Farmakovijilans Derneği

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013

The PRAC - one year of public health protection and promotion

The Pharmacovigilance Risk Assessment Committee (PRAC) has marked the successful completion of its first year of operation. The PRAC was established under the pharmacovigilance legislation that came into force in June 2012 to improve public health promotion and protection by strengthening the EU’s pharmacovigilance system. The Committee held its first meeting in July 2012.

PRAC welcomes Croatian Committee members

The PRAC also welcomed the full involvement of Croatia in its activities at its July 2013 meeting following the accession of Croatia to the European Union (EU) on 1 July 2013. Croatian delegates have been observers of the PRAC since it began its operations in July 2012.

Update on hydroxyethyl starch (HES)-containing solutions for infusions

Some marketing authorisation holders of hydroxyethyl starch (HES)-containing solutions for infusion have requested the PRAC to re-examine its June 2013 recommendation to suspend the marketing authorisations of these medicines. Because of this request, implementation of the PRAC’s recommendation has been put on hold.

In the meantime, some Member States have taken action to suspend or limit the marketing or use of these medicines in their territories. In accordance with EU legislation this type of action currently requires that a review procedure be carried out. Consequently, the United Kingdom has requested the PRAC to start this review procedure, which will run in parallel with the re-examination of the PRAC’s June 2013 recommendation.

New referral procedure on zolpidem-containing medicines started in July 2013

The PRAC started a review of zolpidem, a medicine used for short-term relief of insomnia. The review follows concerns that some patients may experience drowsiness and slower reactions the day after taking the medicine which could increase the risk of accidents during activities that require alertness, such as driving.

Other updates from the PRAC

The review of combined hormonal contraceptives continues. An expert meeting was convened in early July 2013 specifically to discuss this issue, and experts have presented their views to the PRAC. All information will be considered as part of the assessment. A recommendation from the PRAC is expected following its October 2013 meeting.

Please see new web page on combined hormonal contraceptives at the following link: Combined hormonal contraceptives.

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



Agenda - PRAC draft agenda of meeting 8-11 July 2013


Start of referral procedures

Hydroxyethyl starch-containing medicines

Article-107i procedure: Hydroxyethyl starch-containing medicines


Referral notification
Rationale for triggering
PRAC list of questions
PRAC List of questions to be addressed by the Stakeholders
Stakeholder\'s submission form
Timetable for the procedure
Annex I


Zolpidem-containing medicines

Article-31 referral: Zolpidem-containing medicines


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