SQA Regulatory Surveillance Summary 3 | Monthly Update 2021
SQA
APRIL 30, 2021
In addition, considering the fact that one marketing authorization application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorization application is submitted under an abridged procedure (e.g., Under Article 82(1) of Regulation (EC) No.
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