The directive of 25 October 2012 amending directive 2001/83/EC as regards pharmacovigilance was published in the Official Journal of the European Union on 29 October 2012. Member States shall apply those provisions before 28 October 2013.
The main objective of this directive is to establish an automatic procedure in order to guarantee that a safety issue is addressed in all the Member States where the medicine is marketed. This directive also aims at clarifying and strengthening the regular procedure and the EU emergency procedure to ensure a better coordination and a quick assessment in case of emergency.
In particular, this text requires more transparency from companies. The holder of the marketing authorization shall inform Member States' competent authorities and the European Medicines Agency of the reasons which led him to withdraw a medicine from the market, stop marketing a medicine, request the withdrawal of a marketing authorisation or refrain from asking for its renewal.