In July 2012, new pharmacovigilance legislation comes into effect across the EU.
The new legislation aims to strengthen patient safety by improving the present system used for monitoring safety of medicines in Europe.
Info meeting for the pharmaceutical industry
In November 2011, the Danish Medicines Agency (now the Danish Health and Medicines Authority) hosted a meeting for the pharmaceutical industry on the implications of the new legislation, and a follow-up meeting will be held on 11 September 2012. The meeting will be in Danish. We will post the meeting programme and registration information here on the website later.
Objective of the new legislation
Overall, the new legislation aims to ensure:
- strong scientifically and internationally based decisions through a risk-based approach
- a high degree of transparency and information for the public as well as involvement of patients
- rational processes and cooperation for maximum utilisation of resources and elimination of unnecessary duplication.
The new legislation transpose changes set out in Directive 2010/84/EU and Regulation (EU) No1235/2010, which were adopted by the Council of Ministers and the European Parliament in December 2010.
In addition, an implementing regulation on the performance of pharmacovigilance activities provided for in the regulation the directive has been adopted.
Rules are underpinned by guideline modules
The rules of the new regulation are underpinned by a number of guideline modules (Good Vigilance Practice – GVP modules), each addressing different major elements in the new legislation.
The GVP modules have been prepared by teams consisting of experts from the European Medicines Agency (EMA) and from the national authorities in the EU Member States.
The first seven GVP modules were released for public consultation in spring 2012.
Stay updated on changes here on the website
The new pharmacovigilance legislation will imply changes for authorities, industry, doctors and citizens.
In addition to the meeting that will be held for the industry in September, the Danish Health and Medicines Authority will publish information about news in the area here on the website.
Questions and answers
To support the implementation of the new legislation, we have prepared questions and answers in the area of pharmacovigilance in a questions and answers document. We will update this document regularly.
You can use this document in conjunction with the questions and answers that EMA has published on its website: Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation
EMA has published information about the overall impact of the new legislation: 2010 pharmacovigilance legislation
The European Commission has published information on how to approach the changes of the new legislation during the transition period. Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance rules
EMA has published an implementation plan, describing which elements of the new legislation are expected to be implemented in 2012 and which elements of the legislation will be in focus beyond 2012. Plan for implementation of the pharmacovigilance legislation by the European Medicines Agency
EMA will also be hosting a series of stakeholder meetings on the new legislation: Working with the pharmaceutical industry on implementation of the pharmacovigilance legislation