Statutory Instruments
MEDICINES
Made
18th December 2002
Laid before Parliament
23rd December 2002
Coming into force
13th January 2003
As respects England, Wales and Scotland, 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 section 62(1)(a) and (2) of the Medicines Act 1968M1 or, as the case may be, the powers conferred by those provisions and now vested in themM2, 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 ActM3, and after taking into account the report of the Medicines Commission made under section 62(5) of that Act, hereby make the following Order:
Marginal Citations
M11968 c.67; the expression “the appropriate Ministers” and the expression “the Health Ministers”, which are relevant to the powers being exercised in the making of this Order, are defined in section 1 of that Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 and by article 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142.
M2In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388, and articles 2(1) and 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142; and in the case of the Department of Health, Social Services and Public Safety, the powers vested in the Minister in charge of that Department by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to the Northern Ireland Act 1998 (c.47) may now be exercised by the Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1); the Department was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).
M3Section 62(3) refers to the “appropriate committee”, which is defined in section 4(6) of the Act. The Committee on Safety of Medicines was established under section 4 of the Act, by S.I. 1970/1257, for the purposes set out in that instrument.
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;
[F1“approved country for import” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;]
F2...
F2...
“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;
F3...
“medicinal product” does not include a medicinal product which is a veterinary drug.
F3...
Textual Amendments
F1Words in art. 1 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 6(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in art. 1(2) omitted (1.4.2008) by virtue of The Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008 (S.I. 2008/548), arts. 1(1), 6(2)(a)
F3Words in art. 1 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 6(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
2. Subject to article 3 below, the sale, supply or importation of any medicinal product consisting of or containing—
(a)a plant M4 belonging to the speciesPiper methysticum (known as Kava-kava); or
(b)an extract from such a plant,
is prohibited.
Marginal Citations
M4 “Plant” includes part of a plant;see the definition of “plant” in section 132(1) of the Act.
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 M5 or Article 2(2) of the Food Safety (Northern Ireland) Order 1991 M6,
(ii)a food analyst or food examiner within the meaning of section 30 of the Food Safety Act 1990 M7 or Article 30 or 31 of the Food Safety (Northern Ireland) Order 1991 M8,
(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 M9;
[F4(c)imported from an approved country for import, and is being, or is to be, exported to a country other than the United Kingdom; or]
(d)the subject [F5of a [F6UK marketing authorisation, certificate of registration or traditional herbal registration] within the meaning of the Human Medicines Regulations 2012.]
Textual Amendments
F4Art. 3(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 6(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in art. 3(d) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 77 (with Sch. 32)
F6Words in art. 3(d) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 6(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
Marginal Citations
M51990 c.16; section 5(6) was amended by paragraphs 7 and 8 of Schedule 5 to the Food Standards Act 1999 (c.28).
M6S.I. 1991/672 (N.I. 7); article 2(2) was amended by articles 3(1) and 7(1) of the Food Safety (Amendment) (Northern Ireland) Order 1996 (S.I. 1996/1633 (N.I. 12)) and paragraphs 26 and 29 of Schedule 5 to, and Schedule 6 to, the Food Standards Act 1999.
M7Section 30 was amended by paragraphs 7 and 8 of Schedule 5 to the Food Standards Act 1999.
M8Article 31 was amended by paragraphs 26 and 35 of Schedule 5 to the Food Standards Act 1999.
M9Schedule 3 was amended by paragraph 12 of Schedule 3 to the Food Safety Act 1990.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
D. C. Gowdy
Permanent Secretary,
Department of Health, Social Services and Public Safety
(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;U.K.
(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;U.K.
(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;U.K.
(d) where the product is the subject of a product licence, marketing authorization or homoeopathic certificate of registration.U.K.
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.