The Herbal Medicines Advisory Committee Order 2005

• Citation: S.I. 2005/2791
• Sections: 2

Section 1 Citation, commencement and interpretation

(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 ;

“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 ;

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

“marketing authorization” means—

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

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

Section 2 Herbal Medicines Advisory Committee

There shall be established a committee to be called the Herbal Medicines Advisory Committee for the purposes of giving advice—

(a) with respect to the safety, quality and efficacy, in relation to human use, of herbal medicinal products, other than any product—

(i) in respect of which a marketing authorization, a product licence or a certificate of registration has been granted, or

(ii) which is the subject of an application for such an authorization, licence or certificate;

(b) with respect to the safety, quality and efficacy, in relation to human use, of any herbal medicinal product—

(i) in respect of which a marketing authorization, a product licence or a certificate of registration has been granted, or

(ii) which is the subject of an application for such an authorization, licence or certificate,

where Health Ministers or the licensing authority request such advice or provide the committee with information relating to that product; and

(c) in relation to the sale, supply, manufacture or assembly of medicinal products under section 12 of the Act.