Danish local-literature source register
GVP Module VI (VI.B.1.1.2) expects marketing-authorisation holders to have "procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation". Denmark publishes no authority list, so every PV team re-derives one. This is a versioned, source-verified starting point — with the justification memo and the weekly screening log your PSMF and your auditor will ask for. Runs in your browser; nothing is sent to ClinicOps.
Register v1.0 — 2026-09-24
Verification legend: V = verified at the cited source on the review date (ISSN Portal, NLM Catalog / PubMed, publisher page, Lægemiddelstyrelsen). U = not verified. Tiers: core Danish-language, drug-safety content, not captured by an English database search · specialist product-type dependent · awareness news/signal awareness, not an ICSR venue · regulator authority output · historical ceased.
Generate the justification memo and the screening log
Select the sources that fit your portfolio, describe the products and the method, and generate two records: a journal-list justification memo (what you screen, what you deliberately do not, and why) and a weekly screening-log template with the negative-result line GVP VI Appendix 2 record-keeping expects.
No memo generated yet.
Tool assessment (documented-tool record)
Purpose, requirements, test evidence, limitations, change log
Purpose. Provide a source-verified register of Danish periodicals and regulator outputs relevant to local-literature monitoring, and generate a journal-list justification memo and a screening-log template from user selections. The tool is a structuring aid; it is never the system of record. Outputs are filed in the MAH's own controlled system.
Requirements. R1 Every register row states owner, language, ISSN, cadence, audience, indexing and a verification status with date. R2 The memo lists every selected source with its rationale and every unselected source as a documented exclusion. R3 The memo quotes the GVP VI.B.1.1.2 wording verbatim and names the MAH as decision owner. R4 The log template contains a negative-result ("nil found") field and a first-awareness date field for every screened issue. R5 All processing is local to the browser; no network calls after page load. R6 The register carries a version and a review date; changes are recorded in the change log.
Test evidence (v1.0, 2026-09-24). T1 Default selection, two products, MLM "none" → memo lists the 3 pre-selected sources (Ugeskrift for Læger, Månedsskrift for almen praksis, Lægemiddelstyrelsen outputs) as screened and the remaining 11 as documented exclusions; log CSV has one header row and one example row per selected source. Pass. T2 Dental box ticked → Tandlægebladet moves to selected with the dental rationale. Pass. T3 All sources unticked → tool refuses to generate and reports that at least one source is required. Pass.
Known limitations. The register does not screen content and cannot tell you whether a specific article is reportable. Indexing status reflects the review date and can change. ISSNs marked U are unconfirmed. The Nordic sister sources (SE/NO/FI) are not included in v1.0.
Change log. v1.0 (2026-09-24): first release; 14 Danish sources plus Lægemiddelstyrelsen outputs; "Nyt om bivirkninger" recorded as discontinued (renamed 4 Sep 2017).
When the free structure meets real screening work
If the memo exposes sources nobody on your team can read, or a Danish issue queue that never gets closed, that is the bounded work ClinicOps takes on: Danish-language screening against a justified list, with first-awareness logging, handover on your clock and periodic reconciliation. See the Danish pharmacovigilance capability →