The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1994

Statutory Instruments

1994 No. 102

MEDICINES

The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1994

Made

23rd December 1993

Coming into force

14th February 1994

The Secretaries of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of the powers conferred by section 4 of the Medicines Act 1968(1) or, as the case may be, those conferred by the said provisions and now vested in them(2) and of all other powers enabling them in that behalf, having regard pursuant to section 4(1) of that Act to the recommendations made by the Medicines Commission under section 3(2) of that Act and after consulting such organisations as they consider appropriate pursuant to section 4(1) of that Act and those appearing to them to be representative of interests likely to be substantially affected by the following Order(3), hereby make the following Order—

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1994 and shall come into force on 14th February 1994.

(2) In this Order—

“the Act” means the Medicines Act 1968;

“certificate of registration” means a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(4);

“homoeopathic medicinal product” means a medicinal product (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State.

Establishment of the Advisory Board on the Registration of Homoeopathic Products

2.  There shall be established a committee, to be called the Advisory Board on the Registration of Homoeopathic Products, for the purpose of giving advice with respect to safety and quality of—

(a)any homoeopathic medicinal product in respect of which a certificate of registration could be granted; and

(b)any homoeopathic medicinal product which satisfies the conditions set out in Article 7 of Council Directive 92/74/EEC(5),

and to which any relevant provision of the Act is applicable.

Signed by authority of the Secretary of State for Health

Tom Sackville

Parliamentary Under-Secretary of State

Department of Health

16th December 1993

John Redwood

Secretary of State for Wales

23rd December 1993

Fraser of Caimyllie

Minister of State The Scottish Office

16th December 1993

In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 20th December 1993.

L.S.

Gillian Shephard

Minister of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 17th December 1993.

L.S.

F. A. Elliott

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 20th December 1993.

W. J. Hodges

Permanent Secretary

Explanatory Note

(This note is not part of the Order)

This Order establishes the Advisory Board on the Registration of Homoeopathic Products for the purposes set out in Article 2.

Article 1 contains definitions of “homoeopathic medicinal product” and of “certificate of registration”.

(1)

1968 c. 67.The expression “the Ministers”, used in section 4(1), is defined in section 1(1)(a) of that Act as amended by S.I.1969/388, Schedule 1.

(2)

In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I.1969/388); in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No.1) Order 1978 (S.I.1978/272); and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

(3)

See section 129(6) of the Medicines Act 1968.

(4)

S.I. 1994/105.

(5)

OJ No.L297, 13.10.92, p. 12; This Directive widens the scope of Council Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homoeopathic veterinary medicinal products.