ISO IDMP has spent a decade being described as a project for the IT department. That description stops working in December 2026, when the European Medicines Agency expects structured manufacturer data for every non-centrally authorised product in your portfolio to be sitting in the Product Management Service. The work is regulatory, the data is yours, and the queue at the end is real.
What the PMS actually replaces
The Product Management Service (PMS) is the product domain of EMA’s SPOR programme, alongside the referentials, organisations and substances services. Once fully implemented, PMS will fulfil the legal requirements of Article 57 of Regulation (EC) No 726/2004 — the obligation that the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) has carried for well over a decade.
EMA completed the preparatory phase in March 2024, launching the referentials and organisation management services and migrating data from existing systems such as SIAMED and XEVMPD into PMS. Until PMS is fully operational, the two systems run in parallel. EMA is explicit that transition periods with multiple systems in use are unavoidable, so the honest planning assumption is that you maintain both for some time yet.
The deadlines now on the calendar
EMA publishes submission deadlines by activity. Three matter to marketing authorisation holders:
- June 2026 (now passed) — enrichment of structured manufacturer data and pack size for non-centrally authorised products featuring on the Union list of critical medicines, via the PMS product user interface (PUI) and API.
- December 2026 — enrichment of structured manufacturer data for all other non-CAPs in the company’s portfolio, via the PUI and API.
- June 2027 — enrichment of pack sizes for all other non-CAPs using XEVMPD, and structured pack sizes using the PMS PUI and API.
Two of these were extended by EMA in September 2025 to allow the orderly completion of enrichment activities. That extension is best read as breathing room already spent rather than as a precedent for the next one.
Why this is a data problem, not a submissions problem
Nothing here is a dossier you write. It is your own master data, exposed. Enrichment means that every manufacturing, testing and release site attached to a product must resolve to a registered organisation entry, and that pack sizes must be expressed as structured values rather than free text. Three things reliably surface once teams start:
- Sites that exist in the dossier under one name, in the ERP under another, and in the organisation register under a third — or not at all.
- Pack descriptions that were never structured because no system previously demanded it.
- Divergence between national registers, the approved product information and the company’s internal source of truth.
Each of these is resolvable. None is resolvable quickly in the last fortnight before a deadline, because registering or correcting an organisation record depends on a third party’s turnaround, not on yours.
The public API changes who can see the result
EMA released the public PMS API beta in June 2026, with a final version expected in early 2027 after a period of stakeholder testing. This is the first time PMS medicine data has been made available externally through a programmatic interface. Data quality that used to be a private matter between a company and a database becomes visible, comparable and reusable — by regulators, by national authorities and, increasingly, by anyone building on the public dataset.
How PQRA helps
We treat IDMP readiness as a regulatory data exercise rather than a software purchase. That means reconciling product, site and pack data across the dossier, the product information and national records; registering and correcting organisation entries; preparing enrichment through the PUI and API; and setting the governance that keeps the data accurate through subsequent variations. For companies operating in Greece and across the EU, we align PMS work with existing XEVMPD obligations so nothing is maintained twice without reason.
If December 2026 is closer than your data is ready, now is the point at which the gap is still cheap to close. Talk to PQRA about your IDMP and PMS readiness.
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