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

(1)

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

(2)

The prohibition imposed by paragraph (1) above shall not apply to the sale, supply or importation of the medicinal products referred to where the sale or supply is to, or, in the case of importation, the importation is made 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 to the importation of the medicinal products referred to—

(a)

from a member State of the European Community, or

(b)

if the products originated in an EEA State within the meaning of Article 9 of, and Protocol 4 to, the Agreement on the European Economic Area signed at Oporto on 2nd May 1992^f4, as adjusted by the Protocol signed at Brussels on 17th March 1993^f5, from an EEA State other than a member State.

(4)

The prohibition imposed by paragraph (1) above shall not apply to the sale, supply or importation of the medicinal products referred to where the products are the subject of a product licence^f6, a marketing authorization within the meaning of regulation 1(4)(a) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994^f7 or a certificate of registration within the meaning of regulation 1(2) of the Medicines (Homoeopathic Products for Human Use) Regulations 1994^f8.

Annotations

Footnotes

f1: “Plant” includes any part of a plant; see section 132(1).
f2: 1990 c. 16.
f3: S.I. 1991/762 (N.I. 7) as amended by S.I. 1996/1633 (N.I. 12).
f4: OJ No. L1, 3.1.94, p.3
f5: OJ No. L1, 3.1.94, p.572.
f6: “Product licence” has the meaning assigned to it by section 7 of the Act; see section 132(1) of the Act.
f7: S.I. 1994/3144 as amended by S.I. 1998/3105.
f8: S.I. 1994/105 as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/3105 and 1999/566.