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 professionals and patient organisations. Filip Babylon will represent healthcare professionals’ organisations and Albert van der Zeijden will represent patients’ 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 interests 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, patients’ 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’ contribution is one of the new tools introduced by the 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.


Start of referral procedures

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


  • Flupirtine-containing medicines: Article 107i referral: Flupirtine-containing medicines


  • Domperidone-containing medicines: Article 31 referral: Domperidone-containing medicines


  • Nicotinic acid and related substances: Article 31 referral: Nicotinic acid and related substances


Posted on the EMA website on 8 March 2013