The Herbal Medicines Advisory Committee Order 2005

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Herbal Medicines Advisory Committee Order 2005 and shall come into force on 30th October 2005.

(2) In this Order—

“certificate of registration” means a certificate of registration granted by the licensing authority under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(1);

“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(2);

“herbal medicinal product” has the meaning given by Article 1(30) of the 2001 Directive;

“marketing authorization” means—

(a)

a marketing authorization granted by the licensing authority under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(3), or

(b)

a marketing authorization granted by the European Commission under Council Regulation (EEC) No 2309/93(4) or under Regulation (EC) No. 726/2004(5).

(1)

S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 542, 2003/625 and 2321, and 2004/666.

(2)

OJ No. L311, 28.11.2001, p.67. Directive 2001/83/EC has been amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (OJ No. L33, 8.2.2003, p.30), Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ No. L159, 27.6.2003, p.46), Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ No. L136, 30.4.2004, p.85) and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ No. L136, 30.4.2004, p.34).

(3)

S.I. 1994/3144; relevant amending instruments are S.I. 2001/795 and 2002/236.

(4)

Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, OJ No. L214, 24.08.93, p.1.

(5)

Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ No. L136, 30.4.2004, p.1.