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Document 02021R0442-20210701
Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation
Consolidated text: Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation
Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation
02021R0442 — EN — 01.07.2021 — 001.001
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation (OJ L 085 12.3.2021, p. 190) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1071 of 29 June 2021 |
L 230 |
28 |
30.6.2021 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/442
of 11 March 2021
making the exportation of certain products subject to the production of an export authorisation
Article 1
Export authorisation
An export authorisation established in accordance with the form set out in Annex I shall be required for the export of the following goods:
vaccines against SARS-related coronaviruses (SARS-CoV species) currently falling under CN code 3002 20 10 , irrespective of their packaging;
active substances, including master and working cell banks used for the manufacture of such vaccines, currently falling under CN codes ex 2933 99 80 , ex 2934 99 90 , ex 3002 90 90 and ex 3504 00 90 .
For the purposes of this Regulation, ‘export’ means:
an export of Union goods under the export procedure within the meaning of Article 269(1) of Regulation (EU) No 952/2013 of the European Parliament and of the Council ( 1 );
a re-export of non-Union goods within the meaning of Article 270(1) of that Regulation after such goods have been subject to manufacturing operations including filling and packaging within the customs territory of the Union.
The following exports shall not be subject to the export authorisation provided for in this Article:
exports to Albania, Andorra, Bosnia and Herzegovina, the Faroe Islands, Iceland, Kosovo ( *1 ), Liechtenstein, Montenegro, Norway, North Macedonia, San Marino, Serbia, Switzerland, Vatican City, the overseas countries and territories listed in Annex II to the Treaty on the Functioning of the European Union, Büsingen, Helgoland, Livigno, Ceuta and Melilla, Algeria, Armenia, Azerbaijan, Belarus, Egypt, Georgia, Israel, Jordan, Lebanon, Libya, Moldova, Morocco, Palestine ( *2 ), Syria, Tunisia, and Ukraine;
exports to low- and middle-income countries in the COVAX AMC list ( 2 );
exports of goods purchased or delivered through COVAX, Unicef and PAHO with destination to any other COVAX participating country;
exports of goods purchased by Member States under the APAs entered into by the Union and donated or resold to a third country;
exports in the context of a humanitarian emergency response;
exports to facilities located on the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to UNCLOS.
For exports referred to in point (f) of the first subparagraph, the export declaration shall provide the information about the continental shelf or exclusive economic zone of the Member State to which the goods covered by this Regulation are to be brought by using the relevant additional reference code as defined in data element 2/3 in point 2 of Title II of Annex B to Commission Implementing Regulation (EU) 2015/2447 ( 3 ).
Article 2
Procedure
Article 3
Notifications
These notifications shall contain the following information:
name and contact details of the competent Authority;
identity of the applicant;
destination country;
acceptance or refusal to grant the export authorisation;
commodity code;
quantity expressed in number of vaccine doses;
units and description of the goods;
information on the number of vaccine doses of goods covered by this Regulation distributed in the Union since 1 December 2020 broken down by Member State in which the vaccines were distributed.
The notification shall be submitted to the following email address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu
Article 4
Entry into force and application
This Regulation shall enter into force on 13 March 2021.
It shall apply until 30 September 2021.
Export authorisations issued in accordance with Annex I to Implementing Regulation (EU) 2021/111 shall remain valid after the entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
Model for export authorisation forms referred to in Article 1
Member States shall ensure the visibility of the nature of the authorisation on the form issued. The export authorisation shall be valid in all Member States of the European Union until its expiry date.
EUROPEAN UNION Export of COVID-19 vaccines and active substances including master and working cell banks (Regulation (EU) 2021/442) |
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1. Authorisation holder (EORI number if applicable) and TARIC additional code |
2. Authorisation number |
3. Expiry date |
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4. Issuing authority |
5. Customs office of export |
6. Destination country |
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7. Commodity code |
8. Quantity |
9. Unit |
10. Description of the goods |
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11. Location |
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7. Commodity code |
8. Quantity |
9. Unit |
10. Description of the goods |
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11. Location |
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7. Commodity code |
8. Quantity |
9. Unit |
10. Description of the goods |
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11. Location |
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7. Commodity code |
8. Quantity |
9. Unit |
10. Description of the goods |
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11. Location |
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12. Signature, place and date, stamp |
Explanatory notes to the export authorisation form.
The completion of all the boxes is mandatory except when stated otherwise.
Boxes 6 to 10 are repeated 4 times to allow requesting an authorisation for 4 different products.
Box 1 |
Authorisation holder |
Full name and address of the company for whom the authorisation is issued + EORI number if applicable. TARIC additional code as defined in Annex II. |
Box 2 |
Authorisation number |
The authorisation number is completed by the authority issuing the export authorisation and has the following format: XXyyyy999999, where XX is the 2-letter geonomenclature code (1) of the issuing Member State, yyyy is the 4-digit year of issuance of the authorisation, 999999 is a 6-digit number unique within XXyyyy and attributed by the issuing authority. |
Box 3 |
Expiry date |
The issuing authority can define an expiry date for the authorisation. This expiry date cannot be later than 30 June 2021. If no expiry date is defined by the issuing authority, the authorisation expires at the latest on 30 June 2021. |
Box 4 |
Issuing authority |
Full name and address of the Member State authority that issued the export authorisation. |
Box 5 |
Customs office of export |
The full name and Union code of the customs office of where the export declaration is lodged. |
Box 6 |
Destination country |
2-letter geonomenclature code of the country of destination of the goods for which the authorisation is issued. |
Box 7 |
Commodity code |
The numerical code from the Harmonised System or the Combined Nomenclature (2) under which the goods to export are classified when the authorisation is issued. |
Box 8 |
Quantity |
The quantity of goods measured in the unit declared in box 9. |
Box 9 |
Unit |
The measurement unit in which the quantity declared in box 8 is expressed. The units to use are number of vaccine doses. |
Box 10 |
Description of the goods |
Plain language description precise enough to allow identification of the goods. |
Box 11 |
Location |
The geonomenclature code of the Member State where the goods are located. If the goods are located in the Member State of the issuing authority, this box must be left empty. |
Box 12 |
Signature, stamp, place and date, |
The signature and stamp of the issuing authority. The place and the date of issuance of the authorisation. |
(1)
Commission Implementing Regulation (EU) 2020/1470 of 12 October 2020 on the nomenclature of countries and territories for the European statistics on international trade in goods and on the geographical breakdown for other business statistics (OJ L 334, 13.10.2020, p. 2).
(2)
Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1). |
ANNEX II
Taric additional codes
Company |
Taric additional code for vaccines against SARS-related coronaviruses (SARS-CoV species) |
Taric additional code for active substances (1) |
AstraZeneca AB |
4500 |
4520 |
Pfizer/BioNTech |
4501 |
4521 |
Moderna Switzerland/Moderna Inc |
4502 |
4522 |
Janssen Pharmaceutica NV |
4503 |
4523 |
CureVac AG |
4504 |
4524 |
Sanofi Pasteur/GlaxoSmithKline Biologicals S.A |
4505 |
4525 |
Novavax |
4506 |
4526 |
Other manufacturers |
4999 |
4999 |
(1)
Active substances including master and working cell banks used for the manufacture of vaccines against SARS-related coronaviruses (SARS-CoV species). |
Company |
TARIC additional code for other substances (1) |
All manufacturers |
4599 |
(1)
‘Other substances’ are products or substances that are not going to be used to manufacture vaccines against SARS-related coronaviruses (SARS-CoV species), but that are classified under the same CN codes as the active substances. |
( 1 ) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).
( *1 ) This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.
( *2 ) This designation shall not be construed as recognition of a State of Palestine and is without prejudice to the individual positions of the Member States on this issue.
( 2 ) https://www.gavi.org/news/media-room/92-low-middle-income-economies-eligible-access-covid-19-vaccines-gavi-covax-amc
( 3 ) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558).