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.