Danish DHPC submission checker
The Danish market issues roughly ten DHPCs a year, so no company does one often enough to remember the Danish Medicines Agency's specifics. Denmark is unusual: the MAH supplies the Danish draft, the Agency quality-assures it — and can send it back "if the quality of the translation is poor" — and the Agency, not the MAH, distributes it (e-Boks, Digital Post, regional hospital mailboxes, pro.medicin.dk for six months). This checklist follows the Agency's own published process. Runs in your browser; nothing is sent to ClinicOps.
No summary built yet.
Nordic notes — same letter, different mechanics
Verified on the respective agency pages on 2026-09-24 unless marked otherwise. Use as orientation; each agency's live guidance governs.
| Country | Who distributes | What the MAH submits | Distinctive rules |
|---|---|---|---|
| Denmark (Lægemiddelstyrelsen) | The Agency (e-Boks/Digital Post to HCPs by authorisation register and specialty; regional hospital mailboxes; website; pro.medicin.dk for 6 months). MAH does not post letters. | Draft Danish + final English + Danish-adapted recipient proposal + CVR numbers + MAH contact, by email within the agreed timeframe. | No logo at top; PI updates linked, not attached; Agency may return poor translations; parallel importers generally not required to participate. |
| Norway (DMP / NOMA) | Split: NOMA to GPs via EHR and publishes; MAH still emails pharmacies and posts to other groups. | English + Norwegian + recipient proposal to the agency's ADR mailbox. | NOMA safety-information logo required; mandatory Norwegian ADR-reporting text block. (Guidance updated Sep 2026.) |
| Sweden (Läkemedelsverket) | MAH postal distribution remains the requirement; a digital-mailbox pilot ran 2024–2025. | Swedish DHPC agreed with the agency; publication via agency channels / Fass. | Roughly 20–30 DHPCs a year — the highest Nordic volume. |
| Finland (Fimea) | Fimea publishes MAH DHPCs on its site; MAH distributes. | Finnish DHPC (Swedish-language rule not verified on the review date). | Fimea recommends nominating a local PV contact person (not mandatory). |
Tool assessment (documented-tool record)
Purpose, requirements, test evidence, limitations, change log
Purpose. Structure the preparation of a Danish DHPC against the Danish Medicines Agency's documented process and GVP Module XV, and produce a readiness summary listing open items for the QPPV. A structuring aid; never the system of record.
Requirements. R1 Every checklist item traces to the Agency's DHPC page or GVP Module XV. R2 The summary lists every unticked item as open, grouped by section, and every ticked item as confirmed. R3 The summary carries product, agreed date and the notes field verbatim. R4 All processing is local; no network calls after page load. R5 Version and change log shown.
Test evidence (v1.0, 2026-09-24). T1 Nothing ticked → summary lists all items open; counts equal the item total. Pass. T2 All ticked → zero open, "ready for internal QPPV sign-off" line shown. Pass. T3 Notes text present → reproduced verbatim in the summary. Pass.
Known limitations. Does not translate, does not check readability automatically, does not know the agreed EU timeline. Nordic notes are orientation only. The Agency's page may change after the review date.
Change log. v1.0 (2026-09-24): first release; 26 items in six sections; Nordic notes for NO/SE/FI.
When the open items are Danish-language work
A draft that reads like a translation gets returned. If the open items are the Danish draft itself — plain Danish, active voice, short sentences, the Agency's translation guideline — or a Danish recipient proposal nobody in the hub can build, that is the bounded work ClinicOps takes on, reviewed by a medically trained native Danish speaker under your QPPV. See the Danish pharmacovigilance capability →