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Request for authorisation to export COVID-19 vaccines filed by AstraZeneca

On 24 February, the Ministry of Foreign Affairs received a request for authorisation to export COVID-19 vaccines from AstraZeneca, in accordance with the Commission Implementing Regulation (EU) 2021/111, approved on 30 January 2021, “making the exportation of certain products subject to the production of an export authorisation”.

In previous cases of authorisation requests received from AstraZeneca, Italy – in agreement with the Commission – granted its clearance, as these were small quantities of samples intended for scientific research activities.

However, this latest request concerned 250,700 doses of vaccine. Therefore, the Foreign Ministry, after consulting with the other competent Italian Authorities – all of which expressed a negative opinion – sent a non-authorisation proposal to the European Commission, on 26 February, which, according to the Regulation, has the final say given that the Member State decides “in accordance with the Commission’s opinion”.

The reasons underlying Italy’s proposal not to allow the request are as follows:

  • the fact that the country of destination of the supply (Australia) is considered “non-vulnerable”, within the meaning of the Regulation;
  • the ongoing shortage of vaccines in the EU and Italy and the delays in the supply of vaccines by AstraZeneca to the EU and Italy;
  • the large number of vaccine doses referred to in the request for export authorisation compared to the quantity of doses so far supplied to Italy and, more generally, to EU countries.

Italy’s proposal to deny the authorisation was subsequently approved by the European Commission and the Ministry of Foreign Affairs then formally issued the export denial order on the same day, which was notified to the other party on 2 March 2021.