On 28 September 2011, the EMA published a document entitled "Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal Products".
Compared to the previous, only small changes have been made. Not only new or revised guidelines have been taken into account but also the revised "Herbal Drugs" Monograph from the European Pharmacopoeia as well as new requirements regarding impurities.
The structure of the guideline itself hasn't changed.
Please see the revised "Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products" for further information.
PS: The monograph "Water for Preparation of Extracts" (04/2012:2249) has now been included in version 7.4 of the European Pharmacopoeia.
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)