Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 November 2012

30 November 2012

Four new safety referrals evaluated as impact of new legislation kicks in

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) held its fifth meeting from 26 to 29 November 2012.

At the meeting, the PRAC started a review of four medicines that are nationally authorised in European Union (EU) Member States. The Committee also evaluated evidence for new safety signals from EU reporting systems, assessed updated risk-management plans for certain medicines and discussed a number of periodic safety update reports.

Since the PRAC's first meeting in July 2012, fresh procedures have started under the new pharmacovigilance legislation. The increasing number of reviews for the PRAC, triggered by EU Member States, indicates that the legislation is working effectively and underlines that Member States view the PRAC as the effective mechanism for assessing all aspects of risk management for human medicines.

For an overview of all information available following the meeting of the PRAC, see the table below.

The minutes from the fourth PRAC meeting, which took place from 29-31 October 2012, will be published early next week.

Agenda

Agenda - PRAC draft agenda of meeting 26-29 November 2012

Start of referral procedures

Almitrine
Article-31 referral: Almitrine   Almitrine Article-31 referral - Notification Almitrine Article-31 referral - PRAC list of questions Almitrine Article-31 referral - Timetable for the procedure Almitrine Article-31 referral - Annex I

 

Diacerein
Article-31 referral: Diacerein   Diacerein Article-31 referral - Notification Diacerein Article-31 referral - PRAC list of questions Diacerein Article-31 referral - Timetable for the procedure Diacerein Article-31 referral - Annex I

 

Hydroxyethyl starch solutions for infusion
Article-31 referral: Hydroxyethyl starch solutions for infusion   Hydroxyethyl starch Article-31 referral - Notification Hydroxyethyl starch Article-31 referral - PRAC list of questions Hydroxyethyl starch Article-31 referral - Timetable for the procedure Hydroxyethyl starch Article-31 referral - Annex I

 

Short-acting beta-agonists
Article-31 referral: Short-acting beta-agonists   Short-acting beta-agonists Article-31 referral - Notification Short-acting beta-agonists Article-31 referral - PRAC list of questions Short-acting beta-agonists Article-31 referral - Timetable for the procedure Short-acting beta-agonists Article-31 referral - Annex I