ANNOUNCEMENT 12 Mar 2021

In March 2021, the European Union announced the modification and extension of the transparency and export authorisation scheme for COVID-19 vaccines put in place in January 2021 (see related state act).

NUMBER OF INTERVENTIONS

1

  • 1 harmful
  • 0 neutral
  • 0 liberalising

SOURCE

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: https://eur-lex.europa.eu/eli/reg_impl/2021/442/oj

European Commission. Press release. “Commission extends transparency and authorisation mechanism for exports of COVID-19 vaccines”. 11/03/2021. Available at: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_1121

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: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.230.01.0028.01.ENG&toc=OJ%3AL%3A2021%3A230%3ATOC

Update September 2021

EUR-Lex. Official Gazette. Commission Implementing Regulation (EU) 2021/1728 of 29 September 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. 30/09/2021. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.345.01.0034.01.ENG&toc=OJ%3AL%3A2021%3A345%3ATOC

Inception date: 13 Mar 2021 | Removal date: 25 Mar 2021

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. 

Update

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

AFFECTED SECTORS