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The Italian Government has blocked the export of 250,700 doses of COVID-19 vaccine to Australia. This decision represents the first application of the newly enacted EU transparency and authorization mechanism for exports of COVID-19 vaccines provided for by Implementing Regulation (EU) 2021/111 of January 29, 2021.

This mechanism establishes that, until March 31, 2021, exports of COVID-19 vaccines are subject to the prior authorization by the Member State where products are manufactured with the purpose of ensuring timely access to COVID-19 vaccines for all EU citizens. The above-mentioned authorization regime only applies to exports of vaccines manufactured by pharmaceutical companies that have entered into Advance Purchase Agreements with the EU.

The proposal for refusal was submitted to the European Commission and, following its approval, the decision rejecting the export authorization has been formally notified to the manufacturer on March 2, 2021.

Author

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.

Author

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

Author

Irene Carlet is a Law Clerk/Intern in Baker McKenzie's Rome office.