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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 has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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