Medicinal products

Public consultation on the delegated act on post-authorisation efficacy studies


Period of consultation

From 28 November 2012 to 18 February 2013.

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:

Industry Associations

Individual Companies

Public Institutions

Academia & Healthcare professionals

Other stakeholders and individuals

Targeted stakeholders

All citizens and organisations (public and private) are invited to contribute.

Objective of the consultation

Post-authorisation efficacy studies are studies which are undertaken after a medicine has been authorised with the purpose of providing more information on the efficacy of the product within the authorised indications.

Those studies are not an entirely new feature, already now post-authorisation efficacy studies may be conducted. However, with the new pharmacovigilance legislation those studies are formally recognised. It is clarified that marketing authorisation holders can be obliged to conduct such studies by imposing that obligation as a condition to the marketing authorisation. Moreover, competent authorities may require the performance of such studies even post-authorisation, if new scientific evidence indicate that previous efficacy evaluations might have to be revised significantly.

In this context the Commission is empowered to adopt a delegated act laying down the situations in which post-authorisation efficacy studies may be required.

In order to further explore the added-value and the content of such an act the Commission has prepared a reflection paper which is now being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.

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: