In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation (cf. Regulation (EU) No 1235/2010 and Directive 2010/84/EU) the Commission shall adopt several implementing measures. Those measures supplement essential details of the new pharmacovigilance system with the more technical details that have to be observed by marketing authorisation holders, national competent authorities and the European Medicines Agency in the daily practice of applying the new provisions.
With the public consultation the European Commission intends to describe the scope and content of the implementing measure which it is currently considering and seeks views and feedback from stakeholders on those issues. A more detailed description can be found in the concept paper
[109 KB] .The period of consultation ends on 7 November 2011. All citizens and organisations (public and private) are welcome to contribute to this consultation. For more information on how to contribute, please read the concept paper.
Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation, read the specific Privacy Statement
[16 KB] .Sources
Public Health
Pharmanews
