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In brief

With EU Implementing Regulation 2021/442 of 11 March 2021, the European Commission introduced a new export authorization regime for COVID-19 vaccines applicable until 30 June 2021 which replaces the one initially established with EU Implementing Regulation 2021/111 of 29 January 2021. In particular, the new Implementing Regulation provides that the export outside the EU of vaccines and active substances classified with the identification codes listed therein is subject to prior authorization.

In more detail

In this respect, it should be noted that, on 24 March 2021, the European Commission further intervened on the export authorization mechanism for COVID-19 vaccines and active substances through the adoption of EU Implementing Regulation 2021/521, which introduced the principles of reciprocity and proportionality as new criteria for the granting of the authorization. According to said principles, the competent authorities of the Member State in which vaccines are manufactured or in which the exporter is established shall grant the export authorization provided that said authorization does not pose a threat to the security of supply within the EU.

Furthermore, the European Commission clarified that, in order to grant the authorization, the national competent authority must assess whether the country of destination of the export restricts its own exports of vaccines and active substances to the EU as well as the relevant conditions prevailing in the country of destination of the export, including the epidemiological situation, the vaccination rate and the existing availability of such products


Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.


Riccardo Ovidi is an associate in Baker McKenzie's Rome office.