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)

• CELEX: Implementing Decision (EU) 2022/1516
• Articles: 4

Article 1

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

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

Schedules & Appendices

ANNEX I

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 II

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’.