Corona: Mandatory export licence for COVID-19 vaccines (update)
From 30 January 2021, there will be a licensing requirement for the export of COVID-19 vaccines to countries outside the European Union (EU). The compulsory licence concerns the vaccine as a whole, but also the individual active substances thereof.
Why a licensing requirement?
"In order to remedy a critical situation and to ensure transparency, it is in the Union interest to take immediate action for a limited duration to ensure that exports of COVID-19 vaccine covered by Advanced Purchased Agreements (APA) with the Union are subject to a prior authorisation so that they are adequate supplies in the Union to meet the vital demand, but without impacting on the Union’s international commitments in this respect."
This text is included in one of the articles of the Implementing Regulation. The regulation ensures that enough vaccines are available within the EU to protect the residents of the EU against COVID-19 as soon as possible. The regulation went into effect on Saturday, 30 January 2021. Without a valid export licence, the export of COVID-19 vaccines or the active substances thereof is prohibited with immediate effect.
What does the mandatory licence apply to?
The licensing requirement applies to vaccines against all SARS-related coronaviruses (SARS-CoV species, including COVID-19) falling under CN code 3002 20 10. Regardless of the packaging. The licence also covers its active substances, including the parent cell banks and working cell banks used to make the vaccines.
The regulation regulates exports outside the EU.
The regulation contains several exceptions to the licensing requirement. This includes a large number of countries, certain international organisations and emergency humanitarian aid purposes.
Update: Applying to IGJ for an authorisation in the Netherlands
Please submit your application for the authorisation to the competent authority of the EU Member State where the vaccines are produced. For the Netherlands, that is the Inspectorate for Health and Youth Care (Inspectie Gezondheidszorg en Jeugd, IGJ). More information about the export of COVID-19 vaccines is available on the IGJ website (only available in Dutch).