Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Following the publication of version 2.0 in February 2021, the content of this document was amended to:
• Include minor general updates to improve the quality of the EU IGUpdate the user guidance
• Update the provenance resource
• Updated Figure 1 and contents in user guidance
• Added new data elements to PMS data model [i.e. 1.13.1 Genetically Modified Organisms (GMOs); 1.18.1.1. Identifier value; 1.18.1.2. Identifier system; 1.18.2.1 Identifier value; 1.18.2.2. Identifier system; 4.5.5. Risk of supply shortage; 4.5.6. Risk of supply shortage comment; 4.5.7. Status reasons; 4.5.7.1. Reason; 4.5.7.2. Restore date; 4.10.5.1. Language; 5.2 Origin of the substance; 5.3 Composition grouping description; 5.5.4. (Certificate) master file; 5.5.4.1. File type; 5.5.4.2. File code; 5.5.4.3 Submission date; 5.5.4.4. Date of last update; 5.5.4.5. Manufacturer; 6.1.1. Language;]
• Updated technical information on conformance, data type, value, conformance, ISO/FHIR elements name/paths and FHIR Complementary Information across the guidance, where applicable
• Updated numbering of figures
• Added Annex II – Common/Euro…