# The Medicines (Aristolochia and Mu Tong etc.) (Temporary Prohibition) Order 2000

S.I. 2000/1368 · made 18 May 2000

This Order prohibits the sale, supply, and importation, of any medicinal product for human use which—consists of or contains a plant belonging to a species of the genus Aristolochia or belonging to any of the species: Akebia quinata, Akebia trifoliata, Clematis armandii, Clematis montana, Cocculus laurifolius, Cocculus orbiculatus, Cocculus trilobus, Stephania tetrandra, or an extract from such a plant; oris presented as consisting of or containing Mu Tong or Fangji, a plant belonging to any of the species Akebia quinata, Akebia trifoliata, Clematis armandii, Clematis montana, Cocculus laurifolius, Cocculus orbiculatus, Cocculus trilobus, Stephania tetrandra, or an extract from such a plant.

Made under: Medicines Act 1968 (Section 62, Section 129)

PDFs: Printed copy https://openlegislation.uk/medicines-aristolochia-and-mu-tong-etc-temporary-prohibition-order-2000/pdf/uksi_20001368_en.pdf

## Introductory text

MEDICINES
Made 18th May 2000
Laid before Parliament 19th May 2000
Coming into force 16th June 2000
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Department of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 62(1)(a) and (2) and 129(4) of the Medicines Act 1968 and now vested in them 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, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the Order pursuant to section 129(6) of that Act, after consulting and taking into account the advice of the Committee on Safety of Medicines pursuant to sections 62(3) and 129(7) of that Act, and after taking into account the report of the Medicines Commission made under section 62(5) of that Act, hereby make the following Order:—

## 1 Citation, commencement, expiry and interpretation

(1) This Order may be cited as the Medicines (Aristolochia and Mu Tong etc.) (Temporary Prohibition) Order 2000, shall come into force on 16th June 2000 and shall continue in force until the end of 30th June 2001, when it shall expire.
(2) In this Order—
“the Act” means the Medicines Act 1968;
“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;
“EEA State” means a State which is a Contracting Party to the EEA Agreement;
“medicinal product” does not include a medicinal product which is a veterinary drug.

## 2 Prohibition of sale, supply and importation of any medicinal product consisting of or containing certain plants

Subject to article 4 below, the sale, supply and importation of any medicinal product consisting of or containing a plant —
(a) belonging to a species of the genus Aristolochia; or
(b) belonging to any of the species—
Akebia quinata,
Akebia trifoliata,
Clematis armandii,
Clematis montana,
Cocculus laurtfolius,
Cocculus orbiculatus,
Cocculus trilobus,
Stephania tetrandra,
or consisting of or containing an extract from such a plant, is prohibited.

## 3 Prohibition of sale, supply and importation of any medicinal product presented as consisting of or containing Mu Tong etc.

Subject to article 4 below, the sale, supply and importation of any medicinal product is prohibited where, at the time of the sale, supply or importation—
(a) the label on the product’s container or package; or
(b) any document accompanying the product,
indicates in any language—
(i) that the product consists of or contains Mu Tong or Fangji, or any term derived from either of those terms; or
(ii) that the product consists of or contains a plant specified in article 2(b) above or an extract from such a plant.

## 4 Exceptions to the prohibitions imposed by articles 2 and 3 above

(1) The prohibitions imposed by articles 2 and 3 above are subject to the exceptions specified in the following paragraphs of this article.
(2) The prohibitions imposed by articles 2 and 3 above shall not apply where a medicinal product as referred to in those articles is sold or supplied to, or, in the case of importation, is imported 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 1990;
(b) a food analyst or food examiner within the meaning of Article 30 or 31 of the Food Safety (Northern Ireland) Order 1991;
(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 prohibitions on importation imposed by articles 2 and 3 above shall not apply where a medicinal product as referred to in those articles is imported—
(a) from a member State of the European Community; or
(b) where the product originates in the European Economic Area, from an EEA State which is not also a member State of the European Community.
(4) The prohibitions imposed by articles 2 and 3 above shall not apply where a medicinal product as referred to in those articles is the subject of a product licence, a marketing authorization within the meaning of regulation 1(4)(a) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 or a certificate of registration within the meaning of regulation 1(2) of the Medicines (Homoeopathic Products for Human Use) Regulations 1994.

## 5 Revocation

The Medicines (Aristolochia) (Temporary Prohibition) Order 1999 is revoked.

## Signature

Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
18th May 2000
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 18th May 2000.
L.S.
D. A. Baker
A Senior Officer of the
Department of Health, Social Services and Public Safety

## Explanatory note

(This note is not part of the Order)
This Order prohibits the sale, supply, and importation, of any medicinal product for human use which—
(a) consists of or contains a plant belonging to a species of the genus Aristolochia or belonging to any of the species: Akebia quinata, Akebia trifoliata, Clematis armandii, Clematis montana, Cocculus laurifolius, Cocculus orbiculatus, Cocculus trilobus, Stephania tetrandra, or an extract from such a plant; or
(b) is presented as consisting of or containing Mu Tong or Fangji, a plant belonging to any of the species Akebia quinata, Akebia trifoliata, Clematis armandii, Clematis montana, Cocculus laurifolius, Cocculus orbiculatus, Cocculus trilobus, Stephania tetrandra, or an extract from such a plant.
These prohibitions are subject to the following exceptions—
(i) 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;
(ii) in the case of the prohibitions on importation, where the product is imported from a member State of the European Community, or, where the product originates in the European Economic Area, from a State Party to the European Economic Area Agreement which is not also a member State;
(iii) where the product is 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, Article 8 (OJ No. L204, 21.7.1998, p.37) as amended by European Parliament and Council Directive 98/48/EC, Article 1(4) (OJ No. L217, 5.8.1998, p.18), and in accordance with Council Directive 75/319/EEC, Article 33 (OJ No. L147, 9.6.1975, p.13).
This Order revokes the Medicines (Aristolochia) (Temporary Prohibition) Order 1999 (S.I. 1999/2889). The provisions of that Order are re-enacted in this Order.
This Order shall come into force on 16th June 2000 and shall continue in force until the end of 30th June 2001, when it shall expire.

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Source: https://www.legislation.gov.uk/uksi/2000/1368 (the official version)
Page: https://openlegislation.uk/medicines-aristolochia-and-mu-tong-etc-temporary-prohibition-order-2000
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

