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In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (
Export Authorization Regulation) which is in force from 30 January 2021. The Commission intends for the Export Authorization Regulation to apply until at least 31 March 2021.
The Export Authorization Regulation stipulates that certain exports of the COVID-19 vaccine will require prior notification and authorization from competent authorities of the EU member states where the COVID-19 vaccines are manufactured. Member states are required to set up such authorization regimes and the Commission will issue binding opinions on whether such authorizations should be granted, taking into account their likely impact on the ability of vaccine manufacturers to meet their obligations under Advance Purchase Agreements (APAs) concluded with the European Union.