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Governo Italiano

Authorisation mechanism for exports of COVID-19 vaccines



Authorisation mechanism for exports of COVID-19 vaccines

“In an effort to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU, the European Commission has adopted Implementing Regulation (EU) 2021/111 of 29 January 2021. The Regulation has established an authorisation mechanism for exports of COVID-19 vaccines and active substances to ensure the necessary transparency and compliance with the Advanced Purchase Agreements (APAs) concluded by the EU with the pharmaceutical companies.

Regulation 2021/111, which entered into force on 30 January 2021, has been superseded by Implementing Regulation (EU) 2021/442, effective from 12 March until 30 June 2021, under which the manufacturers of the vaccines (CN code 3002 20 10) or of the relevant active substances (CN codes ex 2933 99 80, ex 2934 99 90, ex 3002 90 90 and ex 3504 00 90) are now subject to the obligation to request prior authorisation from the Member State in which the said products are manufactured or, in any case, packaged, for export to non-EU countries.

In Italy’s case, the requests for export authorisations shall be submitted to the Ministry of Foreign Affairs and International Cooperation, by compiling two specific forms available at the following links:

bilingual IT EN export authorisation request form

export authorisation request table with doses already exported to EU countries and Northern Ireland

The request shall be submitted by the legal representative of the exporting company or by an intermediary operator (with ID) expressly authorised by the exporter to export the COVID-19 vaccines.

The requests shall be sent by certified email to the following address:

Each authorisation request shall be accompanied by:

  •        The exporter’s authorisation, if required;
  •        A self-declaration by the exporter, or other commercial operator, stating that:

a) the information provided in the request form is accurate and is provided in good faith;

b) the documents produced conform to those in its possession, with the undertaking to preserve them for five years;

c) it is established in Italy;

  •        The personal data processing consent form, within the meaning and for the purposes of article 13 of Regulation (EU) No. 2016/679. 

If the requirements in article 1(7) of the said Implementing Regulation (EU) No. 2021/442 are met, subject to verification by the European Commission, the relevant authorisation shall be granted in accordance with the procedure referred to in the said Regulation and, in any case, within 4 working days from receiving the full information by certified email (this term may be extended by a further 2 working days under exceptional circumstances and for duly justified reasons).

Exports to the non-EU countries referred to in article 1(9) of Regulation No. 2021/442 shall not be subject to export authorisation.

For further information please visit the website of the European Commission.

For inquiries, please send an email to the following address, if necessary specifying a return address:

Rome, March 12, 2021”

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