The European Medicines Agency has released for public consultation the following draft consultations concerning herbal medicines:
- Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3
- Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3
The first addresses specifications, i.e. those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life, while the second one covers the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use.
Comments should be provided using this template and sent to hmpc.secretariat@ema.europa.eu by 30 November 2018.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
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