|Bringing herbal medicinal products to
market within the EU
|Establishing EU standards
for national procedures
Companies seeking to bring herbal medicinal products to the market in EU Member States should follow the national procedures overseen by national competent authorities.
There are three main regulatory pathways for bringing a herbal medicinal product to market in EU Member States:
|Regulatory pathway||Main requirements on safety and efficacy||Where to apply|
Traditional use registration
(Article 16a(1) of Directive 2001/83/EC)
Well-established use marketing authorisation
(Article 10a of Directive 2001/83/EC)
|Stand-alone or mixed application (Article 8(3) of Directive 2001/83/EC)||
For further information, see:
Regardless of partially simplified requirements on safety and efficacy data, a full quality dossier is required for all herbal medicinal products (see section 'quality' in scientific guidelines) as well as other fundamental principles that are applicable to all medicinal products including good manufacturing practice, pharmacovigilance and requirements on packaging and labelling.
To support EU Member States, the HMPC focuses on two main tasks:
EU herbal monographs should not be confused with monographs of the European Pharmacopoeia which cover the quality requirements for a wide range of substances, including herbal substances and preparations.
However, general quality matters are also addressed in scientific guidelines issued by the HMPC.
Companies seeking a traditional use registration for their product can use EU monographs and list entries as reference material for their application.
If applicants can demonstrate that their traditional medicinal product complies with the EU list, no further evidence of the safe and traditional use is required.
The monographs can also be used by companies seeking a well-established use marketing authorisation.
A simplified registration procedure for traditional herbal medicinal products was introduced in 2004 through Directive 2004/24/EC (the Herbal Directive), which amends Directive 2001/83/EC. It aims to protect public health and secure the free movement of herbal medicinal products within the EU.
While most individual herbal medicinal products continue to be licensed nationally by Member States, the process for licensing and information on herbal substances and preparations is increasingly harmonised across the EU.
One impact of the Herbal Directive is that all Member States can refer to one unique set of information on a herbal substance or herbal preparation when evaluating marketing applications for herbal medicinal products from companies.
This information is provided in EU herbal monographs or EU list entries.
A brief description of the procedure is available on the European Commission's website under point 3.4 of the Notice to Applicants Volume 2A - Procedures for marketing authorisation, Chapter 1 - Marketing Authorisation. For further information, please refer to the relevant national competent authority.
As an outcome of the 'Action plan for herbal medicines 2010-2011', EMA publishes regular reports on the uptake of the traditional use registration scheme in the EU Member States: