Medicinal products for human use

Public consultation on the concept paper on implementing measures for the performance of pharmacovigilance activities


Period of consultation

From 8 September 2011 to 7 November 2011.

Contributions to and results of the consultation

A summary of the responses is available here.

Below are the public responses to the above-mentioned public consultation:

Targeted stakeholders

All citizens and organisations (public and private) are welcome to contribute to this consultation.

Objective of the consultation

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.

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Specific privacy statement

Please consult the Privacy Statement to be downloaded here.

Additional information: