Identification of Medicinal Products (IDMP) Compliance Solutions

Through accurate data mapping and PMS ID linking, we can help you significantly enhance data consistency and regulatory integrity. Traceability also improves, while compliance risks are reduced. Our consultants help with:

• Consolidating RIMS and PMS datasets into a structured environment for standardized processing and traceability.

• Linking PMS IDs with their corresponding RIMS records to ensure full traceability.

• Systematically detecting and flagging missing, duplicate, and inconsistent identifiers to improve data reliability.

• Maintaining data accuracy through user reviews and corrective actions to resolve discrepancies.

Good data verification and governance involve establishing and maintaining a controlled dataset that supports repeatable IDMP compliance in pharma. Manual verification and rework must also be minimized to improve data quality, optimize traceability, and facilitate sustainable maintenance. We help with:

• Identifying equivalent fields across different data sources to ensure standardization and consistency.

• Uncovering alignment gaps, discrepancies, and inconsistencies in your dataset using automation.

• Correcting data gaps, discrepancies, and inconsistencies through structured cleanup.

• Establishing rules, ownership, and oversight to ensure ongoing data accuracy, integrity, completeness, and compliance.

Repeatable submission and maintenance reduce manual effort and ensure ongoing data integrity and compliance. Our expertise includes:

• Developing and implementing a structured approach to access data from multiple sources.

• Identifying and resolving data errors and inconsistencies.

• Submitting data through the PMS API.

• Managing change requests and submitting PMS updates using the PUI on EMA’s PLM Portal.

IDMP and SPOR requirements will continue evolving beyond June 2027. An optimized compliance approach involves establishing a framework that supports changing regulatory requirements. Our consultants help with:

• Identifying potential issues early through readiness and gap assessments against emerging IDMP and SPOR requirements.

• Extending mapping and governance processes across the EMA's wider SPOR reference data services, covering organization, substance, and referential data alongside PMS product data.

• Designing enrichment and submission processes that are compatible with new requirements, such as eCTD 4.0.

• Monitoring and responding to changes in the broader regulatory landscape, including the shift toward IDMP that is already underway at other authorities such as the FDA.

IDMP (Identification of Medicinal Products) is a suite of ISO standards (ISO 11238, 11239, 11240, 11615, 11616) that define how medicinal product data is structured and identified. Medicinal product data includes substances, dosage forms, units, and packaging. The goal is to ensure data can be exchanged consistently between companies and regulators.

PMS is the European Medicines Agency's system for managing structured, IDMP-compliant medicinal product data. It is replacing the older XEVMPD system (although both will co-exist for the time-being during transitional maintenance) and uses HL7's FHIR (Fast Healthcare Interoperability Resources) as its data submission format instead of XEVMPD's XEVPRM format. It is being rolled out to Marketing Authorization Holders (MAHs) in stages.

At the time of writing, there are two active deadlines for non-centrally authorized products:

• December 2026 for structured manufacturer's data

• June 2027 for pack-size enrichment

Products on the EU's Union List of Critical Medicines (ULCM) had an earlier deadline of June 2026. Requirements continue to evolve, so MAHs should treat compliance as an ongoing process rather than a single date.

Not in the same way. Centrally authorized products (CAPs) have already been migrated into the EMA's Product Management Service, with their data brought across from SIAMED and XEVMPD into ISO IDMP-compatible format.

There are no submission deadlines for CAPs the way there are for non-CAPs. Instead, the ongoing requirement is keeping the data accurate through the PMS Product User Interface and API. The staged deadlines (June 2026, December 2026, and June 2027) apply specifically to non-centrally authorized products, i.e., products authorized through mutual recognition, decentralized, or national procedures.

A RIMS (Regulatory Information Management System) platform is a company's internal system for managing its own regulatory data across products and markets. The EMA PMS is the regulator's external system for receiving and holding IDMP-compliant product data. While different, keeping the two aligned and consistent is a key objective for life sciences companies as well as one of the core challenges of IDMP compliance. Aligned and consistent involve ensuring the data in a company's RIMS matches what is submitted to PMS.

SPOR stands for Substance, Product, Organization, and Referentials. They are the four EMA master-data services that together provide the reference data that IDMP submissions rely on. PMS is where product data is managed. The other SPOR services (OMS, SMS, RMS) manage organization, substance, and referential data respectively.

Mandatory ISO IDMP compliance currently applies in the EU and is enforced through the EMA's PMS rollout. Other regulators, including the FDA, are moving in the same direction. Work in many jurisdictions is underway on IDMP-aligned data standards. Therefore, global convergence toward IDMP is expected even in locations where it is not yet a legal requirement.

NNIT combines regulatory affairs advisory with automated data tooling to help Marketing Authorization Holders map, verify, and submit IDMP-compliant data to the EMA PMS. This includes linking PMS IDs to RIMS records, resolving data inconsistencies across systems, establishing good data governance, and managing EMA PMS submissions through the PMS API and Product User Interface on the PLM Portal (Product Lifecycle Management Portal).

NNIT helps establish clear data ownership through defined stewardship roles, a RACI matrix, and documented change-control routines. This ensures IDMP compliance becomes a managed and repeatable process and involves ongoing verification of data as it moves between RIMS, XEVMPD, and PMS.