Statutory Instruments
2001 No. 1841
MEDICINES
The Medicines (Aristolochia and Mu Tong etc. ) (Prohibition) Order 2001
Made
9th May 2001
Laid before Parliament
10th May 2001
Coming into force
1st July 2001
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Minister of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 62(1)(a) and (2) and 129(4) of the Medicines Act 1968( 1 ) and now vested in them( 2 ) 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( 3 ), 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 (Aristolochia and Mu Tong etc.) (Prohibition) Order 2001, and shall come into force on 1st July 2001.
(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;
...
...
...
“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 certain plants
2. Subject to article 4 below, the sale, supply and importation of any medicinal product consisting of or containing a plant( 4 )—
(a) belonging to a species of the genus Aristolochia; or
(b) belonging to any of the species—
Akebia quinata,
Akebia trifoliata,
Clematis armandii,
Clematis montana,
Cocculus laurifolius,
Cocculus orbiculatus,
Cocculus trilobus,
Stephania tetrandra,
or consisting of or containing an extract from such a plant, is prohibited.
Prohibition of sale, supply and importation of medicinal products presented as consisting of or containing Mu Tong etc.
3. Subject to article 4 below, the sale, supply and importation of any medicinal product is prohibited where, at the time of the sale, supply or importation—
(a) the label on the product’s container or package; or
(b) any document accompanying the product,
indicates in any language—
(i) that the product consists of or contains Mu Tong or Fangji, or any term derived from either of those terms; or
(ii) that the product consists of or contains a plant specified in article 2(b) above or an extract from such a plant.
Exceptions to the prohibitions imposed by articles 2 and 3 above
4. —(1) The prohibitions imposed by articles 2 and 3 above are subject to the exceptions specified in the following paragraphs of this article.
(2) The prohibitions imposed by articles 2 and 3 above shall not apply where a medicinal product as referred to in those articles is sold or supplied to, or, in the case of importation, is imported by or on behalf of, any of the following persons—
(a) a food analyst or food examiner within the meaning of section 30 of the Food Safety Act 1990( 5 );
(b) a food analyst or food examiner within the meaning of Article 30 or 31 of the Food Safety (Northern Ireland) Order 1991( 6 );
(c) 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( 7 );
(d) a person duly authorised by an enforcement authority under sections 111 and 112 of the Act;
(e) a sampling officer within the meaning of Schedule 3 to the Act.
(3) The prohibition imposed by articles 2 and 3 does not apply where the medicinal product—
(a) is imported from an approved country for import; and
(b) is being, or is to be, exported to a country other than the United Kingdom.
(4) The prohibitions imposed by articles 2 and 3 above shall not apply where a medicinal product as referred to in those articles is the subject of a product licence( 8 ), a UK marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the Human Medicines Regulations 2012.
Revocation
5.The Medicines (Aristolochia and Mu Tong etc.) (Temporary Prohibition) Order 2000( 9 ) is revoked.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
Bairbre de Brún
Minister of Health, Social Services and Public Safety
1968 c. 67 ; the expression “the appropriate Ministers”, and the expression “the Health Ministers” which is 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 .
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 Minister of Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) .
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.
“Plant” includes part of a plant; see section 132(1) of the Act.
1990 c. 16 ; section 30 was amended by section 40 of, and paragraph 8 of Schedule 5 to, the Food Standards Act 1999 (c. 28) .
S.I. 1991/762 (N.I. 7) ; as amended by S.I. 1996/1633 (N.I. 12) .
Section 5(6) was amended by section 40 of, and paragraph 8 of Schedule 5 to, the Food Standards Act 1999 (c. 28) , and article 2(2) was amended by paragraph 29 of Schedule 5 to, and Schedule 6 to, that Act.
“Product licence” has the meaning assigned to it by section 7 of the Act.
S.I. 2000/1368 .