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Commission Implementing Decision (EU) 2022/1516 of 8 September 2022 amending Implementing Decision (EU) 2021/1073 laying down technical specifications and rules for the implementation of the trust framework for the EU Digital COVID Certificate established by Regulation (EU) 2021/953 of the European Parliament and of the Council (Text with EEA relevance)

Implementing Decision (EU) 2022/1516 · Decision · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Implementing Decision (EU) 2021/1073 is amended as follows: (1) Annex II is amended in accordance with Annex I to this Decision; (2) Annex V is amended in accordance with Annex II to this Decision.

Article 2

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This Decision shall enter into force on the third day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEX ISupplementary provisions

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ANNEX I Annex II to Implementing Decision (EU) 2021/1073 is amended as follows: (1) in the introductory section, the first sentence of the sixth paragraph shall be replaced by the following: ‘As some value sets based on the coding systems provided for in this Annex, such as those for vaccine and antigen test coding, are changing often, they shall be published and regularly updated by the Commission with the support of the eHealth Network and the Health Security Committee.’; (2) in Section 3, the following paragraphs are added: ‘If a country using the EU Digital COVID Certificate (“EU DCC”) decides to issue vaccination certificates to clinical trial participants during ongoing clinical trials, the vaccine medicinal product shall be coded following the pattern CT_ clinical-trial-identifier Where the clinical trial has been registered in the EU Clinical Trials Register (EU-CTR), the clinical trial identifier from this register shall be used. In other cases, identifiers from other registers (such as clinicaltrials.gov or Australian New Zealand Clinical Trials Registry) may be used. The clinical trial identifier shall include a prefix allowing the identification of the clinical trial register (such as EUCTR for EU Clinical Trials Register, NCT for clinicaltrials.gov, ACTRN for Australian New Zealand Clinical Trials Registry). Where the Commission has received guidance from the Health Security Committee, the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA) with regard to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials, the guidance shall be published either as part of the value sets document or separately.’; (3) in Section 4, the following paragraph is added: ‘If a country using EU DCC decides to issue vaccination certificates to clinical trial participants during ongoing clinical trials, the vaccine marketing authorization holder or manufacturer shall be coded using the value designated to it in the value set, if available. In other cases, the vaccine marketing authorization holder or manufacturer shall be coded using the rule described under Section 3 Vaccine medicinal product (CT_ clinical-trial-identifier ).’; (4) in Section 7, the following paragraph is added: ‘The code LP217198-3 (Rapid immunoassay) shall be used to indicate both rapid antigen tests and laboratory-based antigenic assays.’; (5) in Section 8, the first sentence of the second paragraph shall be replaced by the following: ‘The content of the value set shall include the selection of antigen test as listed in the common and updated list of COVID-19 antigen tests, established on the basis of Council Recommendation 2021/C 24/01 and agreed by the Health Security Committee. The list is maintained by the JRC in the COVID-19 In Vitro Diagnostic Devices and Test Methods Database at: https://covid-19-diagnostics.jrc.ec.europa.eu/devices/hsc-common-recognition-rat’.

ANNEX IISupplementary provisions

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ANNEX II Section 4 of Annex V to Implementing Decision (EU) 2021/1073 is amended as follows: (1) in point 4.1, the table is amended as follows: (a) in the third row (field ‘v/mp’, field name ‘COVID-19 vaccine product’), the second sentence under the column ‘Instructions’ is replaced by the following: ‘A coded value from the value set vaccine-medicinal-product.json or a coded value referring to a clinical trial and following the rule defined in Section 3 of Annex II.’; (b) in the fourth row (field ‘v/ma’, field name ‘COVID-19 vaccine marketing authorisation holder or manufacturer’), the second sentence under the column ‘Instructions’ is replaced by the following: ‘A coded value from the value set vaccine-mah-manf.json or a coded value referring to a clinical trial and following the rule defined in Section 4 of Annex II.’; (2) in point 4.2, the table is amended as follows: (a) in the third row (field ‘t/nm’, field name ‘Test name (nucleic acid amplification tests only)’), the third paragraph under the column ‘Instructions’ is replaced by the following: ‘For antigen test: the field shall not be used, as the name of the test is supplied indirectly through the test device identifier (t/ma).’; (b) the fourth row is replaced as follows: ‘ t/ma Test device identifier (antigen tests only) Antigen test device identifier from the JRC database. Value set (HSC common list): — All antigen tests in HSC common list (human readable). — https://covid-19-diagnostics.jrc.ec.europa.eu/devices/hsc-common-recognition-rat (machine-readable, values of the field id_device included on the list form the value set). In EU/EEA countries, issuers shall only issue certificates for tests belonging to the currently valid value set. The value set shall be updated every 24 hours. Values outside of the value set may be used in certificates issued by third countries, however the identifiers shall still be from the JRC database. The use of other identifiers such as those provided directly by test manufacturers is not permitted. Verifiers shall detect values not belonging to the up to date value set and display certificates bearing these as invalid. If an identifier is removed from the value set, certificates including it may be accepted for a maximum of 72 hours after the date of removal. The value set is distributed from the EUDCC Gateway. For antigen test: exactly 1 (one) non-empty field shall be provided. For NAAT: the field shall not be used, even if the NAA test identifier is available in the JRC database. Example: “ma”: “344”(SD BIOSENSOR Inc, STANDARD F COVID-19 Ag FIA)’; (c) in the seventh row (field ‘t/tc’, field name ‘Testing centre or facility’), the third paragraph under the column ‘Instructions’ is replaced by the following: ‘For antigen test: the field is optional. If provided, it shall not be empty.’; (3) in point 4.3, in the table, the second row (field ‘r/fr’), the word ‘NAAT’ is deleted from the columns ‘Field name’ and ‘Instructions’.

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Political and Security Committee Decision BiH/15/2009 of 11 November 2009 on the appointment of an EU Force Commander for the European Union military operation in Bosnia and Herzegovina 2009/832/EC: Council Decision of 10 November 2009 on the procedure concerning derogations from the rules of origin set out in the Origin Protocols annexed to Economic Partnership Agreements with ACP States, and repealing Decision 2000/399/EC 2009/833/EC: Commission Decision of 10 November 2009 adjusting the weightings applicable from 1 August 2008 , 1 September 2008 , 1 October 2008 , 1 November 2008 , 1 December 2008 and 1 January 2009 to the remuneration of officials, temporary staff and contract staff of the European Communities serving in third countries Council Decision of 10 November 2009 on the conclusion of an Agreement in the form of a Protocol between the European Community and the Republic of Tunisia establishing a dispute settlement mechanism applicable to disputes under the trade provisions of the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Republic of Tunisia, of the other part Council Decision of 10 November 2009 on the conclusion of an Agreement in the form of a Protocol between the European Community and its Member States and the Republic of Lebanon establishing a dispute settlement mechanism applicable to disputes under the trade provisions of the Euro-Mediterranean Agreement establishing an association between the European Community and its Member States, of the one part, and the Republic of Lebanon, of the other part 2011/348/EC: Council Decision of 10 November 2009 on the signing, on behalf of the Community, and provisional application of the Agreement between the European Community and the Hashemite Kingdom of Jordan on Scientific and Technological Cooperation 2009/828/EC: Commission Decision of 3 November 2009 relating to the draft Regional Legislative Decree declaring the Autonomous Region of Madeira to be an Area Free of Genetically Modified Organisms, notified by the Republic of Portugal pursuant to Article 95(5) of the EC Treaty (notified under document C(2009) 8438) (Text with EEA relevance)2009/813/EC: Commission Decision of 30 October 2009 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 (MON-89Ø34-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2009) 8383) (Text with EEA relevance)2009/814/EC: Commission Decision of 30 October 2009 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 (MON-88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2009) 8384) (Text with EEA relevance)2009/799/EC: Commission Decision of 29 October 2009 amending Decision 2002/994/EC concerning certain protective measures with regard to the products of animal origin imported from China (notified under document C(2009) 8243) (Text with EEA relevance)Commission Decision of 29 October 2009 on the adoption of basic parameters for registers of train driving licences and complementary certificates provided for under Directive 2007/59/EC of the European Parliament and of the Council (notified under document C(2009) 8278) (Text with EEA relevance)Commission Decision of 28 October 2009 concerning the aid granted by Italy for the restructuring of cooperatives in the fisheries sector and of their consortia (State aid C 29/06) (notified under document C(2009) 8040) (Text with EEA relevance)

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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