Herbal Medicinal Products - Major developments

April 2011
Paola Testori Coggi, Director-General of DG Health & Consumers, explains the Herbals Directive
On 30 April 2011, the period granted for herbal medicines to be registered will expire. This deadline rings to an end a seven year period allowd by a Directive adopted in 2004. The Director General of the European Commission for Health and Consumers explains explains the situation in order to address certain concerns expressed by citizens in the European Union.

Background information: Some plants contain substances that may be used to treat diseases. Medicinal products that are made from these substances are known as "Herbal Medicinal Products". Even though they are natural, a number of these products may be dangerous for patients. This is why they are covered by pharmaceutical legislation, which aims to protect public health by ensuring the safety, efficacy and quality of medicinal products.

However, traditional herbal medicinal products have particular characteristics, notably their long tradition of use. To take account of this, the EU adopted in 2004 the Herbal Directive (Directive 2004/24/EC)pdf introducing a lighter, simpler and less costly registration procedure for them, while providing the necessary guarantees of quality, safety and efficacy. It gave an exceptionally long transitional period of 7 years to register traditional herbal medicinal products that were already on the market on the date of entry into force of the Directive. This 7 years transitional period ends on 30 April 2011.

The Herbal Directive regulates traditional herbal medicinal products through a simple and light registration procedure. It does not apply to alternative therapies and does not ban any specific substances, practitioners, books or plants.

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List of herbals use in traditional herbal medicines:

Commission decision of 25 March 2010 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 26 March 2010. This decision includes ‘Mentha x piperita L.’ in the list of herbal substances. 
The text of the decision is available here.
pdf

Commission decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 19 January 2010. This decision includes ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ in the list of herbal substances. 
The text of the decision is available herepdf

Commission decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products Commission Decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 16 January 2010. This decision includes ‘Calendula officinalis (L.)’ and ‘Pimpinella anisum (L.)’ in the list of herbal substances.
The text of the decision is available here.pdf

Communication from the Commission to the Council and the European Parliament concerning the Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products. COM(2008) 584 finalpdf

The document prepared on the basis of Article 16i of Directive 2001/83/EC has been adopted and transmitted to the Council and the European Parliament.

On 30 May 2007, the Commission launched a consultation on a draft report on the experience acquired as a result of the application of the specific provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products, as required under Article 16i of Directive 2001/83/EC.

Comments on the document were invited to be submitted until 10 August 2007.

The draft report can be found herepdf(57 KB)

A summary of responses to the public consultation is available herepdf(33 KB)