Committee for Herbal Medicinal Products (HMPC): 19-20 September 2016
EventHerbal
Date
- Monday, 19 September 2016, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency's opinions on questions relating to herbal medicines.
Documents
Minutes of the HMPC 19-20 September 2016 meeting
AdoptedReference Number: EMA/HMPC/790627/2016
English (EN) (228.82 KB - PDF)
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Agenda - HMPC agenda of the 19-20 September 2016 meeting
Reference Number: EMA/HMPC/616784/2016Summary:
Committee on Herbal Medicinal Products (HMPC) - Agenda for the meeting on 19-20 September 2016
English (EN) (162.57 KB - PDF)
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HMPC meeting report on European Union herbal monographs, guidelines and other activities - 19 - 20 September 2016
English (EN) (90.45 KB - PDF)
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Related documents
- Concept paper for public consultation.
- Deadline for comments 30/11/2016.
Concept paper on the revision of the 'Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for sim...
Draft: consultation closedConsultation dates:
to Reference Number: EMA/HMPC/353983/2016Summary:
In 2006, the 'Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration' was published. The purpose of the guideline was to harmonize the minimum requirements for non-clinical data for well-established herbal medicinal products in bibliographical applications for marketing authorisations and to provide guidance which non-clinical safety aspects should be addressed in the expert report for the simplified registration of traditional herbal medicinal products and which additional non-clinical safety tests might be necessary to prove safety. The guideline has now been available for approximately 10 years and a considerable practical experience has been gathered during the use of this Guideline in national and European applications and for the preparation of more than 150 monographs.
English (EN) (86.79 KB - PDF)
First published: Last updated: