1. Herbal medicines

1.2. Simplified registration procedure for Traditional herbal medicines

A special, simplified registration procedure (‘traditional-use registration’) is established for herbal medicines which fulfil all of the following criteria:

  • indications exclusively appropriate to traditional herbal medicines for use without the supervision of a medical practitioner;
  • exclusively administered with a specified strength and posology;
  • preparation is oral, external and/or inhalation;
  • a long tradition of medicinal use;
  • sufficient safety data in the specified conditions of use and plausible efficacy;

The simplified procedure allows the registration of a Traditional herbal medicine:

  • without requiring documents on tests and trials on safety and efficacy, if the efficacy is plausible on the basis of its long-standing use and experience as testified by bibliographic or expert evidence;
  • if the safety is substantiated by a bibliographic review of safety data together with an expert report;
  • with bibliographical or expert evidence that the medicine, or a corresponding product has been in medicinal use for at least 30 years, including at least 15 years in the Union preceding the date of the application (Article 16c(1)(c) of Directive 2001/83/EC)
  • is intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment and therefore has to be a non-prescription medicine;
  • fulfils the same requirements as applications for a marketing authorisation with regards to the manufacturing and quality. Results of pharmaceutical (physico-chemical, biological or microbiological) tests must be submitted.