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

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30/11/2012

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

 

Referral notification
PRAC list of questions
Timetable for the procedure
Annex I

 

Diacerein

Article-31 referral: Diacerein

 

Referral notification
PRAC list of questions
Timetable for the procedure
Annex I

 

Hydroxyethyl starch solutions for infusion

Article-31 referral: Hydroxyethyl starch solutions for infusion

 

Referral notification
PRAC list of questions
Timetable for the procedure
Annex I

 

Short-acting beta-agonists

Article-31 referral: Short-acting beta-agonists

 

Referral notification
PRAC list of questions
Timetable for the procedure
Annex I

Related information

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu