The EMAs phased implementation of IDMP is well underway, with key milestones approaching in Q3 2025. Data enrichment is already available for all products through the Product User Interface, XEVMPD. Soon the API will be live to connect your RIM systems to carry out automatic data enrichment. This will allow MAHs to add data on pack sizes and manufacturers, not covered by XEVMPD. The current EMA Roadmap for Product Management Service (PMS) implementation provides a timeline for actions to be carried out by the MAH.
Product Management Service (PMS) Data Flow:
Data for PMS has been initially migrated from existing sources of XEVMPD, SIAMED II, OMS, SMS and RMS. This data is now publicly visible and editable by MAHs.
Next Steps:
There are 2 key actions required of MA Holders:
- QC check of data already migrated to PMS
Some known issues with data migration to look out for are:
- Incorrect section numbering
- Iceland, Liechtenstein and Norway merged into a single PMS product entry
- Incorrect LOC IDs for Regulator Organisations
- Incorrect or missing ingredients
- Incorrect packaging or storage information
- Data enrichment in XEVMPD and PMS (via PUI or API)
- MAHs should add or correct any missing or incorrect data in XEVMPD, this will filter down to PMS
- MAHs can also add additional data not available in PMS such as structured pack details and manufactures through the PMS User Interface or API when it is available. All data added must be compliant with SPOR terms
For data enrichment, any non-CAP products on the Union List of Critical Medicines (ULCM) should be prioritised over non-critical medicines.
To be able to carry out data enrichment, an MAH much have a system for tracking registered information that is compliant with IDMP and uses standard SPOR terms.
- If your company is using a validated eRIMS system, is it IDMP compliant? or may configuration changes be needed in order to gather this data for migration to PMS?
- If you are not using a validated eRIMS system, is your current manual tracking system capable or tracking data in compliance with IDMP or will you need to implement a validated system?
- Does your company have processes for maintaining PMS compliance?
- With your current resource, how do you plan to maintain PMS? Manually via the PUI or linking a validated eRIM using an API? This will depend on the scale of your product portfolio and level of resource available
Acorn Regulatory can support MAHs in understanding the requirements of IDMP and guide them towards compliance. This support can be tailored towards your existing systems or involve implementing new ways or working such as introduction of a validated eRIMS. Contact us at enquiries@acornregulatory.com for more information.
Glossary of terms:
IDMP – Identification of Medicinal Products
SPOR – Substance, Product, Organisation, and Referential data management services. The program to provide ISO standardized terms for the purposes of IDMP.
SMS – Substance Management Service
PMS – Product Management Service
OMS – Organisation Management Service
RMS – Referential Management Service
XEVMPD – Extended EudraVigilance Medicinal Product Dictionary
API – Application programming interface
PUI – Product User Interface
ULCM – Union List of Critical Medicines
CAP – Centrally Authorised Product
NAP – Nationally Authorised Product
RIM – Regulatory Information Management
EMA – European Medicines Agency
MAH – Market Authorisation Holder
