1999 No. 2109
MEDICINES

The Medicines (Aristolochia) (Emergency Prohibition) Order 1999

Made
Laid before Parliament
Coming into force
The Secretaries of State concerned with health in England, in Wales and in Scotland respectively and the Department of Health and Social Services for Northern Ireland, acting jointly, in exercise of the powers conferred upon them by sections 62(1)(a), (2) and (3) and 129(6) of the Medicines Act 19681 and now vested in them2 and of all other powers enabling them in that behalf, it appearing to them to be necessary in the interests of safety to make the following Order, and their being of the opinion that it is essential to make the Order with immediate effect to avoid serious danger to the health of human beings, and after taking into account the advice of the Committee on Safety of Medicines and the Medicines Commission pursuant to section 129(7) of that Act3, hereby make the following Order:—

Citation, commencement, expiry and interpretation1.

(1)

This Order may be cited as the Medicines (Aristolochia) (Emergency Prohibition) Order 1999, shall come into force on 28th July 1999 and shall continue in force until the end of 27th October 1999, when it shall expire.

(2)

In this Order, “the Act” means the Medicines Act 1968.

Prohibition of sale, supply and importation of medicinal products consisting of or containing Aristolochia2.

(1)

Subject to paragraphs (2), (3) and (4) below, the sale, supply, and importation of any medicinal products consisting of or containing a plant4 belonging to a species of the genus Aristolochia, or any extracts from such a plant, is prohibited.

(2)

The prohibition imposed by paragraph (1) above shall not apply to the sale, supply or importation of the medicinal products referred to where the sale or supply is to, or, in the case of importation, the importation is made by or on behalf of, any of the following persons—

(a)

a food analyst or food examiner within the meaning of section 30 of the Food Safety Act 19905;

(b)

a food analyst or food examiner within the meaning of Article 30 or 31 of the Food Safety (Northern Ireland) Order 19916;

(c)

an authorised officer within the meaning of section 5(6) of the Food Safety Act 1990, or Article 2(2) of the Food Safety (Northern Ireland) Order 1991;

(d)

a person duly authorised by an enforcement authority under sections 111 and 112 of the Act;

(e)

a sampling officer within the meaning of Schedule 3 to the Act.

(3)

The prohibition on importation imposed by paragraph (1) above shall not apply to the importation of the medicinal products referred to—

(a)

from a member State of the European Community, or

(b)

if the products originated in an EEA State within the meaning of Article 9 of, and Protocol 4 to, the Agreement on the European Economic Area signed at Oporto on 2nd May 19927, as adjusted by the Protocol signed at Brussels on 17th March 19938, from an EEA State other than a member State.

(4)

The prohibition imposed by paragraph (1) above shall not apply to the sale, supply or importation of the medicinal products referred to where the products are the subject of a product licence9, a marketing authorization within the meaning of regulation 1(4)(a) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 199410 or a certificate of registration within the meaning of regulation 1(2) of the Medicines (Homoeopathic Products for Human Use) Regulations 199411.

Signed by authority of the Secretary of State for Health

Hayman
Parliamentary Under Secretary of State
Department of Health

Signed by authority of the Secretary of State for Wales

Jon Owen Jones
Parliamentary Under Secretary of State Welsh Office
Calum MacDonald
Parliamentary Under Secretary of State Scottish Office

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

D. C. Gowdy
Permanent Secretary
(This note is not part of the Order)

This Order prohibits the sale, supply, and importation, of medicinal products consisting of or containing a plant belonging to a species of the genus Aristolochia, or extracts from such a plant.

Those prohibitions are subject to the following exceptions—

(a)

where the sale or supply is to, or the importation is made by or on behalf of, a person exercising functions in relation to the enforcement of food or medicines legislation;

(b)

in the case of the prohibition on importation, where the products are imported from a member State of the European Community, or, where the products originate in a State party to the European Economic Area Agreement (EEA State), from an EEA State other than a member State,

(c)

where the products are the subject of a product licence, marketing authorization or homoeopathic certificate of registration.

This Order was notified to the European Commission in accordance with European Parliament and Council Directive 98/34/EC (OJ No. L204, 22.7.1998, p.37/48) as amended by European Parliament and Council Directive 98/48/EC (OJ No. L217, 5.8.1998, p.18/26).

The Order shall come into force on 28th July 1999, and shall expire at the end of 27th October 1999.