Regulatory pathways for bringing herbal medicinal products to market in EU Member States

Bringing herbal medicinal products to market within the EU

Companies seeking to bring herbal medicinal products to the market in EU Member States should follow the national procedures overseen by national competent authorities(1).

There are three main regulatory pathways for bringing a herbal medicinal product to market in EU Member States:

For further information, see:

• Rules governing medicinal products in the European Union, Notice to applicants, Volume 2A, Chapter 1 on marketing authorisation and Chapter 2 on mutual recognition
• CMDh Q&A Traditional herbal medicinal products (CMDh/287/2013)

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.

Legal framework

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.

(1) The national competent authorities are primarily responsible for the authorisation of medicines available in the EU

List of national competent authorities in the EEA