2006 No. 2386
medicines

The Medicines (Advisory Board on the Registration of Homoeopathic Products) Amendment Order 2006

Made
Coming into force
The Secretary of State for Health and the Department of Health, Social Services and Public Safety, acting jointly, make the following Order in exercise of the powers conferred on them by sections 4 and 129(4) of the Medicines Act 19681 or, as the case may be, the powers conferred by that section and now vested in them2.

In accordance with section 129(6) of the Medicines Act, they have consulted such organisations as appear to them to be representative of interests likely to be substantially affected by the Order.

Citation and commencement1.

This Order may be cited as the Medicines (Advisory Board on the Registration of Homoeopathic Products) Amendment Order 2006 and shall came into force on 1st September 2006.

Amendment of the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 19952.

(1)

The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 19953 is amended as follows.

(2)

In article 1 (citation, commencement and interpretation), in paragraph (2), after the definition of “homoeopathic medicinal product” insert the following definitions—
““marketing authorization” means a marketing authorization for a national homoeopathic product granted by the licensing authority under the Marketing Authorisation Regulations4;

“national homoeopathic product” has the same meaning as in regulation 4(1B) of the Marketing Authorisation Regulations;”.

(3)

In article 2 (Advisory Board on the Registration of Homoeopathic Products)—

(a)

in paragraph (1), for the words from “the safety and quality of” to the end, substitute—

“—

(a)

the safety and quality of any homoeopathic medicinal product—

(i)

in respect of which a certificate of registration has been granted, or

(ii)

which is the subject of an application for such a certificate; and

(b)

the safety, quality and efficacy of any homoeopathic medicinal product—

(i)

in respect of which a marketing authorization has been granted,

(ii)

which is the subject of an application for such an authorization, or

(iii)

in respect of which a licence of right has been granted.”; and

(b)

omit paragraph (2).

Signed by authority of the Secretary of State for Health

Andrew Burnham
Minister of State
Department of Health

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

Andrew McCormick
Permanent Secretary
Department of Health, Social Services and Public Safety
EXPLANATORY NOTE
(This note is not part of the Order)
This Order amends the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995, to extend the functions of the Advisory Board on the Registration of Homoeopathic Products to include the provision of advice on the safety, quality and efficacy of homoeopathic medicinal products which have a product licence of right, or national homoeopathic products which have a marketing authorisation or in respect of which an application for such an authorisation is made. A national homoeopathic product is a homoeopathic medicinal product which is not eligible for the procedure for registration under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19945 and which is for the relief or treatment of minor symptoms or conditions.

A full regulatory impact assessment has not been produced for this instrument as it has no impact on the costs of business.