Regulation (EU) 2019/6 establishes an EU-wide pharmacovigilance system led by the European Medicines Agency (EMA) in collaboration with Member States for all veterinary medicinal products authorised in at least one EU country. 

The entry into force of this Regulation on 28 January 2022 brought a change of approach to pharmacovigilance which is now based on a signal detection process. This system allows active and continuous monitoring of pharmacovigilance data in order to detect potential safety problems early. 
 
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