The Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008
The Secretary of State for Health and the Minister for Health, Social Services and Public Safety, acting jointly, make the following Order in the exercise of powers conferred upon them by sections 62(1)(a) and (2) and 129(4) of the Medicines Act 1968 M1 or, in the case of the Minister, the powers conferred by those provisions and now vested in him M2. It appears to them to be necessary to make the Order in the interests of safety.
In accordance with section 129(6) of that Act, they have consulted such organisations as appear to them to be representative of interests likely to be substantially affected by this Order. In accordance with sections 62(3) and 129(7) of that Act they have consulted and taken into account the advice of the Herbal Medicines Advisory Committee M3. They have also taken into account the report of the Committee made under section 62(5) of that Act.
Citation, commencement and interpretation1.
(1)
This Order may be cited as the Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008 and shall come into force on 1st April 2008.
(2)
In article 3 —
“F1approved country for import” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;
“the Act” means the Medicines Act 1968;
“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;
F2...
F2...
Prohibition of sale, supply and importation of any medicinal product consisting of or containing Senecio2.
Except as provided for in article 3, the sale, supply or importation of any medicinal product consisting of or containing—
(a)
a plant M4 belonging to the species Senecio; or
(b)
an extract from such a plant,
is prohibited.
Exceptions to the prohibition imposed by article 23.
The prohibition imposed by article 2 shall not apply where the medicinal product is—
(a)
(i)
for external use only; and
(ii)
not a teething preparation, throat spray, throat pastille, throat lozenge, throat tablet, nasal spray or nasal inhalation or nasal drops;
(b)
sold or supplied to, or 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 M9 and 112 of the Act, or
(iv)
a sampling officer within the meaning of paragraph 1(1) of Schedule 3 to the Act M10;
F3(c)
is imported from an approved country for import, and is being, or is to be, exported to a country other than the United Kingdom; or
Amendment of the Medicines (Bal Jivan Chamcho Prohibition) (No.2) Order 19774.
(1)
The Medicines (Bal Jivan Chamcho Prohibition) (No.2) Order 1977 M11 is amended as follows.
(2)
In article 2—
(a)
“(4)
The prohibition imposed by paragraph (1) above shall not apply where the medicinal product is imported from an EEA State, if the product—
(a)
originates in an EEA State, or
(b)
originates outside the European Economic Area, but is in free circulation in member States,
and is being, or is to be, exported to a third country or an EEA State other than the United Kingdom.”; and
(b)
“(5)
For the purposes of paragraph (4)—
“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;
“third country” means any country other than an EEA State.”.
Amendment of the Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 20015.
(1)
The Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001 M12 is amended as follows.
(2)
In article 1 (citation, commencement and interpretation), in paragraph (2)—
(a)
““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;”;
(b)
omit the definitions of “EEA Agreement” and “EEA State”;
(c)
“third country” means any country other than an EEA State.”.
(3)
“(3)
The prohibition imposed by articles 2 and 3 above shall not apply where the medicinal product is imported from an EEA State, if the product—
(a)
originates in an EEA State, or
(b)
originates outside the European Economic Area, but is in free circulation in member States,
and is being, or is to be, exported to a third country or an EEA State other than the United Kingdom.”.
Amendment of the Medicines for Human Use (Kava-kava) (Prohibition) Order 20026.
(1)
The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 M13 is amended as follows.
(2)
In article 1(2)—
(a)
omit the definitions of “EEA Agreement” and “EEA State”;
(b)
“third country” means any country other than an EEA State.”.
(3)
“(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 a third country or an EEA State other than the United Kingdom.”.
Signed by authority of the Secretary of State for Health.
Department of Health
(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 Senecio or an extract from such a plant.
This prohibition is subject to exceptions.
This Order also makes minor amendments to three existing Orders made under section 62 of the Medicines Act 1968: the Medicines (Bal Jivan Chamcho Prohibition) (No.2) Order 1997 (S.I.1977/670); the Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001 (S.I.2001/1841); and the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 (S.I.2002/3170). The amendments ensure that the exception for goods in transit in the three Orders applies to goods imported from an EEA State which are to be exported to a third country or an EEA State other than the United Kingdom.
A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Copies have been placed in the libraries of both Houses of Parliament.