How to Classify Borderline Products?

To assist applicants and competent authorities with product classification issues, the Committee on Herbal Medicinal Products (HMPC) has published a draft document on the use of information in herbal monographs and assessment reports for borderline cases. The document is open for comments until 1 May 2025.

Background Information

Active ingredients in herbal medicinal products (HMPs) are also found in other product categories such as food supplements, cosmetics or medical devices. The possibility of different categories of active substances/preparations of herbal origin can lead to different commercial decisions, e.g. where to consider time/resources for product development/application for a marketing authorisation/registration and the permitted indication (medicinal or health claim). However, there are products on the EU market containing herbal substances/preparations with significant differences in classification. Some similar or even identical products may appear under different statuses in different Member States, which could be confusing for patients/consumers and healthcare professionals.

Currently, there is no common EU guidance for applicants and national competent authorities on the requirements for classification of herbal substances/preparations as medicinal products. Importantly, it is the responsibility of the national competent authorities in the Member States to decide on the classification of medicinal products in their national territory. The draft document is therefore provided to assist Member States and applicants in borderline cases, so that products can be marketed under harmonised conditions in the EU and to ensure the protection of public health. EU herbal monographs and supporting assessment reports could serve as guidance in drawing the line between HMPs, medical devices, food supplements and cosmetics.

More information is available in the draft Reflection Paper on the use of information in EU herbal monographs and assessment reports for borderline issues published on the EMA website.