02021R0442 — EN — 01.10.2021 — 002.001

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Amended by:









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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







Article 1

Export authorisation

1. An export authorisation established in accordance with the form set out in Annex I shall be required for the export of the following goods: (a) vaccines against SARS-related coronaviruses (SARS-CoV species) currently falling under CN code 3002 20 10 , irrespective of their packaging; (b) 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 .

2. For the purposes of this Regulation, ‘export’ means: (a) 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 ); (b) 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.

3. The export authorisation shall be produced when the goods are declared for export and at the latest at the moment of the release of the goods.

4. The export authorisation shall be granted by the competent authorities of the Member State where products covered by this Regulation are manufactured and shall be issued in writing or by electronic means. For the purposes of this Regulation, manufacturing shall include the filling and packaging of vaccines. If the goods covered by this Regulation are manufactured outside the Union, the export authorisation shall be granted by the competent authorities of the Member State where the exporter is established.

5. The export or re-export declaration shall indicate the number of doses (in case of multi-dose containers, the number of doses for adults).

6. Without the production of a valid export authorisation, the exportation of the goods covered by this Regulation shall be prohibited.

7. The competent authority shall grant an export authorisation, unless it poses a threat to the execution of APAs concluded by the Union with vaccine manufacturers, in view of the volume of exports or any other relevant circumstances.

8. An export authorisation may cover one shipment with more than one consignment of goods mentioned in paragraph 1, provided all consignments are destined to the same destination country and released by the same customs office of export.

9. The following exports shall not be subject to the export authorisation provided for in this Article: (a) 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; (b) exports to low- and middle-income countries in the COVAX AMC list ( 2 ); (c) exports of goods purchased or delivered through COVAX, Unicef and PAHO with destination to any other COVAX participating country; (d) exports of goods purchased by Member States under the APAs entered into by the Union and donated or resold to a third country; (e) exports in the context of a humanitarian emergency response; (f) 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

1. The request for export authorisation shall contain the information set out in Annex I and the applicable TARIC additional codes in Annex II. In addition it shall also contain 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 as well as information on the number of vaccine doses of goods covered by this Regulation distributed in Northern Ireland since the entry into force of Implementing Regulation (EU) 2021/111.

2. The competent authorities of the Member States shall process the requests for export authorisations as soon as possible, and shall issue a draft decision no later than two working days from the date on which all required information has been provided to them by the applicant. Under exceptional circumstances and for duly justified reasons, that period may be extended by a further period of two working days.

3. The competent authorities of the Member States shall immediately notify the request and the draft decision to the Commission at the following email address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu

4. Where the Commission disagrees with the draft decision notified by a Member State, it shall issue an opinion to the competent authority within one working day from receipt of a notification. If the request is incomplete or inaccurate, that time period shall start from the moment when the required information is provided, at the request of Commission, by the competent authority of the notifying Member State. The Commission shall evaluate the impact of exports for which an authorisation is requested on the execution of the relevant APAs with the Union. The Member State shall expeditiously decide on the request for authorisation in accordance with the Commission’s opinion.

5. The vaccine manufacturers that have concluded APAs with the Union shall provide the relevant data concerning their exports since 30 October 2020, together with the first request for authorisation under this Regulation or under Implementing Regulation (EU) 2021/111 to the Commission (at the following email address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu) and to the authorities of the competent Member State. That information shall include the volume of exports of COVID-19 vaccines, the final destination and final recipients and a precise description of the products. The absence of such information may lead to refusal of export authorisations.

6. The competent authorities of the Member States may decide to make use of electronic documents for the purpose of processing requests for export authorisations.

7. The competent authorities of the Member States may verify the information submitted pursuant to paragraph 6 on the premises of the applicant, even after the authorisation has been granted.

Article 3

Notifications

1. Member States shall immediately notify the Commission of the export authorisations granted and those refused.

2. These notifications shall contain the following information: (a) name and contact details of the competent Authority; (b) identity of the applicant; (c) destination country; (d) acceptance or refusal to grant the export authorisation; (e) commodity code; (f) quantity expressed in number of vaccine doses; (g) units and description of the goods; (h) 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

3. The Commission shall make the information on the export authorisations granted and refused publicly available, due account being taken of the confidentiality of the data submitted.

Article 4

Entry into force and application

This Regulation shall enter into force on 13 March 2021.

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It shall apply until 31 December 2021.

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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) 1. Authorisation holder (EORI number if applicable) and TARIC additional code 2. Authorisation number 3. Expiry date 4. Issuing authority 5. Customs office of export 6. Destination country 7. Commodity code 8. Quantity 9. Unit 10. Description of the goods 11. Location 7. Commodity code 8. Quantity 9. Unit 10. Description of the goods 11. Location 7. Commodity code 8. Quantity 9. Unit 10. Description of the goods 11. Location 7. Commodity code 8. Quantity 9. Unit 10. Description of the goods 11. Location 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.