Citation, commencement and interpretation

1.—(1) This Order may be cited as the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 and shall come into force on 13th January 2003.

(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(4) as adjusted by the Protocol signed at Brussels on 17th March 1993(5);

“EEA State” means a State which is a Contracting Party to the EEA Agreement;

“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur, and references to medicinal products being “for external use” shall be read accordingly—except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

“free circulation in member States” has the same meaning as in Article 23.2, as read with Article 24, of the Treaty establishing the European Community; and

“medicinal product” does not include a medicinal product which is a veterinary drug.

Prohibition of sale, supply and importation of any medicinal product consisting of or containing Piper methysticum (known as Kava-kava)

2.  Subject to article 3 below, the sale, supply or importation of any medicinal product consisting of or containing—

(a)a plant(6) belonging to the species Piper methysticum (known as Kava-kava); or

(b)an extract from such a plant,

is prohibited.

Exceptions to the prohibition imposed by article 2

3.  The prohibition imposed by article 2 above shall not apply where the medicinal product is—

(a)for external use only;

(b)sold or supplied to, or is imported by or on behalf of, any of the following persons—

(i)an authorised officer within the meaning of section 5(6) of the Food Safety Act 1990(7) or Article 2(2) of the Food Safety (Northern Ireland) Order 1991(8),

(ii)a food analyst or food examiner within the meaning of section 30 of the Food Safety Act 1990(9) or Article 30 or 31 of the Food Safety (Northern Ireland) Order 1991(10),

(iii)a person duly authorised by an enforcement authority under sections 111 and 112 of the Act, or

(iv)a sampling officer within the meaning of Schedule 3 to the Act(11);

(c)imported from an EEA State, if the product—

(i)originates in an EEA State, or

(ii)originates outside the European Economic Area, but is in free circulation in member States,

and is being, or is to be, exported to an EEA State other than the United Kingdom; or

(d)the subject of—

(i)a product licence(12),

(ii)a marketing authorization within the meaning given in regulation 1(4)(a) of the Medicines for Human Use (Marketing Authorisation Etc.) Regulations 1994(13), or

(iii)a certificate of registration within the meaning given in regulation 1(2) of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(14).

Explanatory Note

(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 species Piper 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.