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Parliamentary questions
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28 April 2021
P-001043/2021(ASW)
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: P-001043/2021

All COVID-19 vaccines that have received a conditional marketing authorisation from the Commission have been assessed with regard to their quality, safety and efficacy.

The Commission normally authorises a vaccine in the EU following a positive scientific opinion by the European Medicines Agency confirming a positive benefit-risk-ratio for that product.

Information on possible known side effects is published in the product information, and marketing authorisation holders are obliged to record and inform of any new case report about adverse events to ensure a tight safety monitoring in line with the pharmacovigilance provisions of the EU pharmaceutical legislation.

In this area, the limited competence of the EU when it comes to health policy has to be taken into account. The definition of health policy, as well as the organisation and delivery of health services and medical care, including their management and the allocation of the resources assigned to them, is a Member State competence under Article 168 of the Treaty on the Functioning of the EU. The Commission is therefore not in a position to intervene and regulate the type of side effects that should be compensated.

In view of the answer to the first question, communication about compensation procedures for side effects should take place at national level.

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