Herbal Medicinal Products and Homoeopathics

Expert group "Herbal Medicinal Products and Homoeopathics"

Assessment, scientific and regulatory advice as well as all activities regarding the engagement of Austria in national and European bodies dealing with herbal medicinal products and homoeopathics are coordinated and performed within the Austrian Medicines and Medical Devices agency by this expert group. The individual experts are assigned to different organisational units.

Aims

Pooling of expertise in herbal medicinal products, homoeopathics and other products containing herbal ingredients as well as coordination of AGES experts working on these topics.



Core tasks

  • Regulatory processing and timeline-conform assessment of quality, safety and efficacy of all applications regarding herbal medicinal products and homoeopathics
  • Response to general scientific and regulatory questions related to herbal medicinal products and homoeopathics
  • Scientific and regulatory cooperation within scientific advices at national level and within European scientific advice procedures related to herbal medicinal products and homoeopathics
  • Contact persons for pharmaceutical industry, pharmacists, doctors, media and interested lay persons regarding questions about herbal medicinal products and homoeopathics.

 

Further duties

  • Representation of Austria in relevant bodies of the European Medicines Agency (Committee on Herbal Medicinal Products HMPC, Monographs and Lists working party MLWP, (see also statistics under http://www.basg.gv.at/news-center/statistiken/pflanzliche-arzneimittel), Quality drafting group of the HMPC)
  • Cooperation in working parties at the European Directorate for the Quality of Medicines & Healthcare, European Pharmacopoeia (e.g., TCM, extracts)
  • Cooperation in relevant bodies at national level (e.g., national pharmacopoeia, borderline issues)
  • Coordination with other organisational units of the AGES also dealing with herbal products (e.g., borderline products, food supplements, food analytics)

Support

FAQs:


Answers to frequently asked questions (FAQs) can be found here:


Herbal medicinal products: http://www.basg.gv.at/en/medicines/faq/herbal-medicinal-products


Homoeopathics: http://www.basg.gv.at/en/medicines/faq/homeopathic-medicinal-products


Documents for public consultation:


European Pharmacopoeia, Austrian Pharmacopoeia
Take the chance to comment on draft texts of the European Pharmacopoeia and the Austrian Pharmacopoeia:

Pharmeuropa Online: pharmeuropa.edqm.eu/TextsForComment/
Austrian Pharmacopoeia ÖAB , only in German language: http://www.basg.gv.at/labor/oesterreichisches-arzneibuch/
Please send your comments directly to the national pharmacopoeia authority, Ministry of health, section III, department 3 (BMG.SIII.Abt.3 @bmg.gv .at)

Committee on Herbal Medicinal Products (HMPC)
Publications of the HMPC are published for public consultation at the website of the European Medicines Agency:

www.ema.europa.eu, tab ‚Public consultations ‘

Comments should be sent directly to the secretariat of the HMPC (hmpc.secretariat @ema.europa .eu) using the template indicated in the respective documents.

Of course proposals for the improvement of already adopted documents may be submitted. We would be happy to forward them to the responsible contact person.

 

Kontakt

Coordinator of expert group:

Reinhard Länger

phone: +43 50555 36528

E-Mail: reinhard.laengeragesat

 

Deputy coordinator:

Astrid Obmann

phone: +43 50555 36522

E-Mail: astrid.obmannagesat

Created: 24.02.2014 | Page last modified: 22.03.2016

© Austrian Federal Office for Safety in Health Care
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