(This note is not part of the Order)
This Order prohibits the sale, supply or importation of any medicinal product for human use which consists of or contains a plant (or part of a plant) belonging to the speciesPiper methysticum (known as Kava-kava) or an extract from such a plant.
This prohibition is subject to the following exceptions—
a
where the product is for external use only;
b
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;
c
where the product is imported from an EEA State, if it originates from such a State or originates outside the EEA but is in free circulation in Member States (within the meaning of Article 23.2, when read with Article 24, of the EC Treaty), and is being, or is to be, exported to an EEA State other than the United Kingdom;
d
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 Article 8 of the European Parliament and Council Directive 98/34/EC (OJ No. L204, 21.7.1998, p.37), as amended by Article 1(4) of the European Parliament and Council Directive 98/48/EC (OJ No. L217, 5.8.1998, p.18).
A Regulatory Impact Assessment in relation to this Order has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.