Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2013

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08/03/2013

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2013

PRAC welcomes nominations of Committee members representing patients and healthcare professional organisations

The PRAC welcomed the appointment by the European Commission of one member and alternate each representing healthcare-professional and patient organisations.

Filip Babylon will represent healthcare-professional organisations and Albert van der Zeijden will represent patient organisations for a three-year period. Their alternates are Kirsten Myhr and Marco Greco, respectively.

The appointment was made by the European Commission following a public call for expression of interest and a consultation of the European Parliament.

The representatives of patients and healthcare-professional organisations will fully participate in the work of the PRAC from April 2013. Their role is to bring the views, concerns and experiences of patients and doctors to the PRAC’s scientific considerations, thus enriching its decision-making.

Review of Diane 35 and its generics continues – stakeholders’ contribution invited until 11 March 2013

The PRAC continued the assessment of all available data on Diane 35 and its generics, including any new information emerging from Member States. Stakeholders such as healthcare professionals, patient organisations and the general public are reminded that they have until 11 March 2013 to submit data relevant to the procedure to be considered during the review. Collecting stakeholders’ contributions is one of the new tools introduced by the new pharmacovigilance legislation. It allows the PRAC to actively engage stakeholders in the evaluation.

Four new referral procedures started in March 2013

The PRAC started four new referral procedures at its March 2013 meeting. This brings the number of referrals started by the PRAC to a total of 17 since the PRAC started its operations in July 2012.

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

The Agency publishes a new page following the PRAC meeting each month. The minutes of each PRAC meeting will be published during the week following the subsequent PRAC.

Agenda

 
Agenda - PRAC draft agenda of meeting 4-7 March 2013


Start of referral procedures

Kogenate Bayer and Helixate NexGen (octocog alfa)

Article-20 referral: Kogenate Bayer and Helixate NexGen (octocog alfa)

 

Referral notification
PRAC list of questions
Timetable for the procedure

 

Flupirtine-containing medicines

Article-107i procedure: Flupirtine-containing medicines

 

Referral notification
Rationale for triggering
PRAC list of questions to the marketing-authorisation holder
PRAC list of questions to stakeholders
Stakeholders' submission form
Timetable for the procedure
Annex I

 

Domperidone-containing medicines

Article-31 referral: Domperidone-containing medicines

 

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

 

Nicotinic acid and related substances

Article-31 referral: Nicotinic acid and related substances

 

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

Contact point:

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