ANNEX IISupplementary provisions
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’.