Import and export rules | Brussels, 26 November 2021

The EU will not extend the COVID-19 vaccines export transparency and authorisation mechanism, which expires on 31 December 2021. This means that, as of 1 January 2022, vaccine producers will no longer have to request an authorisation for the export of vaccines outside the EU.

Transparency of exports will continue to be ensured through a new monitoring mechanism that will provide the European Commission with timely, company-specific vaccine export data. The Commission will continue to monitor the ongoing epidemiological situation in order to take appropriate measures if necessary.

This decision is part of broader EU efforts to facilitate the widest and fastest production and equitable distribution of COVID-19 vaccines that the world urgently needs:

• The EU is the biggest global provider of COVID-19 vaccines with over 1.3 billion doses exported so far, more than half of its production.
• The EU will also donate at least 500 million doses to the most vulnerable countries over the next few months.
• The EU has committed €1 billion to create manufacturing hubs in different regions in Africa with our African partners and our industrial partners. The aim is to ramp up permanent vaccine production capacity and distribute it better across the world.
• The EU has been actively engaged in seeking agreement within the World Trade Organization (WTO) of a holistic response to the COVID-19 pandemic so as to facilitate production and export of vaccines and other essential medicines.

Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “The EU has been at the forefront of the global vaccination effort. We have exported over half our vaccines production and we have supported and funded initiatives such as COVAX, which help to ensure vaccine access to those parts of the world most in need. Mindful of our global responsibilities, I am pleased that we will now replace our current authorisation system with a new monitoring mechanism to get precise data on our exports. There is still important work to be done in the drive to vaccinate the world, therefore we will redouble our efforts on all fronts at the upcoming WTO Ministerial meeting to ensure a holistic global response to the pandemic.”

Commissioner for Health and Food Safety Stella Kyriakides said: “Vaccinating the world is a necessity to overcome the COVID-19 pandemic. For us it was never about the EU first, vaccine solidarity was our hallmark from the outset. The EU has shown solidarity even at the most difficult times and exported well over half of the vaccine doses we have produced to other countries of the world. We will continue doing so while maintaining transparency and information sharing on our exports, leading the global efforts to save lives and end this global health crisis.”

The new monitoring mechanism will ensure a continued and timely collection of data on the exports of COVID-19 vaccine doses and the active substances to produce such vaccines at company level. Customs authorities of EU Member States will be collecting this data. The Commission will be making this data public at an aggregate level.

The purpose of the vaccines export transparency and authorisation mechanism was to secure deliveries of vaccines to Europeans in line with companies' contractual obligations. The system has significantly improved the transparency of vaccines production, deliveries and supply chains. It has also shown that the EU is a global leader in terms of vaccines exports. Deliveries of COVID-19 vaccine doses in the Union have been continuing at an increasing pace, resulting in the clear progress of the vaccination campaign in the Union. However, our vaccination campaign is still ongoing, and uncertainties remain. With new outbreaks of the virus in the EU and the risk of new variants of the COVID-19 virus, there is still a need for transparency of exports of vaccines, which the EU will continue to do under the new monitoring mechanism.

For more information

Commission Implementing Regulation