In January 2021, the European Union announced the establishment of a transparency and export authorisation scheme for COVID-19 vaccines.



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EUR-Lex. Official gazette. “Commission Implementing Regulation (EU) 2021/111 of 29 January 2021 making the exportation of certain products subject to the production of an export authorisation”. 30/01/2021. Available at:

European Commission. Press release. “€Commission puts in place transparency and authorisation mechanism for exports of COVID-19 vaccines”. 29/01/2021. Available at:

European Commission. Questions and Answers: Transparency and authorisation mechanism for exports of COVID-19 vaccines. Available at:

European Commission. Questions and Answers: COVID-19 vaccination in the EU*. Available at:

International Chamber of Commerce. News. "ICC raises concern over proposed EU export curbs on Covid-19 vaccines". 29/01/2020. Available at:

Financial Times. "Italy blocks shipment of Oxford/AstraZeneca vaccines to Australia". 04/03/2021. Available at:

EUR-Lex. Official gazette. “Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation”. 12/03/2021. Available at:

Reuters. "Exclusive: EU blocks export of 3.1 million doses of AstraZeneca's new crown vaccine to Australia-source". 06/04/2021. Available at:

Update June 2021

EUR-Lex. Official Gazette. Commission Implementing Regulation (EU) 2021/1071 of 29 June 2021 amending Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 related to the mechanism making certain products subject to the production of an export authorisation. 30/06/2021. Available at:

Inception date: 30 Jan 2021 | Removal date: 25 Mar 2021

Export licensing requirement

On 30 January 2021, the EU adopted Commission Implementing Regulation (EU) 2021/111  that establishes a temporary export authorisation mechanism for the export of COVID-19 vaccines from certain producers. The export authorisation mechanism is in place until 31 March 2021. The affected HS-code is 3002.20.10.

The objective of the mechanism is to ensure timely access to COVID-19 vaccines for EU citizens and to increase transparency in the export operations of pharmaceuticals. The measure establishes an export authorisation scheme for vaccines produced by companies that already have Advanced Purchase Agreements (APA) with the EU. Moreover, these pharmaceuticals also have to detail their vaccine exports over the past three months. As per Article 1, the condition to authorising the export operation is the following: “the competent authority shall deliver an export authorisation only where the volume of exports is not such that it poses a threat to the execution of Union APAs concluded with vaccines manufacturers”.

In this context, the Commission noted in a press release: "The Commission has invested large amounts in the development of the production capacity of vaccine developers in the EU. This with the aim to ensure quicker delivery of vaccines to the European citizens, support planning and vaccination strategies with the ultimate goal to protect public health. It is therefore reasonable for the EU to monitor how the funds disbursed under the Advance Purchase Agreements (APA) have been used, especially in a context of potential shortages of essential COVID-19 vaccines. The main purpose is to offer public transparency to the European citizens. The transparency and authorisation system will require companies to notify the Member State authorities about the intention to export vaccines produced in the European Union."

According to the EU, as of 1 February 2021, the pharmaceuticals covered by this mechanism having concluded APAs are BioNTech-Pfizer, Moderna, CureVac, AstraZeneca, Sanofi-GSK, and Johnson and Johnson. 

Several territorial exceptions were also provided in Article 5, which, according to the EU, are provided in honour to the principle of solidarity and with the objective of not affecting the EU’s commitments towards low- and middle-income countries.


On 4 March 2021, Italy, backed by the European Commission, denied the export authorisation for a batch of 250 000 doses of the AstraZeneca vaccine. In this sense, they effectively blocked the export of vaccines that were destined for Australia. This represents the first use of the aforementioned mechanism. 

On 12 March 2021, the European Commission adopted Commission Implementing Regulation (EU) 2021/442 that extends the present measure until 30 June 2021, as well as add new HS codes to the scheme (see related state act).

On 25 March 2021, the EU adopted Commission Implementing Regulation (EU) 2021/442 that modifies the temporary export scheme (see related state act).