22nd March 2021 |
The European Commission has extended the temporary transparency and authorisation mechanism for exports of COVID-19 vaccines to countries outside of the EU. This mechanism applies to exports to countries outside of the EU of COVID-19 vaccines, and active substances used in their manufacture, from companies with whom the EU has concluded Advance Purchased Agreements. These exports will be subject to prior authorisation by the National Competent Authority of the Member State of the EU in which the goods are manufactured.
The European Union has supported the rapid development and production of several vaccines against COVID-19 with a total investment of €2.7 billion and it is acting to protect the integrity of this substantial investment. The objective of this measure is to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the European Union.
The mechanism does not restrict the free circulation of these goods among the 27 EU member states of the EU, nor does it apply to transfers between the EU and Northern Ireland. Exports to a large list of third countries, including low- and middle-income countries, are exempt from the mechanism.
The new Commission Implementing Regulation simplifies the procedure for manufacturers by allowing the grouping of exports to multiple final recipients in the same country in a single application for Export Authorisation to the National Competent Authority. It also provides greater clarity by identifying the customs codes for the active substances covered by the measure.
The European Commission has also clarified that active substances are only covered by the mechanism when they are to be used for the manufacture of SARS-related coronavirus vaccines. Active substances that can, theoretically, be used for these vaccines but are being exported for a different use, are outside the scope of the mechanism.
The Commission has advised that exports of small quantities of samples for the conduct of clinical trials should be swiftly authorised as they do not threaten the execution of APAs.
This measure will be in effect from 13 March until 30 September 2021.
The European Commission’s Press Release and Q&A provide further explanation of the mechanism and full details are set out in the Commission Implementing Regulation.
The Competent Authority will grant an Export Authorisation in accordance with the European Commission’s opinion on whether the proposed export poses a threat to the execution of EU Advance Purchased Agreements concluded with vaccines manufacturers.
The Department of Enterprise, Trade and Employment is the National Competent Authority with responsibility for administering and enforcing the Regulation in Ireland. The Department is coordinating closely with the Department of Health and Revenue on the implementation of the Regulation. Companies seeking to export goods, manufactured in Ireland and covered by the Regulation, outside the EU must apply to the Department for an Export Authorisation. The Authorisation document must then be produced to Revenue when the goods are declared for export.
Companies seeking an Export Authorisation should download the Application Form and return a scanned copy of the completed Form to the Department at firstname.lastname@example.org.
EU Affairs, Trade Policy and Licensing