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Agenzia Italiana del Farmaco
Submission of variation to implement PRAC recommendations following the evaluation of a signal management procedure - Submission of variation to implement PRAC recommendations following the evaluation of a signal management procedure
Submission of variation to implement PRAC recommendations following the evaluation of a signal management procedure
MAHs have a legal obligation to comply with the conclusion and recommendations arising following the assessment of a signal as per Art. 107h of Directive 2001/83/EC, Art. 28a of Regulation (EC) No 726/2004 and Chapter III Commission Implementing Regulation (EU) No 520/2012.
The following document is intended to clarify the timeline for submission of variation to implement PRAC recommendations, if not specified in the PRAC recommendation.
Published on: 14 October 2021
