ANNOUNCED AS TEMPORARYYes
Export licensing requirement
On 12 March 2021, the EU adopted Commission Implementing Regulation (EU) 2021/442 that modifies and extends the temporary export authorisation mechanism for the export of COVID-19 vaccines from certain producers put in place in January 2021 (see related state act). Importantly, the modification precise the active substances also subject to the export authorisation mechanism by adding new HS codes.
The measure specifies that the affected HS-code for Covid-19 vaccines is 3002.20.10 (see related state act), while for active substances (including cell banks used for producing the vaccines) are 2933.99. 80, 2934.99.90, 3002.90.90, and 3504.00.90.
Recall 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. According to the press release, the pharmaceuticals covered by this mechanism having concluded APAs are BioNTech-Pfizer, Moderna, CureVac, AstraZeneca, Sanofi-GSK, and Johnson and Johnson.
In this context, the Commissioner for Health and Food Safety, Stella Kyriakides, highlighted that they "expect companies with which we have signed a contract to fulfil their obligations towards EU citizens".
The various territorial exceptions still apply, 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.
The measure entered into force on 13 March 2021 and shall be in place until 30 June 2021.
On 25 March 2021, the EU adopted Commission Implementing Regulation (EU) 2021/442 that modifies the temporary export scheme (see related state act).
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