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(3);

“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(4);

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

“marketing authorization” means—

Herbal Medicines Advisory Committee

2.  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.

Explanatory Note

(This note is not part of the Order)

This Order establishes the Herbal Medicines Advisory Committee to advise on any issue relating to the safety, quality and efficacy, in relation to human use, of unlicensed herbal medicinal products or herbal medicinal products eligible for registration under the simplified traditional use registration procedure established by Chapter 2a of Title III of Directive 2001/83/EC as inserted by Directive 2004/24/EC(8). The committee may also advise on the safety, quality and efficacy, in relation to human use, of a herbal medicinal product which is already licensed with a marketing authorization, product licence or certificate of registration or where an application for an authorization, licence or certificate has been made where the Health Ministers or the licensing authority request such advice or provide the committee with information relating to that product.

In addition, the Herbal Medicines Advisory Committee is established to advise on medicinal products sold, supplied, manufactured or assembled under section 12 of the Act. Section 12 of the Act provides an exemption from the requirement to have a product licence, a manufacturer’s licence or a wholesale dealer’s licence for herbal remedies which are sold or supplied following a consultation, and for remedies which are not industrially produced and are sold or supplied without any written recommendations for the use of the remedy.

A full regulatory impact assessment has not been produced for this instrument as it has no impact on the costs of business.