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Parliamentary questions
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17 February 2021
E-006511/2020(ASW)
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: E-006511/2020

The Commission was not informed about the interim results of the World Health Organisation Solidarity Trial during the negotiations with Gilead.

The European Medicines Agency (EMA) has requested access(1) to the data from the Solidarity Trial. Once the data are available, EMA will assess the evidence, together with other relevant data, to see if any changes are needed to the marketing authorisation of Veklury (remdesivir) in the EU.

The Commission does not plan to renegotiate the contract, as remdesivir continues to have a conditional marketing authorisation(2).

The maximum amount in the framework contract(3) is determined by the needs identified during the procedure by the EU Member States and other countries(4) participating in this joint procurement.

(1)https://www.ema.europa.eu/en/news/update-remdesivir-ema-will-evaluate-new-data-solidarity-trial
(2)https://ec.europa.eu/health/documents/community-register/html/h1459.htm
(3) https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health_en#ensuringtheavailabilityofsuppliesandequipment
(4)https://ec.europa.eu/health/preparedness_response/joint_procurement/jpa_signature_en#
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