IDMP compliance data built from the documents you already approved — every field traced to its page
Every product's IDMP and ePI data ready for EMA, each field traced to its page.
See one case, screen by screen ↓IDMP is the ISO model EMA's Product Management Service uses for every medicine: substance, product, packaging and manufacturer. Marketing authorisation holders must add structured manufacturer data for every nationally authorised product by 31 December 2026 and structured pack sizes by June 2027; products on the critical medicines list were due in June 2026.
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EMA wants structured manufacturer data in its Product Management Service for every nationally authorised product by 31 December 2026, structured pack sizes by June 2027, and is rolling out electronic product information. None of the facts are new. The strength is in SmPC section 2 and Module 3.2.P.1, the container in section 6.5 and 3.2.P.7, the sites in 3.2.P.3.1 and the leaflet, the legal status on the carton — each document owned by a different team. Today a regulatory data steward copies each value into a spreadsheet, then into PMS, and looks up every one in EMA's RMS, OMS and SMS lists by hand.
Free text such as “Aluminium/aluminium blisters” matches no EMA term, so the steward guesses or raises a request. And the approved documents disagree: a pack size in the SmPC that Module 3 never registered, a site address written two ways, a shelf life changed by a variation in one document only. Then the leaflet has to be structured a second time for ePI, while the deadline does not move.
Estimated split for one product record across regulatory, CMC, supply and labeling, by hand and with the solution.
Five specialist agents read, match, check and structure every product; a regulatory data steward decides and signs.
Veltara Therapeutics holds 412 nationally authorised products in 21 EEA countries. The 31 on the critical medicines list were accepted by EMA in June; 79 days remain before the December deadline for the rest. Here is one of them, screen by screen, in the working solution.
VLT-118, Narvexa 50 mg film-coated tablets (selvoranib), decentralised procedure DK/H/3318/001/DC, authorised in 9 countries. Its SmPC and leaflet v4 were approved on 14 March, but the record shows 0 of 64 fields. Ines presses “Read approved documents”, and the fields begin to fill with a line from each one to the sentence it came from.
“4 approved documents are waiting: SmPC v4 and leaflet v4 (14 Mar 2026), the 28-tablet carton, Module 3 sequence 0007.”
The field extractor reads the SmPC, the leaflet, the carton label and the Module 3 extracts — 23 pages — and fills the Substance, Pharmaceutical product, Packaged product and Manufacturer sections. Every value carries its source: SmPC §2, 3.2.P.1, Leaflet §6, Carton. SmPC sections 4.3 to 5.3 are clinical text and are not used for the product record. Three fields are left for Ines.
Readiness scorer: “61 of 64 · ready after 3 decisions by the steward.”
SmPC section 3 says “Film-coated tablet.” and describes it as round and biconvex. The authorised dose form snaps to the RMS term Film-coated tablet, RMS 100000073665, at 99%. Excipients snap to SMS substances, the holder to its OMS organisation, the route and the legal status to RMS terms — 38 values in all.
The matcher never snaps below 0.95 and never invents a term.
The immediate container material glows amber with the three nearest EMA terms. Blister · Aluminium / Oriented polyamide / PVC (cold-form) scores 91%, because Module 3.2.P.7 describes cold-formed OPA 25 µm / Al 45 µm / PVC 60 µm. Blister · Aluminium / PVC misses the polyamide layer (62%); Strip · Aluminium scores 40%, since 3.2.P.7 says blister. She picks the cold-form term — a click, not a ticket.
If none fits: “None fits — request a new term.”
The leaflet names the batch release site as “Archimedesweg 41, 2333 CM Leiden”; EMA's organisation list holds Veltara Pharma B.V. at Archimedesweg 41-43, the address Module 3.2.P.3.1 uses. The matcher offers that location at 89%, against the company's offices and the holder's own address. She snaps the site to its OMS location.
“8 other products name the Leiden site the same way.”
SmPC §6.5 reads “Packs of 28, 56 and 98 film-coated tablets.” Module 3.2.P.7 registers 28 tablets in 2 blisters and 56 in 4, and the leaflet lists 28 or 56 only. Ines excludes the 98-tablet pack from the record, and follow-up FU-0218 goes to Sofie Vandermeer to align SmPC §6.5 at the next variation.
“The agent never decides which document is right.”
All 64 fields are filled and every decision is made. Ines signs with her password and the meaning of the signature: approved for submission to EMA's Product Management Service. The record becomes version 5, and the 9 Narvexa products join batch PMS-0427, to be sent by Martin Aldred.
“Signed · 9 Narvexa products added to batch PMS-0427.”
The ePI structurer reads leaflet v4 — 6 pages, 4,812 words, in English, Dansk and Deutsch — matches 6 of 6 QRD sections and 31 subsections, keeps its 2 images and links the ePI to VLT-118's packs of 28 and 56. The check against the approved text: 0 words changed. A phone preview shows what a patient will see, and the ePI goes to Sofie for approval.
The ePI structurer never rewords approved text; the labeling manager approves every ePI.
Narvexa moves the board to 318 ready, 71 needing review and 23 with gaps; 26,381 of 27,480 fields (96%) are filled from approved documents. At 14 products a week, the last of the 381 is ready by 29 November. Each product says why it is not ready — Telvoqa's shelf life is 2 years in the SmPC and 36 months in Module 3.
Batch PMS-0427 now holds 46 signed products, waiting to be sent. The last batch, PMS-0419, had 44 accepted and 2 returned: Telvoqa's pack size was given in ml where EMA expects the unit of presentation “Bottle” — one fix covers Germany and Austria. The record history shows every version, from the approved SmPC to Ines's signature.
“Acceptance this quarter: 188 of 190 products first time.”
The same product record, seen by the four people who answer for it — what their month looked like, and what it looks like now.
Five specialist agents read, match, check and structure every product; a regulatory data steward decides and signs.
Reads every approved SmPC, leaflet, label and Module 3 section and fills each IDMP field — substance, product, packaging, manufacturer — with the document, version, section and sentence it came from, taking the value from the source the priority settings name first.
Snaps each value to its EMA reference term — RMS for forms, routes, containers and materials; OMS for organisations and sites; SMS for substances — and ranks the nearest three, with the evidence, when it cannot.
Compares the SmPC, leaflet, label and Module 3 for every product and shows both passages wherever they disagree.
Turns the approved leaflet and SmPC into ePI to the EU ePI Common Standard: sections under their QRD headings, images and links to the product record.
Scores every product against EMA's deadline lanes, says why a product is not ready and prepares the submission batches.
Decides and signs. The agents propose; a named person decides.
Ask in plain words — every answer points to the page it came from.
Why is Narvexa 50 mg not ready yet?
Three things are left, all for you: “Aluminium/aluminium blisters” matches no EMA term — Module 3 says cold-formed OPA/Al/PVC; the leaflet writes the Leiden site as “Archimedesweg 41”, EMA's list has “41-43”; and SmPC §6.5 lists a 98-tablet pack that Module 3 never registered.
Which products could miss the December deadline?
At today's pace — 14 products a week — the last of the 381 is ready by 29 Nov. The risk is the 23 products with gaps: Telvoqa (14 countries) has a shelf life that differs between SmPC and Module 3 and an amber-glass bottle with no single term; Pruvalan (11) lists a second batch release site only in Module 3.
Apply the cold-form blister term to every product with the same wording
The wording “Aluminium/aluminium blister” is used in 29 products. For Narvexa, Module 3.2.P.7 confirms cold-formed OPA/Al/PVC; I checked each of the others against its own Module 3 before proposing it. The list is open for your approval — nothing changes until you approve.
Show Narvexa as electronic product information
Here is the approved leaflet v4 structured to the EU ePI standard: six QRD sections, two images and links to the product record — and not one word of approved text changed.
13 screens from the working solution, on its sample data. Pick one to see it large.
How the agents read, match and score — and who decides — are settings. Every change is versioned and on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Source priority · ingredients and strengths | Module 3.2.P.1 → SmPC §2 | Change proposed by the steward, approved by the operations lead |
| Source priority · packaging and pack sizes | Module 3.2.P.7 → SmPC §6.5 → carton | Change proposed by the steward, approved by the operations lead |
| Source priority · manufacturers and sites | Module 3.2.P.3.1, 3.2.S.2.1 → leaflet §6 | Change proposed by the steward, approved by the operations lead |
| Snap threshold | 0.95 | 0.90 · 0.95 · 0.98 |
| Reference lists | RMS, OMS and SMS refreshed from EMA at 02:00 daily | Nightly, from EMA |
| Apply a term to the same wording | With approval | With approval · Off |
| Who decides | Steward signs the record · labeling manager the ePI · operations lead the batch | e-signature for each; organisation and site data by approval of the master data manager |
| Manufacturer data deadline | 31 Dec 2026 | Reminders 60 / 30 / 14 days before |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample portfolio · “target” = the design goal, measured in the live solution · “estimated” = our estimate (3 weeks per record by hand, and the split of its days) · Deadlines: EMA, Substance and product data management services (PMS enrichment: critical medicines June 2026, manufacturer data Dec 2026, pack sizes June 2027) · EMA ePI roadmap (draft, Mar 2026) · ISO IDMP 11615/11616/11238. People, companies, products and sites named on this page are fictional — characters and sample data in the working solution.
IDMP is the ISO model EMA's Product Management Service uses for every medicine: substance, product, packaging and manufacturer. Marketing authorisation holders must add structured manufacturer data for every nationally authorised product by 31 December 2026 and structured pack sizes by June 2027; products on the critical medicines list were due in June 2026.
The field extractor reads the approved SmPC, leaflet, label and Module 3 sections and fills each IDMP field, taking the value from the source your priority settings name first — for example Module 3.2.P.1 before SmPC section 2 for ingredients and strengths. Every field records its document, version, section and sentence; a field without a sentence stays empty.
The SPOR term matcher snaps each value to its RMS, OMS or SMS term at 0.95 or more. Below that, the value glows amber with the three nearest terms and the evidence for each, and the steward picks one — or requests a new term from EMA. One decision can cover every product with the same wording, once the steward approves the list.
The cross-document checker shows both passages side by side — a pack size registered in one document only, a site address written two ways, a shelf life changed by a variation. It never chooses; the steward decides, and each decision opens a follow-up to the document owner so the next version matches.
Yes. The ePI structurer turns the approved leaflet into ePI to the EU ePI Common Standard: QRD sections, images and links to the IDMP record's packs, exported as a FHIR bundle. It compares the result with the approved text and never rewords it; the labeling manager approves every ePI.
No. The readiness scorer prepares batches of signed records; the regulatory operations lead sends each batch to PMS. Each product EMA returns appears with EMA's reason.
Yes. The agents fill, match, compare and score; the regulatory data steward picks uncertain terms, settles conflicts and e-signs every record, the labeling manager approves every ePI, and the operations lead sends every batch. Every change is a new version, and nothing is overwritten.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your source priorities, approvers and a sample of approved SmPCs, leaflets, labels and Module 3 — and it goes live once every quality gate has passed. We will walk you through it on your own products first.
Every agency change reaches the right team within hours, with what changed marked.
1-min demoCTD Module 2 AuthoringModule 2 summaries drafted in weeks, every statement cited to its source.
1-min demoHealth Authority Query ResponseCited first drafts within hours, consistent with every past answer to every agency.
1-min demoWe'll run IDMP & ePI Product Data Readiness on a sample of your own approved SmPCs, leaflets and Module 3.