ANNEX ISupplementary provisions
ANNEX I ‘ANNEX II RULES FOR THE PURPOSE OF POPULATING THE EU DIGITAL COVID CERTIFICATE The general rules concerning the value sets established in this Annex aim to ensure interoperability on semantic level and shall allow uniform technical implementations for the EU Digital COVID Certificate. Elements contained in this Annex may be used for the three different settings (vaccination/testing/recovery), as provided for in Regulation (EU) 2021/953. Only elements with the necessity of semantic standardisation through coded value sets are listed in this Annex. Translation of the coded elements into the national language are under the responsibility of the Member States. For all data fields not mentioned in the following value set descriptions, encoding is described in Annex V. If for any reason the preferred code systems listed below cannot be used, other international code systems may be used and advice on how to map the codes from the other code system to the preferred code system shall be put in place. Text (display names) may be used in exceptional cases as a backup mechanism when a suitable code is not available in the defined value sets. Member States using other coding in their systems shall map such codes to the described value sets. Member States are responsible for any such mappings. As some value sets based on the coding systems provided for in this Annex, such as those for vaccine and rapid 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. The updated value sets shall be published on the relevant website of the Commission, as well as on the webpage of the eHealth Network. A history of changes shall be provided. 1. Disease or agent targeted/Disease or agent from which the holder has recovered: COVID-19 (SARS-CoV-2 or one of its variants) To be used in certificate 1, 2 and 3. The following code shall be used: Code Display Code System name Code System URL Code System OID Code System version 840539006 COVID-19 SNOMED CT http://snomed.info/sct 2.16.840.1.113883.6.96 2021-01-31 2. COVID-19 vaccine or prophylaxis Preferred Code System: SNOMED CT or ATC Classification. To be used in certificate 1. Examples of codes that shall be used from the preferred code systems are the SNOMED CT code 1119305005 (SARS-CoV-2 antigen vaccine), 1119349007 (SARS-CoV-2 mRNA vaccine) or J07BX03 (covid-19 vaccines). A value set setting out the codes to be used pursuant to the code systems established in this section shall be published and regularly updated by the Commission with the support of the eHealth Network. The value set shall be extended when new vaccine types are developed and put into use. 3. COVID-19 vaccine medicinal product Preferred Code Systems (in the order of preference): — Union Register of medicinal products for vaccines with EU-wide authorisation (authorisation numbers); — A global vaccine register such as one that could be established by the World Health Organisation; — Name of the vaccine medicinal product in other cases. If the name includes whitespaces, these shall be replaced by a hyphen (-). Name of the Value Set: Vaccine. To be used in certificate 1. An example of a code that shall be used from the preferred code systems is EU/1/20/1528 (Comirnaty). An example of the name of the vaccine to be used as a code: Sputnik-V (standing for Sputnik V). A value set setting out the codes to be used pursuant to the code systems established in this section shall be published and regularly updated by the Commission with the support of the eHealth Network. Vaccines shall be coded using an existing code in the published value set, even if their names are different in different countries. The reason is that there is no global vaccine registry covering all vaccines in current use yet. Example: — For the vaccine “COVID-19 Vaccine Moderna Intramuscular Injection”, which is the name of the Spikevax vaccine in Japan, use code EU/1/20/1507, as it is the name of this vaccine in the EU. If this is not possible or advisable in a specific case, a separate code will be provided in the published value set. 4. COVID-19 vaccine marketing authorisation holder or manufacturer Preferred Code System: — Organisation code from EMA (SPOR system for ISO IDMP); — A global vaccine marketing authorisation holder or manufacturer register, such as one that could be established by the World Health Organisation; — Name of the organisation in other cases. If the name includes whitespaces, these shall be replaced by a hyphen (-). To be used in certificate 1. An example of a code that shall be used from the preferred code system is ORG-100001699 (AstraZeneca AB). An example of the name of the organisation to be used as a code: Sinovac-Biotech (standing for Sinovac Biotech). A value set setting out the codes to be used pursuant to the code systems established in this section shall be published and regularly updated by the Commission with the support of the eHealth Network. Different branches of the same Marketing Authorisation Holder or the same manufacturer shall use an existing code in the published value set. As a general rule, for the same vaccine product, the code referring to its marketing authorisation holder in the EU shall be used, as there is no internationally agreed vaccine manufacturer or marketing authorisation holder registry yet. Examples: — For the organisation “Pfizer AG”, which is an MAH for vaccine “Comirnaty” used in Switzerland, use code ORG-100030215 referring to BioNTech Manufacturing GmbH, as it is the MAH of Comirnaty in the EU. — For the organisation “Zuellig Pharma”, which is an MAH for vaccine Covid-19 Vaccine Moderna (Spikevax) used in the Philippines, use code ORG-100031184 referring to Moderna Biotech Spain S.L., as it is the MAH of Spikevax in the EU. If this is not possible or advisable in a specific case, a separate code will be provided in the published value set. 5. Number in a series of doses as well as the overall number of doses in the series To be used in certificate 1. Two fields: (1) Number in a series of vaccine doses of a COVID-19 vaccine (N); (2) Overall number of doses in the vaccination series (C). 5.1. Primary vaccination series Where the person is receiving doses of the primary vaccination series, that is, the vaccination series intended to provide sufficient protection at an initial stage, (C) shall reflect the overall number of doses of the standard primary vaccination series (e.g. 1 or 2, depending on the type of vaccine administered). This includes the option of using a shorter series (C=1) where the vaccination protocol applied by a Member State provides for the administration of a single dose of a 2-dose vaccine to persons having previously been infected with SARS-CoV-2. A completed primary vaccination series shall thus be indicated by N/C = 1. For example: — 1/1 would indicate the completion of a primary single-dose vaccination course, or the completion of a primary course consisting of one dose of a 2-dose vaccine administered to a recovered person in line with the vaccination protocol applied by a Member State; — 2/2 would indicate the completion of a primary 2-dose vaccination series. Where the primary vaccination series is extended, for example for persons with severely weakened immune systems or where the recommended interval between primary doses has not been respected, any such doses shall be encoded as additional doses falling under Section 5.2. 5.2. Additional doses Where the person is receiving doses following the primary vaccination series, such additional doses (X) shall be reflected in the corresponding certificates by increases in the number of doses administered (N) and overall number of doses (C) (resulting in (N+X)/(C+X)). For example: — 2/2 would indicate the administration of an additional dose following a primary single-dose vaccination course, or the administration of an additional dose following the completion of a primary course consisting of one dose of a 2-dose vaccine administered to a recovered person in line with the vaccination protocol applied by a Member State; — 3/3 would indicate the administration of an additional dose following a primary 2-dose vaccination series. Additional doses administered after the completion of the primary vaccination series shall thus be indicated by (N+X)/(C+X) = 1. Vaccination certificates issued by 31 December 2021 shall continue to be accepted even if such certificates follow a different rule for encoding the number in a series of doses or the overall number of doses in the series. To ensure this, technical measures may be taken. Within the legal framework established by Regulation (EU) 2021/953, Member States may take measures to address the situation of vulnerable groups who may receive additional doses as a matter of priority. For example, if a Member State decides to administer additional doses only to specific sub-groups of the population, it can choose, in accordance with Article 5(1) of Regulation (EU) 2021/953, to issue vaccination certificates indicating the administration of such additional doses only upon request and not automatically. Where such measures are taken, Member States shall inform the persons concerned accordingly, as well as that they may continue to make use of the certificate received following the completing of the standard primary vaccination series. 6. Member State or third country in which the vaccine was administered/test was carried out Preferred Code System: ISO 3166 Country Codes. To be used in certificates 1, 2 and 3. Value set content: the complete list of 2-letter codes, available as a value set defined in FHIR (http://hl7.org/fhir/ValueSet/iso3166-1-2). If the vaccination or test was performed by an international organisation (such as UNHCR or WHO) and no information about the country is available, a code for the organisation shall be used. Such additional codes shall be published and regularly updated by the Commission with the support of the eHealth Network. 7. The type of test To be used in certificate 2, and certificate 3 if support for the issuance of recovery certificates based on types of test other than NAAT is introduced through a delegated act. The following codes shall be used. Code Display Code System name Code System URL Code System OID Code System version LP6464-4 Nucleic acid amplification with probe detection LOINC http://loinc.org 2.16.840.1.113883.6.1 2.69 LP217198-3 Rapid immunoassay LOINC http://loinc.org 2.16.840.1.113883.6.1 2.69 8. Manufacturer and commercial name of the test used (optional for NAAT test) To be used in certificate 2. The content of the value set shall include the selection of rapid antigen test as listed in the common and updated list of COVID-19 rapid 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 For this code system, relevant fields such as the identifier of the test device, name of the test and manufacturer shall be used, following the JRC structured format available at: https://covid-19-diagnostics.jrc.ec.europa.eu/devices 9. Result of the test To be used in certificate 2. The following codes shall be used: Code Display Code System name Code System URL Code System OID Code System version 260415000 Not detected SNOMED CT http://snomed.info/sct 2.16.840.1.113883.6.96 2021-01-31 260373001 Detected SNOMED CT http://snomed.info/sct 2.16.840.1.113883.6.96 2021-01-31' ’