The legislation requires the addition of information to the summary of product characteristics, which is targeted at healthcare professionals, and to the package leaflet, which is targeted at patients and consumers. This information includes:
– a statement and a black symbol for medicines that are under additional monitoring for safety issues;
– a statement encouraging healthcare professionals and patients to report suspected side effects from the medicine to their national reporting system.
The changes will apply to all centrally authorised human medicines, as well as human medicines authorised through the mutual-recognition or decentralised procedures and human medicines subject to referrals to the Agency.
During the preparation for this public consultation, the Agency consulted European Union Member States, pharmaceutical industry associations and patient, consumer and healthcare-professional organisations on the new statements included in the draft revision of the template.
The consultation is open until 17 August 2012.