Wednesday , 21 October 2020

Guidelines for Submission of Post Approval Variation Medicine Applications

B. Ranganayakulu*, Syed Irshad Ahamed1, S. Mohammed Yusuf2, Dr. A.Srikanth3
*,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.

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