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Import and export rules | Brussels, 11 March 2021

Commission extends transparency and authorisation mechanism for exports of COVID-19 vaccines

The Commission has today extended until end of June the transparency and authorisation mechanism for COVID-19 vaccine exports. This follows persistent delays in some of the deliveries of vaccines to the EU.

Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “The first weeks of the application of this instrument have shown that the trade disruption feared by many did not take place. Since the measure was introduced, shipments were authorised to more than 30 countries. This confirms that even during a very critical health situation, the EU has made a considerable effort to be a reliable and responsible trading partner.”

Commissioner for Health and Food Safety Stella Kyriakides said: “We expect companies with which we have signed a contract to fulfil their obligations towards EU citizens. The EU exports very significant volumes of COVID-19 vaccines, true to our commitment to global solidarity. Yet, not all companies are honouring their agreements with the EU despite having received a down payment to enable sufficient production. We will insist that compliance is ensured and we will continue to work with companies to ramp up production in Europe as quickly as possible.”

EU number one supplier of COVID-19 vaccines to the world

The EU continues to be the leading provider of vaccines around the world. Six weeks into the existence of this mechanism, 249 export requests to 31 different countries* have been granted for a total of 34.090.267 doses, as they did not threaten the contractual engagements between the EU and the vaccine producers. Only one export request was not granted. The main export destinations include the United Kingdom (with approximately 9.1 million doses), Canada (3.9 million), Mexico (3.1 million), Japan (2.7 million), Saudi Arabia (1.4 million), Hong Kong (1.3 million), Singapore (1 million), United States (1 million), Chile (0.9 million) and Malaysia (0.8 million).

The export authorisation mechanism

This export authorisation mechanism only applies to exports from companies with which the EU has concluded Advance Purchase Agreements (APAs). These APAs commit the vaccine producers to deliver to EU Member States a pre-agreed number of vaccines. The mechanism provides for authorisations of exports of COVID-19 vaccines outside the EU.

Initially put in place on 30 January 2021, and with a timeframe lasting until the 12 of March 2021, the new regulation extends the duration of this mechanism until the end of June 2021. The new regulation also simplifies the procedure by allowing the grouping of exports to different final recipients in the same country in one single request. It also provides clarity by identifying the customs codes for the active substances covered by the measure.

This measure is targeted, proportionate, transparent and temporary. It is fully consistent with the EU's international commitments under the World Trade Organization and the G20, and is in line with what the EU has proposed in the context of the WTO Trade and Health Initiative. Committed to international solidarity, the EU excluded from this mechanism vaccine supplies for humanitarian aid or those supplies destined to countries under the COVAX Facility, as well as shipments to our neighbourhood.**

About the EU's vaccine strategy

The European Commission presented on 17 June a European strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements (APAs). Funding provided is considered as a down-payment on the vaccines that are actually purchased by Member States. The APA is therefore a de-risk investment upfront against a binding commitment from the company to pre-produce, even before it gets marketing authorisation. This should allow for a quick and steady delivery as soon as the authorisation has been granted.

The Commission has so far signed APAs with six companies (AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNtech-Pfizer, CureVac, and Moderna), securing access to up to 2.6 billion doses. Negotiations are advanced with two additional companies. The four contracts with the companies whose vaccines have been granted conditional marketing authorisation amount to more than 1.6 billion doses.

For more information

Frequently asked questions
Commission Implementing Regulation and Annexes
Press release for the initial adoption of the mechanism


* Argentina, Australia, Bahrain, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Oman, Panama, Peru, Qatar, Republic of Korea, Saudi Arabia, Singapore, South Africa, Turkey, United Arab Emirates, United Kingdom, United States and Uruguay.

** Countries excluded from the measure: countries and economies close to the EU, such as the EFTA countries or the Western Balkans, which are engaged in a process of deep integration with the Union, but also countries and territories that depend on the EU for supplies: Albania, Andorra, Bosnia and Herzegovina, the Faeroe Islands, the Republic of Iceland, Kosovo, the Principality of Liechtenstein, Montenegro, the Kingdom of Norway, the Republic of North Macedonia, the Republic of San Marino, Serbia, the Swiss Confederation, Vatican City State, the overseas countries, territories listed in Annex II of the Treaty of the Functioning of the European Union, and exports to Büsingen, Heligoland, Livigno, Ceuta and Melilla, and the low and middle-income countries in the COVAX Advance Market Commitment list: Afghanistan, Algeria, Angola, Bangladesh, Benin, Bhutan, Bolivia, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Côte d'Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Egypt, El Salvador, Eritrea, Eswatini, Ethiopia, Fiji, Gambia, Ghana, Grenada, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Kenya, Kiribati, Kosovo, Kyrgyzstan, Laos, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Micronesia, Moldova, Mongolia, Morocco, Mozambique, Myanmar/Burma, Nepal, Nicaragua, Niger, Nigeria, North Korea, Pakistan, Papua New Guinea, Philippines, Rwanda, Saint Lucia, Saint Vincent and the Grenadines, Samoa, São Tomé and Principe, Senegal, Sierra Leone, Solomon Islands, Somalia, South Sudan, Sri Lanka, Sudan, Syria, Tajikistan, Tanzania, Timor-Leste, Togo, Tonga, Tunisia, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe.