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Italy: Covid-19 – European Commission establishes an authorization mechanism for the export of vaccines

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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.

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Author

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.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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