Herbal Medicines

Information

In general, products that are sold as medicines or having medicinal properties in Ireland must be licensed by the Irish Medicines Board (IMB), prior to being placed on the market in Ireland. Problems have arisen in relation to the licensing of traditional herbal medicines, particularly in relation to proving clinical efficacy and, as such, the IMB was asked by the Department of Health to develop a proposal for a national licensing system for traditional and alternative medicinal products, including herbal medicinal products.

The IMB has identified in the region of 2,246 herbal and traditional products being offered for sale in Ireland.

Rules

The IMB published a report called Herbal Medicines Project Final Report in January 2002. A Scientific Committee on Herbal Medicinal Products was established to help the IMB in drawing up its report.

The proposed licensing scheme aims to ensure that safe traditional medicinal products will continue to be available in the usual outlets and that consumers can be assured that the registered traditional medicinal products they buy:

  • Are produced to an appropriate quality standard
  • Are safe under the proposed conditions of use
  • Can be expected to act in accordance with an established tradition of use and
  • Are appropriately labelled.

Proposed EU Directive

A proposed EU Directive on Traditional Herbal Medicinal Products was published by the European Commission in January 2002. This proposal is being discussed by the European Parliament and the Council. The proposed IMB scheme is broadly in line with the proposed EU directive.

Where To Apply

Irish Medicines Board

Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland

Tel:+353 (0)1 676 4971
Fax:+353 (0)1 676 7836
Homepage: http://www.imb.ie
Email: imb@imb.ie


Department of Health

Hawkins House
Hawkins Street
Dublin 2
Ireland

Tel:+353 1 635 4000
Locall:1890 200 311
Fax:+353 1 635 4001
Homepage: http://www.dohc.ie

Page updated: 21 June 2010

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