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In brief

With Regulation (EU) 2021/111, adopted under the urgency procedure and published on January 29, 2021, the European Commission has established that until March 31, 2021, the export of COVID-19 vaccines outside the EU territory is subject to authorization. This authorization regime applies to exports of vaccines by pharmaceutical companies that have signed Advance Purchase Agreements (“APAs”) with the EU.

As part of the European strategy for the development, production and distribution of vaccines against COVID-19, the Implementing Regulation provides that an export authorization can be issued by the competent Authority of the Member State where vaccines are manufactured, provided that the volume of export does not pose a threat to the performance of APAs.


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.