On 12 March 2021, the Official Journal published Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation, which requires an export authorisation to export (or re-export after such goods have been subject to manufacturing operations including filling and packaging within the customs territory of the Union) vaccines against SARS-related coronaviruses (SARS-CoV species) currently falling under CN code 3002 20 10, irrespective of their packaging and active substances, including master and working cell banks used for the manufacture of such vaccines, currently falling under CN codes ex 2933 99 80, ex 2934 99 90, ex 3002 90 90 and ex 3504 00 90.

The export authorisation listing the number of doses shall be granted by the competent authorities of the Member State where products covered by the Regulation are manufactured and shall be issued in writing or by electronic means. For the purposes of the Regulation, manufacturing shall include the filling and packaging of vaccines. If the goods covered by this Regulation are manufactured outside the Union, the export authorisation shall be granted by the competent authorities of the Member State where the exporter is established.

Without the production of a valid export authorisation, the exportation of the goods covered by the Regulation shall be prohibited. The following exports shall not be subject to the export authorisation:

  • exports to Albania, Andorra, Bosnia and Herzegovina, the Faroe Islands, Iceland, Kosovo, Liechtenstein, Montenegro, Norway, North Macedonia, San Marino, Serbia, Switzerland, Vatican City, the overseas countries and territories listed in Annex II to the Treaty on the Functioning of the European Union, Büsingen, Helgoland, Livigno, Ceuta and Melilla, Algeria, Armenia, Azerbaijan, Belarus, Egypt, Georgia, Israel, Jordan, Lebanon, Libya, Moldova, Morocco, Palestine, Syria, Tunisia, and Ukraine [Note: countries that form part of that customs territory, such as Monaco, need not to be exempted in order to receive unrestricted shipments from within the Union];
  • exports to low- and middle-income countries in the COVAX AMC list;
  • exports of goods purchased or delivered through COVAX, Unicef and PAHO with destination to any other COVAX participating country;
  • exports of goods purchased by Member States under the APAs entered into by the Union and donated or resold to a third country;
  • exports in the context of a humanitarian emergency response;
  • exports to facilities located on the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to UNCLOS.

The request for export authorisation shall contain the information set out in Annex I to the Regulation and the applicable TARIC additional codes in Annex II. In addition it shall also contain information on the number of vaccine doses of goods covered by this Regulation distributed in the Union since 1 December 2020 broken down by Member State as well as information on the number of vaccine doses of goods covered by this Regulation distributed in Northern Ireland since the entry into force of Implementing Regulation (EU) 2021/111.

The Regulation shall enter into force on 13 March 2021 and apply until 30 June 2021.

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