(1)

On 30 January 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/111 (2) making the exportation of COVID-19 vaccines as well as active substances, including master and working cell banks, used to manufacture these vaccines, subject to the production of an export authorisation, pursuant to Article 5 of Regulation (EU) 2015/479. Implementing Regulation (EU) 2021/111 applies for a maximum period of six weeks.

(2)

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.

(3)

In light of the critical situation of COVID-19 vaccines in the Union, and in particular the risk that vaccines produced or packaged in the Union are exported, especially to non-vulnerable countries, in potential breach of contractual commitments entered into by the pharmaceutical industries, continued protective measures are warranted to prevent shortages and delayed deliveries of such vaccines. It is therefore in the Union’s interest to maintain, for a limited period of time, a mechanism to ensure that exports of COVID-19 vaccines covered by APAs with the Union are subject to a prior authorisation, so that there are adequate supplies in the Union to meet the vital demand, but without impacting on the Union’s international commitments in this respect.

(4)

Export authorisations should be granted by the Member States where products covered by this Regulation are manufactured to the extent that the exports concerned do not pose a threat to the continuous supply of the vaccines necessary for the execution of the APAs between the Union and vaccine manufacturers in view of their volume or other relevant circumstances. In order to ensure a coordinated approach at Union level, the Member States should seek the opinion of the Commission in advance and decide in accordance with that opinion.

(5)

The administrative modalities for the export authorisations should be left to the discretion of the Member States during the period of application of this temporary mechanism.

(6)

An export authorisation may cover multiple export consignments of vaccines and samples. In order to facilitate the administration process while ensuring transparency, the authorisation form should be simplified, allowing that one single request and authorisation form cover one shipment with consignments to multiple final recipients within the same destination country but being released by the same customs office of export. For customs control purposes, the customs office of export should be indicated in the authorisation.

(7)

To ensure that the situation is assessed at regular intervals, and in order to ensure transparency and consistency, Member States should provide information to the Commission on requested export authorisations, and their decisions in response to such requests. The Commission should make such information publicly available on a regular basis, due account being taken of their confidential nature.

(8)

The single market for medicinal products is closely integrated beyond the boundaries of the Union, and so are its supply chains and distribution networks. This is particularly the case with regard to the neighbouring countries and economies, the Member States of the European Free Trade Area and the Western Balkans, which are engaged in the process of integration with the Union. Subjecting exports of COVID-19 vaccines to those countries to an export authorisation requirement would be counterproductive due to their proximity and dependency on Union supplies of vaccines (most of them do not have their own production capacity for the vaccines in question in adequate quantities) and the fact that vaccines are an essential product necessary to prevent the further spreading of the pandemic. It is therefore appropriate to exempt such countries from the scope of application of this Regulation.

(9)

It is likewise appropriate to exempt from the export authorisation requirement the overseas countries and territories listed in Annex II to the Treaty, the Faeroe Islands, Andorra, San Marino, and the Vatican City, as well as territories of Member States specifically excluded from the customs territory, namely Büsingen, Helgoland, Livigno, Ceuta and Melilla, since they have a particular dependency on the metropolitan supply chains of the Member States to which they are attached or on the supply chains of neighbouring Member States, respectively. Likewise, exports to the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to United Nations Convention on the Law of the Sea (UNCLOS) should be exempted from the application of this Regulation.

(10)

As only exports from the customs territory of the Union are covered, countries that form part of that customs territory need not to be exempted in order to receive unrestricted shipments from within the Union. This is the case notably for the Principality of Monaco (3).

(11)

Based on the principle of international solidarity, exports to enable the provisions of supplies in the context of humanitarian emergency response, exports to the COVAX facilities, and in particular to low and middle-lower income countries, given their vulnerability and limited access to vaccines, exports of COVID-19 vaccines purchased or delivered through COVAX, Unicef and PAHO with destination to any other COVAX participating country and exports of COVID-19 vaccines purchased by Member States under the Union’s APAs and resold or donated to a third country should be exempted from the export authorisation requirement.

(12)

Prior authorisation requirements are of an exceptional nature, and should be targeted and of a limited duration. Given the continuing constraints on vaccine production and risks of delays in the delivery of COVID-19 vaccines in the Union, as mentioned in recitals 2 and 3, the export authorisation mechanism should continue to apply for a limited time period.

(13)

Due to the limited duration of the measures provided for in Implementing Regulation (EU) 2021/111, this Regulation should enter into force as soon as possible.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 3(1) of Regulation (EU) 2015/479,