The Medicines for Human Use (Fees Amendments) Regulations 2006

Explanatory Note

(This note is not part of the Regulations)

These Regulations make further amendments to the Medicines (Products for Human Use—Fees) Regulations 1995 (“the principal Regulations”) and the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Regulations”).

The principal Regulations make provision for the fees payable under the Medicines Act 1971, and other fees payable in respect of Community obligations, relating to marketing authorizations, licences and certificates in respect of medicinal products for human use. Regulations 2 to 4 amend the principal Regulations so as to provide for the capital fees payable in connection with an application for the grant or variation of a marketing authorization for a “national homoeopathic medicinal product”, and the periodic fee payable in connection with the holding of such an authorization. A national homoeopathic product is homoeopathic medicinal product which is not eligible for the procedure for registration under the Homoeopathic Regulations and is indicated only for the treatment of minor symptoms or conditions.

The Homoeopathic Regulations implemented in part Council Directive 92/73/EEC(1) (now repealed and re-enacted in Directive 2001/83/EC(2)) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human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. Regulation 5 amends Schedule 2 to the Regulations (fees for application for the grant of certificates of inspection) so that reduced fees are payable in respect of applications for certificates of registration in respect of products that have an identical formulation to, or are prepared from a homoeopathic stock identical to another homoeopathic stock used in the preparation of, a national homoeopathic product in respect of which a marketing authorization has been granted.

A full Regulatory Impact Assessment of the effect that this instrument will have on the costs of business has 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.