IMPLEMENTATION LEVEL

Supranational

AFFECTED FLOW

Outflow

ANNOUNCED AS TEMPORARY

Yes

NON-TRADE-RELATED RATIONALE

No

ELIGIBLE FIRMS

firm-specific

JUMBO

No

TARIFF PEAK

No
← back to the state act
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 COUNTRIES

MAP
TABLE
EXPORT

AFFECTED SECTORS AND PRODUCTS

341 Basic organic chemicals
2933 Heterocyclic compounds with nitrogen heteroatom(s) only.
293399 Other
2934 Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds.
293499 Other
352 Pharmaceutical products
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micr
300290 Other
354 Chemical products n.e.c.
3504 Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed.
350400 Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed.

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