations amend regulation 3 of, and Schedule 1 to, the 1994 Regulations under which, unless an exception in Schedule 1 to those Regulations applies, it is an offence to place a medicinal product on the market or to distribute it by way of wholesale dealing unless a marketing authorization has been granted for the product by the licensing authority or the European Commission. The effect of the amendment is that no such offence arises if the product has an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive which is inserted into the Directive by Article 1(84) of the 2004 Directive. Paragraphs (7)(b), (8), (9), (10), (11), (12) and (13)(c) of regulation 2 and regulation 4 of, and paragraphs 1 and 6 of the Schedule to, these Regulations amend various enactments to ensure that they apply to products authorized under Article 126a in the same way as they apply to products which have a marketing authorization and to ensure that certain obligations which apply to the holder of a marketing authorization also apply to a person who holds an authorization granted in accordance with Article 126a of the 2001 Directive.

Regulations 2(4) and (14)(a) amend regulation 3A of, and paragraph 1A of Schedule 3 to, the 1994 Regulations so that the borderline procedure applies to all products to which the 2001 Directive applies, i.e. including traditional herbal medicinal products and homoeopathic medicinal products which meet the conditions for the Article 14(1) simplified scheme.

Regulation 2(5) of these Regulations inserts a new regulation 3B into the 1994 Regulations to give effect to Article 5(3) of the 2001 Directive inserted by Article 1(4) of the 2004 Directive to exempt marketing authorization holders and others from civil liability arising from a recommendation or requirement of a competent authority to use in certain circumstances an authorized medicinal product for an unauthorized indication or to use an unauthorized medicinal product.

Regulation 2(6) of these Regulations amends regulation 4 of the 1994 Regulations, which make provision for applications for the grant, renewal and variation of UK marketing authorizations. The amendments implement Article 1(8) of the 2004 Directive, which substitutes Article 10 of the 2001 Directive, which is concerned with applications for marketing authorizations for “generic medicinal products”. In addition they remove the requirement to provide 26 copies of an application and accompanying material.

Regulation 2(7) of these Regulations amends regulation 5 of the 1994 Regulations. These give effect to the provisions concerning the renewal and validity of marketing authorizations in Article 24 of the 2001 Directive, as replaced by Article 1(23) of Directive 224/27/EC and provide for the period of validity of an authorization granted in accordance with Article 126a of the 2001 Directive.

Regulation 2(13)(a) and (b) of these Regulations amends paragraphs 1 and 2 of Schedule 1 to the 1994 Regulations, which implement Article 5(1) of the 2001 Directive, so as to provide that products which may be supplied without a marketing authorization in accordance with those paragraphs must be supplied in order to fulfil the special needs of individual patients and, if manufactured or assembled in the UK or imported into the UK from a third country, must be manufactured, assembled or imported by the holder of a manufacturer’s licence relating to products to which paragraph 1 of Schedule 1 to the 1994 Regulations applies or have been manufactured, assembled or imported for the purposes of a clinical trial by the holder of a manufacturing authorization for such products.

Regulation 2(14) of these Regulations amends Schedule 3 to the 1994 Regulations which create certain criminal offences in connection with the obligations of applicants for, and holders of, marketing authorizations and other persons arising under the relevant Community provisions. The amendments create new offences for breaches of the new obligations inserted into the 2001 Directive by the amendments made by the 2004 Directive; in particular the amendments made by Article 1(8), (22), (57) and (76) of the 2004 Directive. In addition the amendments create new offences for breaches of obligations relating to Community marketing authorizations under Articles 13(4), 16 and 26 of Regulation (EC) No. 726/2004. Regulation 2(14)(i) amends Schedule 3, so as to extend the offences relating to UK marketing authorizations to authorizations granted in accordance with new Article 126a of the 2001 Directive. Regulation 2(14)(d) makes it a criminal offence for a person to distribute a relevant medicinal product by way of wholesale dealing, if it does not have a marketing authorization.

Regulation 2(15) of these regulations amends the 1994 Regulations so as to make transitional provision for the application of the amendments relating to the labelling of medicinal products made by Article 1(40), (41) and (42) of the 2004 Directive.

Regulation 3 of these Regulations amends section 60 of the Patents Act 1977 so as to implement Article 10(6) of the 2001 Directive, substituted by Article 1(8) of the 2004 Directive, and Article 13(6) of Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, substituted by Article 1(6) of Directive 2004/28/EC. These Articles provide that the conduct of tests and trials for the purposes of Article 10(1) to (4) of the 2001 Directive (applications for generic medicinal products), and the consequential practical requirements, shall not be regarded as contrary to patent rights for medicinal products.

Regulation 4 and the Schedule to these regulations make provision for consequential amendments to other enactments.

A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in relation to the implementation of the 2004 Directive, have been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ No. L136, 30.4.2004, p.85.