Pharmacy Daily | EMA PI consultation

THE European Medicines Agency has launched a public consultation on changes to product information, due to the new pharmacovigilance legislation (PD 03 Jul). The new laws require the addition of information to product information and consumer medicines information, including a statement and a black symbol for medicines that are under additional monitoring for safety issues. The changes also require a further statement encouraging healthcare professionals and patients to report suspected side effects from the medicine to their national reporting system, and will apply to all human medicines marketed in the EU. The consultation is open until 17 August, with feedback sought on the location of the symbol and the wording of the explanatory statements and standardised text. MEANWHILE the EMA has also named Emer Cooke as its Head of International and European Cooperation. Cooke is a pharmacist with an MBA and has been working at the agency since 2002.

---

The above article was sent to subscribers in Pharmacy Daily's issue from 18 Jul 12
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 18 Jul 12