COVID-19 – Vaccines subject to export authorisation
Date : 16 March 2021
Mirroring the commission implementing regulation (EU) 2020/568 which aimed to prevent shortages and delayed deliveries of certain medical equipment in light of the critical situation of COVID-19 by making them subject to export authorisation, the commission implementing regulation (EU) 2021/111 extended by the regulation (EU) 2021/242 of March 11, 2021 imposes, from its date of publication of January 30, 2021 until June 30, 2021, an export authorisation for vaccines against SARS-related coronaviruses falling under the CN code 3002 20 10.
The original date of March 31, 2021 (assumed to be the date of full production capacity of COVID-19 vaccines in the EU) had to be postponed to June 31, 2021 with Regulation (EU) 2021/242 due to persistent delays in some of the deliveries of vaccines to the EU.
Additional codes were created to identify manufacturers:
– 4500 – Astra Zeneca AB
– 4501 – Pfizer / BioNtech
– 4502 – Moderna Switzerland / Moderna Inc
– 4503 – Janssen Pharmaceutica NV
– 4504 – CureVac AG
– 4504 – Sanofi Pasteur / Glaxosmithkline Biologicals S.A
– 4506 – Novavax
– 4999 – Others
Export authorization must be requested from the SBDU by completing the C089 document.
Exemptions from the license exist (Y089) for the following cases (art 1§5 of regulation 2021/111 and at 1§9 of regulation 2021/442):
– Donation or resale
– Emergency humanitarian intervention
– Overseas countries and territories of one of the Member States
– Countries of the AMC COVAX
The authorities in charge of delivering the authorisations have four (4) working days to issue a decision. If there is no response, the authorisation is deemed to be refused.
In France, the SBDU (Service des Biens à Double Usage) has been recognized by decree n°2021-162 of February 15, 2021 as the competent authority to process export applications for the export of vaccines.
For any request, exporters are invited to contact the SBDU directly by email at email@example.com.
– Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation
– Commission Implementing Regulation (EU) 2021/111 of 29 January 2021 making the exportation of certain products subject to the production of an export authorisation
– Decree n°2021-162 of February 15, 2021 modifying decree n°2020-74 of January 31, 2020 relating to the national service called “dual-use goods service”), JORF n°0040 of February 16, 2021, text n°9.
– Notice of 15 February 2021 to operators concerning exports of vaccines as described in Annex I of Commission implementing regulation (EU) 2021/111 of 20 January 2021, JORF n°0040 of 16 February 2021, text n°101.