Statutory Instruments

2002 No. 3170

MEDICINES

The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002

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 1968 or, as the case may be, the powers conferred by those provisions and now vested in them , 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 Act , and after taking into account the report of the Medicines Commission made under section 62(5) of that Act, hereby make the following Order:

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;
“ approved country for import ” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;
...
...
“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;
...
“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 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 or Article 2(2) of the Food Safety (Northern Ireland) Order 1991 ,

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

(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 ;

(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 of a UK marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the Human Medicines Regulations 2012.

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

footnote	commentary	related provisions	insert/omit
F1	Words 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)		inserted
F2	Words 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)		omitted
F3	Words 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)		omitted
F4	Art. 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)		substituted
F5	Words 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 )	this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary.	substituted
F6	Words 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)		substituted
M1	1968 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 .
M2	In 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) .
M3	Section 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.
M4	“Plant” includes part of a plant; see the definition of “plant” in section 132(1) of the Act.
M5	1990 c.16 ; section 5(6) was amended by paragraphs 7 and 8 of Schedule 5 to the Food Standards Act 1999 (c.28) .
M6	S.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.
M7	Section 30 was amended by paragraphs 7 and 8 of Schedule 5 to the Food Standards Act 1999.
M8	Article 31 was amended by paragraphs 26 and 35 of Schedule 5 to the Food Standards Act 1999.
M9	Schedule 3 was amended by paragraph 12 of Schedule 3 to the Food Safety Act 1990.

Defined Term	Section/Article	ID
approved country for import	art. 1.	legTermheKoXFPr
external use	art. 1.	external_u_rtRveyl
for external use	art. 1.	for_extern_rtUmKxq
medicinal product	art. 1.	medicinal__rtsGo8D
the Act	art. 1.	the_Act_rthRjqY

Defined Term

Section/Article

Scope of Application

approved country for import

art. 1.

legTermheKoXFPr

external use

art. 1.

external_u_rtRveyl

for external use

art. 1.

for_extern_rtUmKxq

medicinal product

art. 1.

medicinal__rtsGo8D

the Act

art. 1.

the_Act_rthRjqY

Changes that affect	Made by
The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002	2002 No. 3170	Blanket amendment	words substituted	The Treaty of Lisbon (Changes in Terminology) Order 2011	2011 No. 1043	art. 3 - 6 8 - 10	See note

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Note

The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002