SQA Regulatory Surveillance Summary 3 | Monthly Update 2021
SQA
APRIL 30, 2021
generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. Under Article 82(1) of Regulation (EC) No. European Medicines Agency (EMA) – Biologics.
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