Herbal medicines: regulatory and scientific support

Companies seeking market access for traditional herbal medicines in European Union (EU) Member States need to follow national procedures. However, applicants can request scientific support and advice from the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA). National competent authorities of Member States can consult the HMPC on scientific and regulatory aspects of applications.

Support and advice for applicants

Companies applying the first time for a registration of their product are advised to refer to the Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products and to scientific guidelines.

They should seek scientific advice at the national competent authorities of EU Member States where they are seeking market access via traditional use registration or well-established use authorisation.

In some cases they can also request scientific support from the HMPC or general scientific advice from EMA:

• Guidance for companies seeking scientific support and advice on traditional herbal medicinal products
• Template for submission of a request for scientific support and advice on a traditional herbal medicinal product

Before submitting a request, applicants should check the questions and answers section to see if their query has been addressed already.

Advice for national competent authorities

National competent authorities can submit questions for the HMPC to discuss:

• Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC

Guidance documents

These statements have been published by the HMPC to clarify specific positions regarding regulatory aspects of herbal medicines:

• Patient Leaflet template concerning advice on the preparation of herbal teas as (traditional) herbal medicinal products by end-users
• Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products
• Public statement on CPMP List of Herbal Drugs with serious risks, dated 1992
• HMPC statement on environmental risk assessment of herbal medicinal products

The following documents adopted by the HMPC are relevant for the evaluation by national competent authorities of Cannabis-derived medicinal products: 

• Compilation of terms and definitions for Cannabis-derived medicinal products

Referrals

Standard referral procedures applicable for all medicinal products, including herbal medicines, are not primarily addressed to the HMPC.

However, Member States may refer traditional herbal medicinal products to the HMPC in two specific situations:

• Adequacy of evidence of the long standing use - HMPC establishes whether evidence of the longstanding use of a corresponding product is acceptable ( Article 16c (1)(c) of Directive 2001/83/EC );
• Traditional use less than 15 years - HMPC considers whether a simplified registration is possible if the product has been used in the EU for less than 15 years ( Article 16c (4) of Directive 2001/83/EC ).

These referrals to the HMPC lead to an opinion, but not to a binding European Union procedure.

In some cases, Article 16c(4) referrals may also lead to a monograph which Member States shall take into account.

• Guidance on documentation to be provided by Member States and applicants/MAHs in support of a simplified registration referral under articles 16c(1)c and 16c(4)