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

• Citation: S.I. 2000/1368
• Sections: 5

Section 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.

Section 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.

Section 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.

Section 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 .

Section 5 Revocation

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