Guidelines for Submission of Post Approval Variation Medicine Applications

B. Ranganayakulu*, Syed Irshad Ahamed¹, S. Mohammed Yusuf², Dr. A.Srikanth^3
*,2 Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India
¹Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India
³ Assistant Professor, Vasavi Institute of Pharmaceutical Sciences, Kadapa, A.P., India

A B S T R A C T
This guideline is applicable only to active pharmaceutical ingredients (APIs) and excipients manufactured by chemical synthesis or semi-synthetic processes and medicines containing such APIs and excipients for finished pharmaceutical products that are registered by the Authority for sale in Ethiopia. Variations to a biological API and/or biological excipient or to biological finished pharmaceutical products are assessed as major changes.