The Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008

• Citation: S.I. 2008/548
• Sections: 6

Section 1 Citation, commencement and interpretation

(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 —

“ approved 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;

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Section 2 Prohibition of sale, supply and importation of any medicinal product consisting of or containing Senecio

Except as provided for in article 3, the sale, supply or importation of any medicinal product consisting of or containing—

(a) a plant belonging to the species Senecio ; or

(b) an extract from such a plant,

is prohibited.

Section 3 Exceptions to the prohibition imposed by article 2

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 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 paragraph 1(1) of Schedule 3 to the Act ;

(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

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

Section 4 Amendment of the Medicines (Bal Jivan Chamcho Prohibition) (No.2) Order 1977

(1) The Medicines (Bal Jivan Chamcho Prohibition) (No.2) Order 1977 is amended as follows.

(2) In article 2—

(a) for paragraph (4) substitute —

(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.

(b) after paragraph (4), insert —

(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.

Section 5 Amendment of the Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001

(1) The Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001 is amended as follows.

(2) In article 1 (citation, commencement and interpretation), in paragraph (2)—

(a) after the definition of “the Act”, insert —

“ 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) after the definition of “medicinal product”, insert —

third country” means any country other than an EEA State.

(3) In article 4, for paragraph (3), substitute —

(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.

Section 6 Amendment of the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002

(1) The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 is amended as follows.

(2) In article 1(2)—

(a) omit the definitions of “EEA Agreement” and “EEA State”;

(b) after the definition of “medicinal product”, insert —

third country” means any country other than an EEA State.

(3) In article 3, for paragraph (c), substitute the following—

(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.