Herbal medicinal products

The Committee on Herbal Medicinal Products (HMPC) issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions, on behalf of the European Medicines Agency (EMA). This gives companies and national competent authorities a clear reference point when preparing or assessing an application for marketing authorisation or registration of herbal medicinal products in European Union (EU) Member States.

In this section

Bringing herbal medicinal products to market within the EU

• Scientific guidelines
• Regulatory and scientific support
• Questions and answers

Establishing EU standards for national procedures

• EU monographs and list entries
• Procedures for monograph and list establishment (including calls for scientific data and public consultations)

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.

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)	No clinical tests and trials on safety and efficacy are required as long as sufficient safety data and plausible efficacy are demonstrated Involves assessment of mostly bibliographic safety and efficacy data Must have been used for at least 30 years, including at least 15 years within the EU Are intended to be used without the supervision of a medical practitioner and are not administered by injection	National competent authority of a Member State for national, mutual recognition and decentralised procedures
Well-established use marketing authorisation (Article 10a of Directive 2001/83/EC)	Scientific literature establishing that the active substances of the medicinal products have been in well-established medicinal use within the EU for at least ten years, with recognised efficacy and an acceptable level of safety Involves assessment of mostly bibliographic safety and efficacy data	National competent authority of a Member State for national, mutual recognition and decentralised procedures EMA if centralised procedure applies
Stand-alone or mixed application (Article 8(3) of Directive 2001/83/EC)	Safety and efficacy data from the company's own development or a combination of own studies and bibliographic data	National competent authority of a Member State for national, mutual recognition and decentralised procedures EMA if centralised procedure applies

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.

Establishing EU standards for national procedures

To support EU Member States, the HMPC focuses on two main tasks:

• establishing EU monographs covering the therapeutic uses and safe conditions of well-established and/or traditional use for herbal substances and preparations;

• drafting a EU list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.

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.

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.

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:

• Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States