Amendments to EMA pharmacovigilance legislation: new notification requirements

The European Medicines Agency has announced that marketing-authorization holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the Agency, in accordance with the amendments to the 2010 pharmacovigilance legislation of the European Union:

• temporary or permanent marketing cessation or suspension of marketing of a medicine;
• withdrawal of a medicine from the market;
• a request to withdraw a marketing authorization;
• the intention not to apply for the renewal of a marketing authorization.

These amendments were adopted in October 2012. The new provisions apply to centrally authorized medicines from June 5, 2013, and will apply to nationally authorized medicines from October 28, 2013.