EN PL

EMA: mplementation plan for the introduction of the new pharmacovigilance legislation requirements into the product information of centrally approved medicinal products.

21.03.2013
As part of the implementation of the European Union (EU) pharmacovigilance legislation, the European Medicines Agency has updated the product-information template to allow easy identification of human medicines that are subject to additional monitoring and to encourage adverse-reaction reporting for all medicines.