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Post Approval Life Cycle Management of Variations for Generic Drugs in BrazilBy Achin jain, Neenu Ganesh
Abstract: Changes or variations in respect of any information concerning the registered or approved drug products, including information on the formulation of the registered/listed goods or other aspects of their manufacture, and the labeling of the goods, shall forthwith be notified to the agency and the change or variation shall not be implemented until approved by the agency. Changes occurs to have business continuity, if any quality problem arises, to maintain …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 3, 2017 · pp. 37–42 Read article →