The impact of new pharmacovigilance rules on marketing authorisation holders of medicinal products

26 September 2013

Bird & Bird, The Hague

What you really need to know about the new pharmacovigilance legislation

As a marketing authorization holder of medicinal products you are well aware of the importance of pharmacovigilance, defined by the WHO as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

The European pharmacovigilance legislation has recently been revised substantially. Regulation (EC) No 1235/2010 entered into force in July 2012, amending Regulation (EC) No 726/2004. Directive 2010/84/EU has now been implemented in the Dutch Medicines Act.

This was triggered by problems with the cooperation between the Member States, and by incidents such as Lipobay, Vioxx and of course the Mediator case.

In general, the new legislation aims to increase transparency about the safety of medicinal products. Some medicinal products will be put under additional monitoring which will be transparent for anyone. Besides, the competent authorities will be given clearer roles and responsibilities and also more effective instruments for enforcement. Efficacy and safety studies may be imposed even after marketing authorization. The new pharmacovigilance rules will result in more coordination and cooperation between the Member States, the Commission and the European Medicines Agency (EMA). Further, a new committee is introduced: the Pharmacovigilance Risk Assessment Committee (PRAC). Product liability may also be affected and breach of pharmacovigilance rules may have large financial consequences. In the fall of 2012, the EMA announced its first infringement procedure on pharmacovigilance, which may result in a fine of 5% of the holder’s Community turnover in the preceding business year.

This seminar is part of the Bird & Bird Compliance seminar series for the Life Sciences sector. Bird & Bird is running a series of seminars in 2013 and 2014 that focuses on various legal matters and developments that play an important role in the Life Sciences sector in general, and the medical devices sector in particular. In each seminar practical insights will be shared in how to comply with, and benefit from new and existing rules. We will send you more information about the seminar series soon.

Who should attend?

Legal counsels from pharmaceutical companies, Qualified Persons for Pharmacovigilance: EU-QPPVs.

This event is free of charge however prior registration is required. If you would like to attend please send an email to

The programme

13.30 - 14.00

Registration and refreshments

14.00 - 14.05

Welcome and introduction

Wouter Pors, Partner Bird & Bird The Hague

14.05- 14.40

More competences for the competent authorities: 

  • Conditional marketing authorisation;
  • Conditions to the marketing authorisation;
  • Union urgent procedure 

    Sally Shorthose, Partner Bird & Bird London 

    14.40 - 15.25

    An insiders' view on the activities of the PRAC

    Sabine Straus, Member of the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA and Head of the Pharmacovigilance department of the Dutch Medicines Evaluation Board (CBG-MEB)

    15.25 - 15.40


    15.40 - 16.15

    Changes affecting the marketing authorisation of the medicinal product

    • Imposed safety and efficacy studies, even after marketing authorisation
    • Implementation in the Dutch Medicines Act;
    • Supervision and enforcement in the Netherlands

      Hanneke Later-Nijland, Senior Associate Bird & Bird The Hague

      16.15- 16.50


      Wouter Pors, partner Bird & Bird The Hague

      16.50- 17.10

      Impact on the new pharmacovigilance rules for product liability

      Evelyn Tjon-En-Fa, Partner Bird & Bird The Hague

      17.10 onwards

      Canapés, drinks and networking