With a view to ensure timely access to COVID-19 vaccines for all EU citizens and to deal with the current lack of transparency in the export of such vaccines outside the territory of the Union, the European Commission adopted Implementing Regulation N. 2021/11 of 29 January 2021, which entered into force on 30 January 2021. The Regulation established a new export authorization mechanism for vaccines and anti-COVID-19 active substances to ensure the necessary transparency and compliance with Advance Purchase Agreements (APA) concluded by the Union with pharmaceutical manufacturing companies.
Regulation N. 2021/111 was then replaced by Implementing Regulation N. 2021/442, the latter in force from 13 March to 30 June 2021 and subsequently amended and supplemented by Implementing Regulation N. 2021/521, in force since last 26 March.
The combined provisions of Regulations N. 442 and N. 521 require companies producing the vaccine (CN code 3002 20 10), or the active substances used in its manufacture (CN code ex 2933 99 80, ex 2934 99 90, ex 3002 90 90 and ex 3504 00 90), for export to non-EU countries to apply for a specific authorization from the Member State where such products are manufactured or packaged.
In the case of Italy, the application for authorization must be submitted to the Ministry of Foreign Affairs and International Cooperation, by filling in the two appropriate forms available at the following links:
The application may be submitted by the legal representative of the exporting company or by an intermediary trader equipped with an express authorization granted by the exporter (and accompanied by National ID) to export anti-COVID-19 vaccines.
Application must be received by certified e-mail at the following address: email@example.com.
The application for authorization must be accompanied by:
- Authorization from the exporter, if any;
- Self-declaration of the exporter or economic operator stating that:
a) that the information contained in the application form is accurate and provided in
b) that the documents produced correspond to those in his possession and that he undertakes
to keep them for five years;
c) that he is established in Italy;
- Consent to data processing pursuant to and for the purposes of art. 13 of Regulation N. 2016/679.
In the presence of the necessary prerequisites indicated in art. 1(7) of the aforementioned Regulation N. 2021/442, as last supplemented by art. 2 of Regulation N. 2021/521 and subject to verification by the European Commission, the authorizations will be issued within the terms provided for by the aforementioned Regulation, and in any case within 4 working days from receipt of the CEM complete with all the information (which may be extended by a further 2 days in the event of exceptional circumstances and for duly justified reasons).
Sales to non-EU countries as defined in Article 1 (9) of Regulation 2021/442 are exempt from the export authorization requirement. However, it should be noted that, with Regulation 2021/521, the Commission has currently suspended the exemptions for 17 of these third countries (see Article 1), to which the obligation to apply for a formal authorization now applies.
- Bosnia and Herzegovina
- North Macedonia
For further details, please consult the European Commission’s website.
For any further information, please write to the following e-mail addresses and indicate your contact details:
1 - Conversely, the following countries remain exempt from the licensing mechanism: Andorra; the Faroe Islands; San Marino; the Vatican City; Büsingen, Heligoland; Livigno; Ceuta and Melilla; the overseas countries and territories listed in Annex II of the Treaty on the Functioning of the EU; and the low- and middle-income countries included in the COVAX AMC list.