The European Commission announced last week a new, mandatory export authorization requirement for COVID-19 vaccines covered by an Advance Purchase Agreement (APA) with the EU.

The new rule applies to vaccines against SARS-related coronaviruses (SARS-CoV species) falling under CN code 3002 20 10 and cover active substances including master and working cell banks used for the manufacture of such vaccines.

Effective Jan 30, 2021, companies exporting vaccines covered by Advance Purchase Agreement (APA) with the EU must obtain an export authorization from the competent authority in their country.  The goal of this new export authorization scheme is to increase transparency of vaccine exports outside the EU.  The European Commission has made it clear that this new requirement is not an export ban of vaccines. It is early notification and authorization system.

The EU Member States have already begun publishing guidance on their websites describing how the new export authorization procedure will take place. Currently, it appears that the Chamber of Commerce or Ministry of Trade in each country will be the competent authority tasked with issuing the export authorization.

The Commission has instructed Member States process applications for export authorizations as soon as possible and no later than two working days after receiving all the required information. It has also emphasized that this new rule does not apply to the exports of all vaccines from the EU, only those covered by an  Advance Purchase Agreement (APA) with the EU and even then, certain exemptions apply.

The APA is a European Commission program that financed part of the upfront costs faced by vaccines producers in the form of funding in return for the right to buy a specified number of vaccine doses. Funds provided under the APA where consider a down-payment on the vaccines that will be purchased by Member States.

Questions regarding this new EU export authorization can be sent to Marken at tradecompliance@marken.com