Article 2 Prohibition of sale, supply and importation of any medicinal product consisting of or containing Aristolochia

(1)

Subject to paragraphs (2), (3) and (4) below, the sale, supply and importation of any medicinal product consisting of or containing a plant^f1 belonging to a species of the genus Aristolochia, or any extract from such a plant, is prohibited.

(2)

The prohibition imposed by paragraph (1) above shall not apply where a medicinal product as referred to in that paragraph 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^f2;

(b)

a food analyst or food examiner within the meaning of Article 30 or 31 of the Food Safety (Northern Ireland) Order 1991^f3;

(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;

(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 on importation imposed by paragraph (1) above shall not apply where a medicinal product as referred to in that paragraph is imported–

(a)

from a member State of the European Community; or

(b)

where the product originates^f4 in the European Economic Area, from an EEA State which is not also a member State of the European Community.

(4)

The prohibition imposed by paragraph (1) above shall not apply where a medicinal product as referred to in that paragraph is the subject of a product licence^f5, a marketing authorization within the meaning of regulation 1(4)(a) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994^f6 or a certificate of registration within the meaning of regulation 1(2) of the Medicines (Homoeopathic Products for Human Use) Regulations 1994^f7.

Annotations

Footnotes

f1: “Plant” includes any part of a plant; see section 132(1) of the Act.
f2: 1990 c. 16.
f3: S.I. 1991/762 (N.I. 7); as amended by S.I. 1996/1633 (N.I. 12).
f4: See Protocol 4 (on rules of origin) annexed to the EEA Agreement, as amended by the Decision of the EEA Joint Committee No. 6/94 amending Protocol 4 to the EEA Agreement (OJ No. L95, 14.4.94, p. 22).
f5: “Product licence” has the meaning assigned to it by section 7 of the Act.
f6: S.I. 1994/3144; as amended by S.I. 1998/3105.
f7: S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482 and 1999/566.