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.

Regulation 2(3) substitutes regulation 5(3) of the principal Regulations, in order to make it clearer. Regulation 5(3) sets out the criteria for determining whether a product is to be considered to have a sufficient degree of dilution to guarantee its safety: regulation 5(2) of the principal Regulations requires the licensing authority to refuse to grant a certificate of registration in respect of a homoeopathic medicinal product if the product does not have that sufficient degree of dilution.

Regulation 3 substitutes regulation 9(2) of the principal Regulations to require the licensing authority to consult the Advisory Board on the Registration of Homoeopathic Products before revocation, as well as before nsion, of a certificate of registration (except in cases of emergency). Regulations 2(2) and 4 make drafting amendments.