The extension of the requirement for an export authorisation for COVID-19 vaccines


From 13 March 2021 up to and including 30 June 2021, a new regulation has come into force (Regulation (EU) 2021/442) which concerns the requirement for an export authorisation of COVID-19 vaccines. This Regulation is an extension of an earlier Regulation on this topic (Regulation (EU) 2021/111). There are a number of changes.

What are the changes?

From now onwards, the Regulation also applies to active substances which come under the following GN codes:
• ex 2933.99.80
• ex 2934.99.90
• ex 3002.90.90
• ex 3504.00.90

Only those active substances used for the manufacturing of vaccines against SARS-related corona viruses (SARS-CoV types) are subject to the requirement for an export authorisation, as indicated by the word ‘ex’.


The new Regulation also applies in the event of re-export. The requirement for an export authorisation only applies if non-EU goods have been subject to manufacturing processes in the Customs Area of the European Union, such as filling and packaging. The requirement to have an export authorisation does not apply If a consignment for re-export has not been subject to a manufacturing process.

If a consignment is declared for re-export and an export authorisation is required, the export authorisation must be issued by the Member State in which the exporter has its place of business.

Authorisation for several consignments

The Regulation makes it possible to apply for 1 authorisation for 1 batch which is being processed by way of several consignments and via several customs declarations. It is only possible if the consignments have the same country of destination, however, the consignments may be sent to several addresses in that country. Essentially, all of the consignments for this one export authorisation must be processed by the same customs export office. The export authorisation must contain reference to the customs export office concerned.

Please note!

If 1 export authorisation applies to several consignments, the customs export office issues, signs and stamps the authorisation for each consignment. The customs office carries out the actions set out above prior to the export of the consignment.

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