European Directive on Traditional Herbal Medicinal Products

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European Directive on Traditional Herbal Medicinal Products (Directive 2004/24/EC) is a European Union (EU) legislation aimed at regulating the sale and use of traditional herbal medicinal products within the EU. This directive was adopted on 31 March 2004, as an amendment to Directive 2001/83/EC on the Community code relating to medicinal products for human use. It seeks to ensure that traditional herbal medicines available on the market are safe and meet certain quality standards.

Background

The directive acknowledges the long-standing traditions of herbal medicines in Europe and the need for a regulatory framework that allows consumers access to these products while ensuring their safety, efficacy, and quality. Before the implementation of this directive, the regulation of herbal medicines varied significantly across EU member states, leading to market disparities and concerns over the safety and quality of these products.

Scope and Requirements

The directive covers traditional herbal medicinal products that are used, particularly in the area of self-medication, without the supervision of a medical practitioner. To be eligible for authorization under this directive, a product must meet the following criteria:

• It must be used within the EU for at least 30 years, including at least 15 years within the EU.
• It should be intended and designed for use without the supervision of a medical practitioner and should not be administered by injection.
• The product must be exclusively composed of one or more herbal substances or herbal preparations.

Simplified Registration Procedure

One of the key features of the directive is the introduction of a simplified registration procedure for traditional herbal medicinal products. This procedure allows for the registration of products based on their traditional use rather than requiring detailed pharmacological and clinical trials. However, applicants must still provide evidence of the product's safety and traditional use, including bibliographical or expert evidence.

Traditional Herbal Medicinal Products Committee

The directive also led to the establishment of the Traditional Herbal Medicinal Products Committee (THMP Committee) within the European Medicines Agency (EMA). This committee is responsible for assessing applications for the simplified registration of traditional herbal medicinal products and advising on matters related to herbal medicines.

Impact

Since its implementation, the directive has had a significant impact on the herbal medicine market in the EU. It has led to the withdrawal of some products that could not meet the safety and quality standards set out in the directive. However, it has also provided a clear regulatory pathway for the approval of traditional herbal medicinal products, ensuring that consumers have access to safe and high-quality herbal medicines.

Controversies and Criticisms

The directive has faced criticism from some herbal practitioners and manufacturers, who argue that the regulatory requirements are too stringent and may limit the availability of traditional herbal medicines. There are also concerns about the impact on the diversity of herbal products available in the market and the preservation of traditional herbal knowledge.

Conclusion

The European Directive on Traditional Herbal Medicinal Products represents a significant step towards harmonizing the regulation of herbal medicines across the EU. By ensuring that these products meet specific safety and quality standards, the directive aims to protect consumers while allowing them access to traditional herbal remedies.