GRS Blog

Overview and update on EU directive 2004/24/EC: Traditional herbal medicines (peer reviewed article)

15/5/2011

Abstract: By now, all regulatory affairs professionals will be fully aware of the European Directive on Traditional Herbal Medicinal Products (2004/24/EC), with some professionals being directly involved in the registration process.  Many herbal companies, however, are new to what they believe is stringent legislation.  These companies struggle to comply with their current staffing levels and with limited or no experience in regulatory affairs.  As the April 2011 deadline draws ever closer, signalling the end of the transitional period for traditional herbal remedies to obtain registration, this article will attempt to identify what, if any, updates there have been since Regulatory Rapporteur featured traditional herbal medicines back in 2008.  It also includes feedback from companies about the impact that the European Directive on Traditional Herbal Medicinal Products (2004/24/EC) has had on their businesses, along with their predictions for the future of the industry.  To provide a balanced viewpoint, the MHRA was consulted via a telephone briefing, the results of which are recorded in this article.

Please click on the traditional herbal medicines link to view the full version of this article.