Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005

Explanatory Note

(This note is not part of the Regulations)

These Regulations make further amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Regulations”) and consequential amendments to the Medicines Act and other Regulations.

The Homoeopathic Regulations implemented in part Council Directive 92/73/EEC(1) (now repealed and re-enacted in Directive 2001/83/EC(2)) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. The Homoeopathic Regulations also make provision for capital fees payable for applications for the grant and variation of certificates of registration and for periodic fees payable by holders of these certificates.

Directive 2001/83/EC has now been amended by Directive 2004/27/EC(3). Regulations 5, 7, 9 and 10 to 18 and provisions in regulations 2, 6, 8, 20 and 21 in part implement the changes made by Directive 2004/27/EC.

Regulations 2, 5, 6, 13, 14, 16, 17 and 18 make changes necessitated by the extension of the mutual recognition procedure and decentralised procedure set out in Article 28 of Directive 2001/83/EC to homoeopathic medicinal products registered under the simplified scheme. In particular new capital fees for decentralised procedure and incoming and outgoing mutual recognition applications are introduced by regulations 17 and 18 which amend Schedule 2 to the Homoeopathic Regulations and insert new Schedule 2A respectively.

Regulation 9 amends regulation 8 of the Homoeopathic Regulations dealing with renewal of certificates of registration in order to implement the changes to Article 24 of Directive 2001/83/EC and the insertion of Article 23a.

Regulation 10 makes provision for the licensing authority to revoke, suspend or compulsorily vary a certificate of registration, if this is in accordance with the provisions of Directive 2001/83/EC, as required by Article 116 of the Directive.

Regulations 7, 8, 11 and 12 contain consequential amendments.

Regulations 8(3) and 20 insert a new Schedule 6 to the Homoeopathic Regulations which sets out offences for breaches of the Homoeopathic Regulations. The Schedule contains some new offences introduced to implement changes to Directive 2001/83/EC but also includes offences that were previously applied by virtue of sections 7 and 45 of the Medicines Act 1968 (the “Act”) as applied to homoeopathic medicinal products. Regulation 21 inserts Schedule 1 which amends section 7 of the Act so that this section no longer applies to medicinal products to which the Homoeopathic Regulations apply.

Regulations 15 and 20 also insert a new Schedule 7 to the Homoeopathic Regulations which provides that the requirement introduced by Directive 2004/27/EC for the name of a homoeopathic medicinal product to be in Braille format on the label, and the changes made to what information may be on the label of a product with a certificate of registration, shall not apply until 30th October 2010 for products granted a certificate of registration before 30th October 2005.

Regulation 19 and in part regulations 6, 9, 10 and 20 make provision for the procedures on applications for, and decisions in respect of, certificates of registration, in particular for consultation of a committee established under the Act, or the Commission on Human Medicines. Changes to the procedures have been made as a consequence of amendments made by the Medicines (Advisory Bodies) Regulations 2005(4) which amend the Act to, amongst other things, abolish the Medicines Commission.

Regulations 3, 4 and provisions in regulation 2 correct minor errors and omissions in the Homoeopathic Regulations.

Regulation 21 and Schedule 1 amend the Medicines (Labelling) Regulations 1976 and the Medicines (Leaflets) Regulations 1977 so that these Regulations do not apply to homoeopathic medicinal products to which the Homoeopathic Regulations apply. The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995 is amended to change the definition of a homoeopathic medicinal product (amended by Directive 2004/27/EC), to remove the reference to Directive 92/74/EEC (this Directive which related to veterinary medicinal products has been repealed), and to extend the remit of the Advisory Board on the Registration of Homoeopathic Products to include consideration of proposals to compulsorily vary a certificate of registration.

A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in relation to the implementation of Directive 2004/27/EC, 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)

OJ No. L 297, 13.10.1992, p.8.

(2)

See articles 1(5), 13 to 16, 53, 68, 69, 85, 100, 119 and 124.

(3)

Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ No. L136, 30.4.2004, p.34.

(4)

S.I. 2005/1094.