ANNEX ISupplementary provisions
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’.