The PSUR calendar builder
A compliant Art. 108 schedule from your real MA grant dates.
Change #9 of 10 — PV / Safety
Your PSUR calendar was built for a directive that's gone.
Article 108 rewrites the PSUR frequency schedule. Annual, 3-yearly, and 5-yearly cycles shift — and your entire portfolio's reporting ladder needs rebuilding before 2028.
Art. 108 — PSUR Schedule
8 PSURs / 20 yrHow often you file PSURs
MA grant5 yr11 yr20 yr
The portfolio impact
Three tiers means three scheduling logics running simultaneously
A portfolio with products authorised across different years will run annual, 3-yearly, and 5-yearly PSUR cycles at the same time.
3
Reporting tiers in the new schedule: annual, 3-yearly, and 5-yearly
SourceArt. 108
11yr
Threshold where 5-yearly reporting begins — up from the old single 5-year trigger
SourceArt. 108
~60%
Of mature portfolios have products over 5 years needing recalculation
SourceIndustry estimate
What's actually changing
PSUR schedule: old vs new
Article 108 introduces a three-tier frequency ladder replacing the old two-tier model.
Workbench
+ New TaskQuick Tasks/PSUR schedule — current vs new directive
We were told to update our PSUR calendar for the new three-tier schedule. Our current calendar is in Excel and no one built it from the actual MA grant dates.
RegIntel12:39
126.00s256 sources89% confidence2 warnings
2 warnings
Here's the obligation delta for PSUR schedule. The new EU Pharmaceutical Directive replaces Directive 2001/83/EC[1][2] — below is what changes, row by row.
Current vs. new directive4 rows
Change area
Current — 2001/83/EC
New directive — from ~mid-2028
Reporting frequency tiers
Current
2 tiers: annual (0–5yr) then 3-yearly thereafter.
EURD schedule interaction
Current
EURD listings inconsistently applied across portfolios.
New directive
EURD-listed products follow EURD regardless of product age. Art. 108 applies to non-EURD only.[5]
Transition for mature products
Current
Products already on 3-yearly cycle under old framework.
New directive
Products 5–11yr stay on 3-yearly; products over 11yr move to 5-yearly. Dates recalculated from MA grant.[6]
⚠Dates reflect the political agreement text; final deadlines depend on entry into force and the transition period for each obligation.
Synthesised from 20 citations across 256 regulatory sources.
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Where teams fall short
Three calendar gaps that break compliance
Most PSUR calendars were set up once and never revisited. The new schedule changes the logic of how maturity is calculated.
ST
Static calendars
Built on old MA dates
EU
EURD vs non-EURD mixing
One tracker for both
How Regunaut solves it
Five steps to a compliant PSUR programme
From portfolio audit to submission tracking — built for the Art. 108 three-tier schedule.
Pulls grant dates, authorisation type, and EURD status for every product. Classifies each by current Art. 108 tier and flags products where transition triggers a frequency change.
- MA data import from PLMS, registry or CSV
- EURD vs non-EURD automatic detection
- Tier transition flagging at implementation
- Portfolio heatmap: annual / 3-yearly / 5-yearly
Industry evidence
PSUR is now the primary surveillance mechanism
With renewals abolished under Art. 46, regulators rely on PSURs more heavily. Getting the schedule wrong is no longer a minor lapse.
Art.46
Missed PSURs linked to continuous compliance — MA suspension risk without renewal as safety valve
3×
Scheduling logics running simultaneously in mature portfolios: annual, 3-yearly, and 5-yearly
2028
Transition requires recalculation from MA grant date — not just rolling forward existing dates
“We had 47 products on PSUR schedules built before 2020. Rebuilding for Art. 108 wasn't just date recalculation — 12 products needed a completely different submission frequency.”
Common questions
PSUR schedule: what teams ask most
Rebuild your PSUR programme before mid-2028
Recalculate submission dates across your entire portfolio — with EURD override logic, tier detection, and PASS/PAES linkage.
Rebuild your PSUR calendar
Art. 108 Calendar Builder recalculates due dates with tier boundaries and EURD overrides.
Start calendar rebuildAudit your PSUR portfolio
30-minute session identifying products transitioning between tiers at implementation.
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