Export authorisation requirement for COVID-19 vaccines and vaccine components extended

Export authorisation requirement for COVID-19 vaccines and vaccine components extended

The European Union will continue the duration of its export authorisation requirement for vaccines against SARS-related viruses (SARS-CoV-2) and vaccine components until 30 June 2021. At the same time, clarifications will be made to the export authorisation scheme’s scope of application, and re-export will become subject to pre-authorisation. In Finland, applications for export authorisation are submitted to the Ministry for Foreign Affairs. Finland forms its preliminary position on an application based on a statement issued by the Finnish Medicines Agency, and the decision to grant an export authorisation is made in line with the opinion of the European Commission.

The export authorisation requirement concerning vaccines against SARS-related coronaviruses (SARS-CoV species), issued by the European Commission, which entered into force on 30 January 2021, will be extended until 30 June 2021.  

The RegulationLink to another website.(Opens New Window) will be applied to vaccines against SARS-related coronaviruses (SARS-CoV-2 species), falling under CN codeLink to another website.(Opens New Window) 3002 20 10 irrespective of their packaging. The scope of application also covers active substances, including master and working cell banks. 

Clarifications have also been made to the range of products covered by the scope of application by adding the CN codes of the substances and stating that re-export is subject to pre-authorisation. The authorisation procedure concerning multiple export consignments to the same country will be facilitated.  

Authorisations for transfers within the European Union are not required. The export authorisation requirement includes several exemptions. For example, certain neighbouring countries of the EU in Western Balkans, Eastern Europe and the Mediterranean are exempted from an authorisation. These countries and regions are listed in Article 1 of the RegulationLink to another website.(Opens New Window)

In Finland, there is not currently significant potential for export in goods subject to controls, but export control and authorisation procedures are in place in Finland as part of Finland’s activities as a Member State of the EU.  

The national licensing authority is the Ministry for Foreign Affairs.

To get a form for submitting an application for authorisation in Finland, please send email to the Ministry for Foreign Affairs  at [email protected] The Ministry for Foreign Affairs is preparing an online application, which is expected to be ready in mid-April 2021. 

Exporters must contact the Ministry to ensure if they need an export authorisation for their product and, if necessary, obtain an export authorisation. The authorisation must be presented to Finnish Customs when lodging the export declaration. The Customs is responsible for supervising that the exporter has the relevant authorisation to export the goods and that the goods are the ones mentioned in the authorisation. Goods cannot be exported before these checks have been done. 

Customs takes care of a smooth export procedure and of risk-based monitoring. Customs also monitors the implementation of the Regulation of the European Commission as part of the EU Customs Union and control of the EU’s external border.

The text of the Regulation is available on the website of the European CommissionLink to another website.(Opens New Window)

Inquiries: 
Tuuli-Maria Aalto, Director, Market Access Unit, (legislation), tel. +358 295 350633
Teemu Sepponen, Director, Export Control Unit, (application of authorisations), tel. +358 50 449 1445
Mikko Grönberg, Director of Customs Enforcement, Finnish Customs, (export of goods), tel. +358 40 332 2679