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In brief

On 25 November 2021, the European Commission adopted Implementing Regulation (EU) 2021/2071 subjecting vaccines against COVID-19 and active substances used for the manufacture of same to export surveillance for a period of 24 months starting from 1 January. This Regulation will replace the existing regulatory framework requiring vaccine exports to be subject to an authorization by Member States.

According to the new Regulation, manufacturers of vaccines and their active substances will no longer need to request an authorization for the export of vaccines outside the European Union, but will have to make an export or re-export declaration, indicating the applicable TARIC code and the relevant number of doses. The data relating to these declarations will then be collected by the customs authorities of the Member States, which will transmit the same to the European Commission so that it can take them into account in monitoring the epidemiological situation and take appropriate measures, where necessary.


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.

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