​Authorisation mechanism for exports of COVID-19 vaccines
Navigate Up
Sign In

​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 lack of transparency of vaccine exports outside the EU, on the 29th of January 2021 the Commission adopted Implementing Regulation (EU) 2021/111 subjecting such exports to an authorisation by Member States. This scheme only applies to exports from companies with whom the EU has concluded Advance Purchased Agreements and was meant to run until the end of March. 

However, in view of persistent delays in some of the deliveries of vaccines to the EU, the Commission extended the transparency and authorisation mechanism for COVID-19 vaccine exports until end of September through Implementing Regulation 2021/442​​​​ . On the 24th of March, the European Commission amended the Implementing Regulation​ to introduce two changes to the existing mechanism whereby in addition to the impact of a planned export to the fulfilment of the EU's Advance Purchase Agreements (APAs) with vaccine manufacturers, Member States and the Commission will also consider:

Reciprocity – does the destination country restrict its own exports of vaccines or their raw materials, either by law or other means? 

Proportionality – are the conditions prevailing in the destination country better or worse than the EU's, in particular its epidemiological situation, its vaccination rate and its access to vaccines.

The Commission Implementing Regulation (EU) 2021/521​ of 24th March 2021 has introduced additional arrangements for a period of six weeks. ​

Exporters whose items fall under the scheme are required to apply for an export licence from the Commerce Department. The application form​ is to be filled in and returned by email to controlledgood@gov.mt together with the below supporting documentation where applicable:

Vaccines manufacturers that have concluded APAs shall provide, with the first request for authorization, data concerning their exports in the last three months prior to entry into force of Implementing Regulation (EU) 2021/111 – January 30th. The information is to include the volume of exports of COVID-19 vaccines, the final destination and the final recipients and a precise description of the product under the form of a table containing the number of doses per destination and recipient (row) and exported per week (column) in Excel or Word format.

The number of vaccine doses of goods covered by Implementing Regulation (EU) 2021/442, distributed 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 – January 30th, in Excel or Word format.

Enquiries may be directed to controlledgoods@gov.mt or 21226688.

Application form ​

FAQs published by the European Commission (March 2019)​

Presentation by the European Commission on the vaccine exports temporary transparency and authorisation mechanism​

Last update 20.04.21