The European Commission has proposed updates to its implementing regulation on pharmacovigilance requirements for human medicines marketed in the EU to introduce additional obligations for marketing authorization holders (MAHs), among other changes.
EU Consultation Deadline Looms For Pharmacovigilance Rules Update
Stakeholders have until 15 January to respond to a European Commission proposal that aims to harmonize pharmacovigilance activities by marketing authorization holders, national competent authorities and the European Medicines Agency.
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