On 29 January 2021, finding itself in a situation where the production and delivery of vaccines are still in a ramp-up phase, resulting in a temporary global shortage, the European Commission published Implementing Regulation (EU) 2021/111 making the export of certain products subject to an export authorisation.
According to Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation, it is important to maintain the protective measures until 30 June 2021 as the production capacity of COVID-19 vaccines is still in the building-up phase and remains, for certain vaccine manufacturers, below the pledged quantities to be destined for the Union on the basis of Advanced Purchased Agreements (APAs) concluded with the Union, and taking into account in particular the risk that vaccines produced or packaged in the Union are exported, especially to non-vulnerable countries, in potential breach of the contractual commitments made by the pharmaceutical industries.
The products for which an authorisation must be applied for in the Member State in which these products are manufactured are the following:
The authorisation must be presented when the goods are declared for export, but at the latest when the goods are released.
The export of such products is prohibited without a valid export authorisation.
No authorisation is required for exports to the following destinations:
No authorisation is required for the following transactions:
Vaccine manufacturers with Advanced Purchased Agreements shall provide to the Commission (email address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu) and to the OCEIT (email address: email@example.com) the relevant data concerning their exports since 30 October 2020, together with the first application for authorisation.
This notification must include the following information:
Failure to provide this information may result in export authorisations being refused.
The decision to grant an authorisation is subject to the condition that the volume of exports is not such that it poses a threat to the execution of advance purchase contracts concluded by the Union with vaccine manufacturers.
The applicant company will receive a decision on the granting of an export authorisation within 72 hours of the submission of a complete application. The application will be processed both by the Office for Export, Import and Transit Controls and by the European Commission within this time frame.
Biens de nature strictement civile – Vaccins contre les coronavirus du SARS – Exportation Demande d’autorisation