Long awaited European proposal on herbal harmonisation

The European Commission is to propose a specific registration procedure for herbal medicinal products with a long-standing traditional use.

In a recent statement the Commission claims that the aim of the new proposal is to improve quality checks and market surveillance. A clear and reliable regulatory environment for these products must be established that would benefit both patients and manufacturers, most of which are small- and medium sized enterprises (SMEs), the Commission continued.

Despite the fact that demand for herbal medicines is growing continuously across the European Union the rules governing the placing on the market and surveillance of these products differ from Member State to Member State. Such lack of harmonisation harms both the free movement of goods within the Union and has a negative impact on public health protection standards.

The Commission, finally some may say, is proposing a simplified registration system for traditional herbal medicinal products. The quality requirements are identical to those for all medicinal products. But instead of conducting new tests and trials on the safety and efficacy of the product, these can be assessed on the basis of the information gathered on its traditional use over a period of at least 30 years. Some of this use may have partially taken place outside the EU.

The proposal also provides for a new scientific committee of herbal medicine experts to be established within the London-based European Agency for the Evaluation of Medicinal Products.

For further details on the Proposal for a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products, COM(2002)1 visit the European Commission​ site.