Explanatory note

These Regulations amend the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the principal Regulations”) which came into force on 14 February 1994 and introduced a new, simplified registration procedure for the marketing of certain homoeopathic medicinal products for human use.

These Regulations reduce by 5% the fees payable under Part III of the principal Regulations in respect of applications for the grant of (regulation 4), and for variations of (regulation 3), certificates of registration granted under the principal Regulations.

In addition these Regulations remove an anomaly in the principal Regulations. Regulation 5(4) of the principal Regulations prescribes the cases in which the licensing authority must, before refusing to grant a certificate of registration, consult the Advisory Board on the Registration of Homoeopathic Products. Regulation 2 of these Regulations substitutes a new regulation 5(4) of the principal Regulations in order to exclude from that duty to consult the case where a refusal of a certificate is required by virtue of regulation 5(2)(c) of the principal Regulations on the ground that the product has an insufficient degree of dilution within the meaning of regulation 5(3).