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Parliamentary questions
6 September 2018
E-004178/2018
Answer given by Mr Andriukaitis on behalf of the European Commission

With regard to the effectiveness of the EU system to monitor the continuous safety of medicines once they are authorised (pharmacovigilance — PhV), it should be stressed that medicines in the EU are subject to strict post-marketing surveillance for which obligations to marketing authorisation holders and competent authorities are set by EU legislation and therefore harmonised. These obligations have been further strengthened following revisions in 2010 and 2012.

As a result, the EU PhV system is one of the most advanced and comprehensive in the world and represents a robust and transparent instrument to ensure a high level of public health protection throughout the EU.

Concerning Levothyrox, the Commission would like to refer to its answer to question E-003511/2018. In the context of the formulation change, national competent authorities sought advice from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) on any potential safety concerns with the new formulation.

Based on the available information, the PRAC agreed that there is no difference in the pattern of adverse events reported before and after the switch to the new formulation.

The PRAC also advised to undertake close monitoring and supervision during the transition period for all patients to ensure that the patient’s individual dose remains appropriate.

The Commission disagrees with the suggestion that the EU marketing authorisation system should be replaced by a global system. Medicines are not goods like any other and require a strong and comprehensive regulatory system within the jurisdiction of the EU. This does not exclude continuous cooperation with partner authorities in other regions of the world, which is already underway.

Last updated: 7 September 2018Legal notice