Herbal Medicines
Find providers of services for the authorisation of herbal medicines.
The list does not claim to be complete and no guarantee can be given for the correctness and up-to-dateness of the information provided. Furthermore, please note that this list does not have any recommendatory character.
If you are a provider of services in this area, you have the possibility to register free of charge in this directory.
- New development of new herbal products
- Development of the optimal regulatory strategy
- Comprehensive assistance with the full marketing authorization or, respectively, registration of herbal medicinal products (THMP or WEU)
- Preparation of and assistance with meetings with drug authorities
- Gap analyses of existing registration documentation
- Drawing up and/or updating of the Common Technical Document (CTD)
- Proof of tradition for Traditional Herbal Medicinal Products (THMP)
- Expert statements
- Compilation of PSURs for herbal medicinal products
- Development and marketing authorisation of herbal medicinal products – well-established use (WEU), regular marketing authorisations and simplified traditional registrations
- Project planning and coordination
- Regulatory assessments and strategy
- Licensing out, dossiers and registrations
- Marketing authorisation research, providing evidence of traditional use, eCTD preparation and maintenance
- Support with authorisation and registration procedures in all EU countries