The Coordination group for Mutual recognition and Decentralised procedures (CMDh) released an update of the CMDh Questions and Answers on Pharmacovigilance Legislation.
The Q&A 2 (“How should I submit a new RMP or an updated RMP to update my dossier?”) has been revised to stress that, for RMP updates, a clean and a tracked version (as a working document in word format) should be submitted to facilitate the assessment.
The updated Q&A document has been published on the CMDh website under “Questions & Answers”.
Refer to pharmacovigilance legislation from below link –
https://www.hma.eu/human-medicines/cmdh/questions-answers.html
