herbal medicine and take into account the scientific conclusions of the HMPC. Information on the use and licensing of eleutherococcus root medicines in EU Member States should be ... the Committee’s conclusions, can be found under the tab ‘All documents’ on the Agency’s website:

March 9, 2016 - Monographs form the basis for the required individual medicinal product information such as the summary of product characteristics (SmPC) and the package leaflet. They are published together with other documents, including an assessment report containing reviews of all available data relevant for the medicinal use of the herbal substance or preparations.

January 1, 2015 - The European Medicines Agency's (EMA) scientific guidelines on herbal medicinal products help medicine developers prepare marketing-authorisation applications for human and veterinary medicines. Use the links below to find guidelines that are specifically related to herbal medicinal products: ... If you have comments on a document which is open for consultation, use the. ... public ...

March 13, 2025 - The HMPC conclusions on the use of these olive leaf medicines for water elimination are based on their 'traditional use'. This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).

The European legislation on medicinal ... plants. The objective of the legislation is to ensure the future existence of such products and to consider particular characteristics when assessing quality, efficacy, and safety...

national authorities responsible for medicinal products, which will assess the application for the herbal · medicine and take into account the scientific conclusions of the HMPC. Information on the use and licensing of ispaghula husk medicines in EU Member States should be ... Committee’s conclusions, can be found under the tab ‘All documents’ on the Agency’s website:

May 25, 2002 - This review was conceived at the Global Summit on Regulatory Sciences that took place in Beijing on September 2018 (GSRS2018) which is organized by Global Coalition for Regulatory Science Research (GCRSR) that consists of the global regulatory agencies from over ten countries including the European Union. This review summarizes a significant portion of discussions relating to a longitudinal comparison of the status for dietary supplements and herbal medicines among the different national jurisdictions and to the extent of how new tools and methodologies can improve the regulatory application.

April 9, 2025 - Background Adverse effects are common during cancer treatment and herbal medicinal products (HMPs) are one way to manage symptoms caused by conventional therapy. Objectives This assessment focused on comparing HMP indications listed in European Medicines Agency (EMA) monographs with findings ...

EU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any…

April 15, 2025 - This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of arnica flower. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ...

September 25, 2023 - HMPC prepares the Agency's opinions on herbal substances and preparations, along with information on recommended uses and safe conditions.

February 16, 2011 - Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries - Revision 1 · Reference Number: EMEA/HMPC/137093/2006 Rev. 1 Corr. ... Overview of comments received on HMPC draft procedure for calls for scientific data for use in HMPC assessment work (EMEA/HMPC/1004/2006) ... Procedure for the preparation of an entry to the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products'

March 15, 2018 - Purpose: A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies. Methods: A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected.

December 31, 2009 - 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 ...

March 19, 2018 - A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies. A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected.

August 14, 2024 - Download herbal medicines data table

The age range and use of herbal medicinal products, within this special population of patients, are frequently discussed by healthcare professionals. The purpose of this overview · is to provide a summary of the information from the monographs for ease of reference. The list pertains to the specific substances/preparations1 as mentioned in the European ...

the European Union (EU) herbal monographs. The list summarises the indications and any limitations of use in children as assessed by the Committee on Herbal Medicinal

The regulation and use of herbal medicines is a topic of debate due to concerns about their quality, safety, and efficacy. EU Directive 2004/24/EC on Herbal Medicinal Products was a significant step towards establishing a regulatory framework for ...

November 25, 2025 - This webinar is designed to provide participants with detailed knowledge and understanding of the relevant European Pharmacopoeia texts in the field of herbal medicinal products. It presents the general structure of the different general texts and general monographs and explains their relationship with the requirements given in the individual monographs. It was recorded on 27 April 2023 as part of an EU training course, in collaboration with the Heads of Medicinal Agencies (HMA) and the European Medicines Agency (EMA).