S. Mamatha*1, Dr. K.Umasankar2
1Krishna Teja Pharmacy College, Tirupati, A.P, India
2Head of the Department of Regulatory Affairs, Krishna Teja Pharmacy College, Tirupati.
A B S T R A C T
A European study on current regulatory legislation in the CIS Countries & Marketing authorization of herbal medicinal products in CIS countries was done for comparing the current regulations of both in CIS countries along with EU regulations. In this study includes not only marketing authorization but also the basic principles of the clinical trials required for registration procedures as well as some regulatory aspects of successful market access and post-marketing maintenance activities.
Keywords: Herbal medicinal products, Marketing Authorization, EU & CIS Regulatory, Legislation