EMA updated several Product Management Service/ISO IDMP implementation documents on August 12, including Chapter 3 covering the electronic submission and maintenance of medicinal-product information.
For marketing authorization holders, this is less a “new regulation” story than a regulatory-data-governance story.
The updated Chapter 3 is Version 3.7. EMA says this version makes Manufacturer Authorisation Reference Number, Effective Date and Regulator fields optional for conformance and clarifies which Manufacturer Business Operations are not tracked in SIAMED for centrally authorized products and therefore do not need to be provided in PMS.
Why This Matters
Modern regulatory operations increasingly depend on structured data moving between multiple systems.
EMA’s PMS model involves connections among systems and processes such as:
- SIAMED;
- XEVMPD;
- Product Management Service;
- eAF;
- PMS API;
- Product UI.
EMA states that the guidance covers initial submissions as well as maintenance activities including variations, renewals, transfers, invalidations and data corrections.
The practical risk is easy to see: the medicinal product itself may be unchanged while its regulatory data becomes inconsistent across systems.
Regulatory Foundation
EMA notes that ISO IDMP use is required under Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012, while Article 57(2) of Regulation (EC) No 726/2004 establishes obligations around electronic submission of medicinal-product information.
The key challenge is not only understanding the obligation but knowing which system is authoritative for which type of update.
What the Current Operating Model Requires
For centrally authorized products, EMA describes product information flowing through SIAMED and XEVMPD into PMS.
For non-centrally authorized products, much of the source information originates through XEVMPD.
For variations, MAHs remain responsible for relevant XEVMPD updates. EMA states that where applicable, changes to marketing-authorization terms must be notified through the electronic format within the established timeframe, and downstream PMS data is then updated.
PMS also contains an enrichment process for information that was absent from migrated source data.
For non-centrally authorized products, certain enriched data can be maintained through the Product UI or PMS API.
What Version 3.7 Changes
Version 3.7 specifically clarifies conformance expectations for three manufacturer-related fields:
- Manufacturer Authorisation Reference Number;
- Effective Date;
- Regulator.
These are now designated optional for conformance in the circumstances explained by EMA.
The update also clarifies Manufacturer Business Operations not tracked in SIAMED for centrally authorized products and therefore not required in PMS.
This sounds small until a company has automated validation rules that still treat those fields as mandatory.
Then an implementation clarification becomes a system-validation and data-quality issue.
What Should MAHs Review?
Regulatory operations teams should consider checking:
- Internal IDMP/PMS instructions against Version 3.7.
- Automated validation rules.
- Data-quality dashboards.
- Manufacturer-master-data governance.
- CAP vs non-CAP workflows.
- XEVMPD/PMS responsibilities.
- Procedures for enrichment.
- Procedures for corrections.
- Change-control documentation for regulatory systems.
EMA warns that incorrect execution of some transfer processes can create new medicinal-product records and interfere with correct lifecycle tracking.
That is exactly why this should not be treated as a “regulatory submission form update.”
It is master-data governance.
A small error can propagate downstream.
Example:
Suppose a non-CAP product undergoes an approved change affecting manufacturer data.
The regulatory procedure closes correctly, but the associated enriched PMS information is not updated because the organization assumes all product information will flow automatically from XEVMPD.
EMA’s current guidance makes clear that for certain non-CAP enriched data, the MAH must maintain that information directly in PMS.
The approval itself may be fine.
The structured regulatory dataset is not.
That distinction is increasingly important as regulators rely more heavily on reusable structured product information.
Frequently Asked Questions
What is EMA PMS?
Product Management Service is part of EMA’s structured medicinal-product information ecosystem supporting ISO IDMP implementation.
What changed in Version 3.7?
EMA clarifies conformance treatment for Manufacturer Authorisation Reference Number, Effective Date and Regulator and provides additional manufacturer-business-operation clarification.
Does PMS replace XEVMPD immediately?
No. EMA’s current model still uses XEVMPD for several lifecycle-data activities.
Are CAP and non-CAP workflows the same?
No. EMA describes different source systems and maintenance paths for centrally and non-centrally authorized products.
What should regulatory operations teams do first?
Compare internal work instructions and validation rules with the Version 3.7 change summary.