EMA Opens Consultation on Product Information Changes

Posted 17 July 2012 | By Louise ZornozaRegLink

The European Medicines Agency (EMA) has opened a consultation on the information changes to the summary of product characteristics (SmPC) and package leaflets mandated by the new European pharmacovigilance law.  

The legislation requires the addition of information to the SmPC, which is aimed at healthcare professionals, and to the package leaflet, which is aimed at patients and consumers. This information is to include:

  • a statement and a black symbol for medicines that are under additional monitoring for safety issues; and
  • a statement encouraging healthcare professionals and patients to report suspected side effects from the medicine to their national reporting system.

The proposed changes apply to all products whether approved through the centralized, mutual recognition or decentralized procedures.  During the preparation for this public consultation, the EMA consulted European Union Member States, pharmaceutical industry associations and patient, consumer and healthcare-professional organizations on the new statements included in the draft revision of the template. The comment period closes on 17 August.

Read more:

EMA - Quality Review of Documents (QRD) human product information annotated template: revision of the product information

More Breaking News from RegLink



Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe