RAPS – Regulatory Updates: EU Herbal Medicine Ban to Face Legal Challenge – April 7, 2011

April 7, 2011 By


A ban on unregistered herbal medicines in the EU set to go into effect in May will face legal challenges from natural health advocates. Critics of the EU’s Traditional Herbal Medicinal Products Directive, originally passed in 2004, say it will be difficult to implement the law fairly and that it could actually expose more people to fraudulent and possibly unsafe herbal remedies. “We plan to challenge the directive first of all in the High Court in London, on the grounds that it is disproportionate, non-transparent and discriminatory. We then hope to have the case referred to the European Court of Justice in Luxembourg,” said Dr. Robert Verkerk, executive and scientific director of the Alliance for Natural Health.

Examples of remedies threatened following the expiry of the deadline include traditional European herbal cures using hawthorn and meadowsweet in addition to a swathe of herbs used in traditional Indian Ayurvedic, Chinese and Amazonian remedies. http://www.raps.org/newsroom/latest-news.aspx


The Traditional Herbal Medicinal Products Directive, 2004/24/EC, was established to provide a regulatory approval process for herbal medicines in the EU, and came into force on 30 April 2004. Under the regulation, all herbal medicinal products are required to obtain an authorisation to market within the EU.

Those products marketed before this legislation came into force can continue to market their product until 30 April 2011, under the transitional measures defined in the directive. Once this time limit has expired, all herbal medicinal products must have prior authorisation before they can be marketed in the EU.

Under the directive, a company needs to demonstrate the safety and efficacy of its herbal medicine through traditional use within the EU for at least 30 years, or 15 years within the EU and 30 years outside the EU.

The intended use of a herbal medicine will only be authorised on the basis of its traditional history and/or the recognised pharmacological properties of the herbal ingredients.


EMA Launches EU Clinical Trials Register

The European Medicines Agency (EMA) this week launched its EU Clinical Trials Register, an online database that gives the public access to information on interventional clinical trials for medicines authorized in the 27 EU Member States and Iceland, Liechtenstein and Norway. The register also allows the public to search for information on clinical trials authorized to be conducted outside the EU if they are part of a pediatric investigation plan. However, the register does not yet include summaries of clinical trial results.