On Wednesday 30 November the Medicines Evaluation Board (MEB) organised an informative meeting in Utrecht about the implications of the new pharmacovigilance legislation. This meeting was primarily targeted at marketing authorisation holders.
The new legislation comes into effect on 1 July 2012 and also has implications for pharmaceutical companies. Because of the broad scope of these implications, the MEB chose to address three main subjects, partly based on the questions the attendants could supply in advance.
- Overview of the new legislation
- PSURs, changes in content and procedures
- Transparancy
- Reporting of suspected adverse reactions
During an interactive discussion a panel of representatives of the MEB answered remaining questions.
To keep stakeholders informed and engaged, the MEB launched a new website (www.pharmacovigilance2012.nl) and the MEB is planning subsequent meetings on this topic (expected April 2012).
More information
1. Opening and programme 30 November 2011
2. Overview new legislation 30 November 2011
3. PSURs content 30 November 2011
4. PSURs procedures 30 November 2011
5. Transparancy 30 November 2011
6. Reporting of suspected adverse reactions 30 November 2011
