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Parliamentary questions
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1 October 2021
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: E-001512/2021

In accordance with EU pharmaceutical legislation(1), the Commission granted marketing authorisations for COVID-19 vaccines after the European Medicines Agency concluded on the positive benefit-risk related to their use, based on evaluation of data on quality, safety and efficacy. S afety of vaccines continues to be monitored(2) and regulatory measures can be taken, if appropriate.

The Commission has ensured that the contracts for COVID-19 vaccines are compliant with EC law and respect and protect citizens’ rights, in line with the Product Liability Directive(3). In accordance with the EU product liability rules, liability remains with the manufacturer.

In case of damages claimed to be caused by the vaccine administration, the injured person has the right to seek compensation from the manufacturer. According to the Product Liability Directive, any damages claim will need to be made before the competent court with a proof of the damage, the defect and the causal relationship between defect and damage.

At this stage, the Commission is not planning to constitute an ad-hoc compensation fund.

(1)Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, as amended, Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, as amended.
(2)COVID-19 vaccines: development, evaluation, approval and monitoring | European Medicines Agency (europa.eu)
(3)Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.
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