Page History

Answer:

The certification The Certification procedure is also applicable applies to herbal drugs and herbal drug preparations covered by a Ph. Eur. monograph. The information to be submitted for applying for a certificate of suitability is described in the document "Content of the dossier for herbal drugs and herbal drug preparations quality evaluation " (available on our internet site) (PA/PH/CEP (02) 6 1R), which should be read in conjunction with the Note for guidance current versions of the EMA Guideline on specifications: test procedures and acceptance criteria for herbal drugssubstances, herbal drug preparations and herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2820/00 ) Rev 1 and the Note for guidance Rev. 2) and the EMA Guideline on quality of herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2819/00) Rev 1, and Resolution AP-CSP (93) 5 as amended : certification of suitability to the monographs of the European Pharmacopoeia. 
Certificates of suitability may be granted for herbal drug and herbal drug preparation in combination or separately. However, it is reminded that when applying for an herbal drug preparation the documentation provided should include that related to the specific requirements for the corresponding herbal drug

For more information, see How to read a CEP (PA/PH/CEP (15) 31).