Transcription of PRAC recommendations on signals
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PRAC recommendations on signals
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 25 October 20211 EMA/PRAC/540066/2021 Pharmacovigilance Risk Assessment Committee (PRAC) prac recommendations on signals Adopted at the 27-30 September 2021 PRAC meeting This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 27-30 September 2021 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]2 reference numbers).
Sep 30, 2021 · PRAC recommendations on signals EMA/PRAC/540066/2021 Page 2/10 . The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified. For procedural aspects related to the handling of PRAC recommendations on signals (e.g. …
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