RMP template 2.0.1 draft - European Medicines Agency
An RMP should be assigned a new RMP version number and a date each time the RMP is updated and submitted for assessment (e.g. versions 0.1, 0.2, 0.3 etc. for an initial submission of an RMP; versions 1.1, 1.2, etc. and 2.1, 2.2 etc. for RMP updates post-authorisation). ... Signal detection, which is part of routine pharmacovigilance, will be an ...
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