Project Summary for ISO Identification of Medicinal Products (IDMP) Technical Specifications and EU/EMA Requirements for SPL Release 7
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Project Details
Number | 1147 View Ballot Items List (with NIBs) |
---|---|
Name | ISO Identification of Medicinal Products (IDMP) Technical Specifications and EU/EMA Requirements for SPL Release 7 |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | Orders and Observations Work Group |
Steering Division | Clinical |
Description | The scope of this project is to describe the use of SPL Release 7 as the data exchange format to support ISO IDMP Technical Specifications. The ISO IDMP Technical Specifications will describe data exchange considering the content requirements for the five (5) ISO International Standards: - EN ISO IS 11615 Health Informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information; - EN ISO IS 11616 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information; - EN ISO IS 11238 Health Informatics - Identification of medicinal products - Data elements and structures Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances; - EN ISO IS 11239 Health Informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging; and - EN ISO IS 11240 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement In addition, this project scope will encompass all European Union (EU)/European Medicines Agency (EMA) requirements for EU implementation of the five IDMP standards listed above utilizing HL7 SPL to support their legislative requirements for product registration and pharmacovigilance. Review the final comments with the disposition status 'Considered for future use' published under 'Reconciliation JIC Health Informatics - Identification of Medicinal Products - Data elements and structures for unique identification and exchange of regulated medicinal product information, Release 1 (3rd Normative Ballot) - JIC_IDMP_MPID11615_R1_N3_2014JAN' document. Review and update IDMP and CPM/SPL element mappings and gap analysis. Review CPM and extend SPL to ensure all the EU requirements as stated in ISO Technical Specifications and Standards are met. Review CPM from business process point of view, e.g. 'update', 'request IDs' or 'queries' etc. and add/harmonise where necessary. Take into account whether or not datatypes should be constrained to ensure that the standard will not require changing shortly afterwards because of obsolete datatypes. In the resultant model and documents, explain what previous work was leveraged (or not) and why. The idea being that if some existing work isn't used, we may be able to retire material if the reasoning is understood or use and update whatever is useful and necessary to accomplish the task and avoid duplication. |
Project Facilitator | Vada Perkins, Paolo Alcini |
Status | Archived |
SD Approval Date | Awaiting Approval |
TSC Approval Date | Mar 3, 2014 |
Type | ISO JIC Ballot Project |
Objectives / Deliverables | Acceptance of IDMP IG Ballot Project by HL7 RCRIM - Target: 2015 Jan RCRIM WGM Submit HL7 Project Scope Statement for IDMP Project - Target: 2015 FEB 1 Submit for HL7 Notice of Intent to Ballot - Target: 2015 FEB 22 Initial IDMP Ballot Content for SPL R7 and CPM - Target: 2015 MAR 8 Normative SPL Release 7 Ballot - Target: 2015 May Ballot SPL Release 7 Ballot Reconciliation - Target: 2015 May WGM Publish Normative SPL Release 7 - Target: 2015 SEP WGM Project End Date (all objectives have been met) - Target: 2015 SEP WGM |
Next Milestone Date | 2017 May WGM |
Project End Date | 2017 May WGM |
Project Intent | Revise Current Standard, Implementation Guide, Externally developed IG is to be Adopted |
Project Need | This project helps address ISO and HL7 ballot comments related to consistent IDMP standards implementation and use internationally. The ISO IDMP standards are based upon HL7's Common Product Model as the overarching information model and therefore HL7 input is needed to help ensure consistency with any associated CMETs and vocabulary requirements. Additionally, the Structured Product Labeling (SPL) Release 7 standard is also referenced as the data exchange format for IDMP information exchange. Due to the interdependencies with HL7 modeling and messaging constructs used for IDMP standards, ISO TC 215 Workgroup 6 believes it is important that the ISO Technical Specifications be reviewed in HL7. |
Implementers | |
Security Risks | Don't Know |
External Drivers | ISO TC 215 WG 6 timelines for ISO balloting of ISO IDMP DTS documents and ballot reconciliation. Regulators: FDA and EMA/EU (through bilateral agreement) |
Common Names / Keywords/ Aliases | ISO IDMP, IDMP, EU Requirements for HL7 CPM/SPL , SPL R7 |
Lineage | HL7 SPL R6 |
Dependancies | The following projects have a reference to IDMP work: Project ID 858: Common Product Model Project ID 501: IDMP Terminologies Project (JIC Project) Project ID 325: SPL Release 7/Medicinal Product Information Project ID XXX: Substances CMET |
Project Document Repository | HL7 Publishing Document Repository |
Backwards Compatibility | Yes |
External Vocabularies | |
Products | V3 Documents-Administrative (e.g. SPL); V3 Foundation-RIM |
Joint Copyright? | Yes |
External Pjt Collaborators | SDOs: ISO TC 215 WG 6 and GS1 (SDO Joint Agreement) Regulators: FDA and EMA (through bi-lateral agreement) European Directorate for the Quality of Medicines and Healthcare (EDQM) |
Realm | Universal |
HL7 Affiliate | |
Stakeholders | Regulatory Agency, Standards Development Organizations (SDOs), Other (specify in Misc. Notes below) |
Vendors | Pharmaceutical |
Providers | N/A |
Ballot Cycle Info | 2015 June OOC Ballot: Did not meet basic vote requirements HL7 Version 3 Standard: Common Product Model (CPM) CMETs, Release 3 (PI ID: 1147) HL7 Version 3 Standard: Structured Product Labeling, Release 7 (PI ID:1147) 2015 May Ballot Cycle Info: NORMATIVE Ballot results: WITHDRAWN Document Name: HL7 Version 3 Standard: Structured Product Labeling (SPL) Release 7 |
Misc Notes | Dec 2017: TSC approved Normative publication request for HL7 Version 3 Standard: Common Product Model (CPM) CMETs, Release 4 at TSC Tracker 14227 June 2016: Received ANSI approval for HL7 Version 3 Standard: Common Product Model CMETs, Release 3. PMO archiving project. May 2016: Received ANSI approval for HL7 Version 3 Standard: Clinical Statement CMETs, Release 1 May 2016: Received ANSI approval. Status set to 'Ready for Normative Edition'; no further work from the project team necessary. Mar 2016: TSC approved normative publication for Common Product Model CMETs, R3 Jan 2016: TSC approved normative publication for HL7 Version 3 Standard: Structured Product Labeling (SPL), Release 7 Nov 2015: TSC approved a recirculation ballot of HL7 Version 3 Standard: Common Product Model (CPM) CMETs, Release 3 at TSC Tracker 8955 |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Oct 13, 2014 |
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