Herbal medicines: regulatory and scientific support

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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:

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:

Guidance documents

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

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:

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.

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