Application for authorisation for the export of vaccines against COVID-19

On 29 January 2021, finding itself in a situation where the production and delivery of vaccines are still in a ramp-up phase, resulting in a temporary global shortage, the European Commission published Implementing Regulation (EU) 2021/111 making the export of certain products subject to an export authorisation.

According to Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation, it is important to maintain the protective measures until 30 June 2021 as the production capacity of COVID-19 vaccines is still in the building-up phase and remains, for certain vaccine manufacturers, below the pledged quantities to be destined for the Union on the basis of Advanced Purchased Agreements (APAs) concluded with the Union, and taking into account in particular the risk that vaccines produced or packaged in the Union are exported, especially to non-vulnerable countries, in potential breach of the contractual commitments made by the pharmaceutical industries.

The products for which an authorisation must be applied for in the Member State in which these products are manufactured are the following:

  • vaccines against SARS coronaviruses (SARS-CoV species) covered by CN code 3002 20 10, irrespective of their packaging; and
  • active substances including primary and working cell banks used for the manufacture of these vaccines, currently falling under CN codes ex 2933 99 80, ex 2934 99 90, ex 3002 90 90 and ex 3504 00 90.

The authorisation must be presented when the goods are declared for export, but at the latest when the goods are released.

The export of such products is prohibited without a valid export authorisation.

No authorisation is required for exports to the following destinations:

  • Republic of Albania;
  • Andorra;
  • Bosnia and Herzegovina;
  • Faroe Islands;
  • Republic of Iceland;
  • Kosovo;
  • Principality of Liechtenstein;
  • Montenegro;
  • Kingdom of Norway;
  • Republic of North Macedonia;
  • Republic of San Marino;
  • Serbia;
  • Swiss confederation;
  • Vatican City State;
  • Greenland;
  • New Caledonia and Dependencies;
  • French Polynesia;
  • French Southern and Antarctic Territories;
  • Wallis and Futuna Islands;
  • Saint Pierre and Miquelon;
  • Saint-Barthélemy;
  • Aruba;
  • Netherlands Antilles:
    • Bonaire;
    • Curaçao;
    • Saba;
    • Sint Eustatius;
    • Sint Maarten;
  • Anguilla;
  • Cayman Islands;
  • Falkland Islands;
  • South Georgia and the South Sandwich Islands;
  • Montserrat;
  • Pitcairn;
  • St. Helena and Dependencies;
  • British Antarctic Territory;
  • British Indian Ocean Territory;
  • Turks and Caicos Islands;
  • British Virgin Islands;
  • Bermuda;
  • Büsingen;
  • Helgoland;
  • Livigno;
  • Ceuta and Melilla;
  • Algeria;
  • Egypt;
  • Jordan;
  • Lebanon;
  • Libya;
  • Morocco;
  • Palestine;
  • Syria;
  • Tunisia;
  • Armenia;
  • Azerbaijan;
  • Belarus;
  • Georgia;
  • Israel;
  • Moldova;
  • Ukraine.

No authorisation is required for the following transactions:

  • exports to low- and middle-income countries on the COVAX AMC list;
  • exports of goods purchased or delivered through COVAX, Unicef and the Pan American Health Organisation (PAHO) with destination to any other COVAX participating country;
  • exports of goods purchased by EU Member States under Advanced Purchased Agreements and donated or resold to a third country;
  • exports in the context of a humanitarian emergency response; and
  • exports to facilities located on the continental shelf of a Member State or in the exclusive economic zone declared by a Member State pursuant to the United Nations Convention on the Law of the Sea.

Vaccine manufacturers with Advanced Purchased Agreements shall provide to the Commission (email address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu) and to the OCEIT (email address: oceit@eco.etat.lu) the relevant data concerning their exports since 30 October 2020, together with the first application for authorisation.

This notification must include the following information:

  • the volume of exports of vaccines against COVID-19;
  • the final destination;
  • the final recipients; and
  • a precise description of the products.

Failure to provide this information may result in export authorisations being refused.

The decision to grant an authorisation is subject to the condition that the volume of exports is not such that it poses a threat to the execution of advance purchase contracts concluded by the Union with vaccine manufacturers.

The applicant company will receive a decision on the granting of an export authorisation within 72 hours of the submission of a complete application. The application will be processed both by the Office for Export, Import and Transit Controls and by the European Commission within this time frame.

Forms / Online services

Biens de nature strictement civile – Vaccins contre les coronavirus du SARS – Exportation Demande d’autorisation

Les informations qui vous concernent recueillies sur ce formulaire font l’objet d’un traitement par l’administration concernée afin de mener à bien votre demande.

Ces informations sont conservées pour la durée nécessaire par l’administration à la réalisation de la finalité du traitement

Les destinataires de vos données sont les administrations compétentes dans le cadre du traitement de votre demande. Veuillez-vous adresser à l’administration concernée par votre demande pour connaître les destinataires des données figurant sur ce formulaire. Conformément au règlement (UE) 2016/679 relatif à la protection des personnes physiques à l'égard du traitement des données à caractère personnel et à la libre circulation de ces données, vous bénéficiez d’un droit d’accès, de rectification et le cas échéant d’effacement des informations vous concernant. Vous disposez également du droit de retirer votre consentement à tout moment.

En outre et excepté le cas où le traitement de vos données présente un caractère obligatoire, vous pouvez, pour des motifs légitimes, vous y opposer.

Si vous souhaitez exercer ces droits et/ou obtenir communication de vos informations, veuillez-vous adresser à l’administration concernée suivant les coordonnées indiquées dans le formulaire. Vous avez également la possibilité d’introduire une réclamation auprès de la Commission nationale pour la protection des données ayant son siège à 15, boulevard du Jazz L-4370 Belvaux.

En poursuivant votre démarche, vous acceptez que vos données personnelles soient traitées dans le cadre de votre demande.

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