SDEA / PV agreement clause checker
From 12 February 2026, Commission Implementing Regulation (EU) 2025/1466 requires every pharmacovigilance subcontract to contain a defined clause set (Regulation (EU) No 520/2012 as amended, Article 6(3)–(4)) and makes risk-based audit of third parties mandatory (Article 13) — "even if the obligation pursuant to Article 6(3) has not yet been included in the subcontract". Paste an agreement, or answer the checklist, and get a gap report where every rule carries its citation. Runs in your browser; nothing is sent to ClinicOps.
1. Agreement details
3. Gap report
No report built yet.
4. Reconciliation log template
Article 6(3)(b) requires the safety-data exchange obligation and method to be written down; inspectors then expect evidence that the exchange actually happened. A periodic reconciliation — cases sent versus cases received, discrepancies and their closure — is that evidence. Fill a period and download the log.
| Partner | Period | Cases sent | Cases received | Discrepancies | Resolution / closure date | Owner |
|---|
Tool assessment (documented-tool record)
Purpose, requirements, test evidence, limitations, change log
Purpose. Screen a pharmacovigilance agreement against the clause set required or expected under Regulation (EU) No 520/2012 as amended by Implementing Regulation (EU) 2025/1466, Directive 2001/83/EC and GVP, and produce a cited gap report and a reconciliation-log template. The tool is a structuring aid; the agreement owner and QPPV decide.
Requirements. R1 Every rule carries a citation to an article or GVP section and a severity. R2 Keyword detection never overrides a manual "present/missing/n/a" choice. R3 The gap report separates confirmed-missing (manual) from not-detected (keyword scan) so absence of a keyword is never reported as absence of a clause; counts present / missing / not detected / n/a / undetermined. R4 Rules are filtered by relationship type; "all" shows every rule. R5 All processing is local; no network calls after page load. R6 Version and change log are shown; rule wording changes are versioned.
Test evidence (v1.0, 2026-09-24). T1 Text containing "roles and responsibilities", "shall not subcontract … written consent", "agrees to be audited by or on behalf of the MAH and inspected by competent authorities" → R01, R04, R05 detected as present; all other rules reported as "not detected — confirm manually", never as missing. Pass. T2 Manual "n/a" on R31 with type SP → R31 counted as not applicable. Pass. T3 No scan, build report → every applicable rule undetermined; counts sum to the applicable total. Pass.
Known limitations. English keyword detection only. Quotations are abridged (≤30 words) and must be read in the source text. Rules R17 and R27 rest on inspectorate guidance rather than explicit GVP wording. Sections VI.C.2.2.x of GVP Module VI were not re-verified on the review date; timelines are cited to Directive 2001/83/EC Article 107(3), which was. EMA's Q&A on 2025/1466 (Rev 2, Jan 2026) addresses EudraVigilance monitoring only and is not a source for the contract provisions.
Change log. v1.0 (2026-09-24): first release, 35 rules.
When the gap report needs a Danish counterpart
ClinicOps' own engagement terms are drafted to Article 6(3) — defined roles, stated exchange method and timeline, audit and inspection access, no onward subcontracting without written consent — because that is what this checker looks for. If the missing clauses concern a Danish distributor, parallel importer or local-language safety work, that is the bounded work ClinicOps can scope. See the Danish pharmacovigilance capability →