The Herbal Medicines Advisory Committee Order 2005

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(1). 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.

(1)

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.