EU PSUR frequency changes: the new default schedule and EURD rules
Your PSUR calendar was built for rules that are changing.
Article 112 of the agreed directive text keeps PSUR frequency set in the MA or by the EURD list, but changes the default ladder for older MAs with no set frequency: yearly for five years after placing on the market, three-yearly for six years, then five-yearly. EURD changes would take effect after four months instead of six. Calendars built on assumptions rather than each product's actual basis will drift.
How often you file PSURs
Three scheduling bases running side by side
A portfolio mixes MA-specified frequencies, EURD-listed substances and older MAs on the default ladder. Each counts from a different date.
3
Tiers in the agreed default ladder for MAs with no set frequency: yearly, three-yearly and five-yearly
11yr
Point after first placing on the market where the default ladder moves to five-yearly reporting
4mo
Until a change to the EURD list takes effect, down from six months today
PSUR schedule: old vs new
Article 112 replaces the default ladder and tightens the EURD change lead time. Most other PSUR mechanics carry over.
Default frequency (no set frequency)
For older MAs without a set frequency: six-monthly for two years after placing on the market, yearly for two years, then three-yearly (Art. 107c(3)).
Yearly for five years after placing on the market, three-yearly for the next six, then five-yearly. Six-monthly until first placed on the market (Art. 112(2)).
EURD schedule interaction
EURD frequencies override the default; changes take effect six months after publication.
EURD list still harmonises frequencies by substance; changes take effect four months after publication (Art. 112(4) to (7)).
Who submits and what
Generics and well-established use products exempt from routine PSURs unless required or requested.
Same exemption for generics and bibliographic applications (Art. 111(4)). PSURs must split sales and volume data between EU and non-EU (Art. 111(1)).
Renewal interaction
PSUR overlapped with the 5-year renewal as a periodic checkpoint.
MAs unlimited by default (Art. 49). PSUR becomes the main structured periodic review.
The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.
Know which PSUR schedule each product follows
Workbench answers PSUR schedule questions against the agreed text and GVP Module VII. Atlas keeps the dates each schedule counts from, and Alerts catches EURD list changes as EMA publishes them.
What's up next?Our PSUR calendar is in Excel and nobody has checked which products follow the EURD list and which follow the default ladder. What changes under Art. 112, and where do we start?
- understanding your question…
PSUR schedule · current rules against the agreed text
- Based on the agreed text, which is not yet in the Official Journal. Dates count from entry into force.
1. Short answer
Frequencies set in the MA or by the EURD list still apply. Only MAs with no set frequency move to the new default ladder, and EURD changes take effect after four months instead of six.
2. What changes
3. What to do now
- Record each product's basis: MA-specified, EURD-listed or default ladder.
- Count default-ladder products from first placing on the market, not grant.
- Check which products cross the 5-year or 11-year boundary as the rules apply.
Atlas
Keeps grant and launch dates per product and market, and puts each PSUR on the timeline with an owner and status, so the date every schedule counts from is on record.
See AtlasAlerts
Watches EMA for EURD list changes and new PSUR guidance, matches each one to the licences it affects, with the notice cited, and proposes one action with an owner and date.
See AlertsWorkbench
Answers PSUR schedule questions against Articles 111 to 116 and GVP Module VII, and asks whether a product is EURD-listed or MA-specified when the answer depends on it.
See WorkbenchA 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets
PSUR becomes the main periodic checkpoint
With routine renewals gone, regulators lean more on PSURs. Getting the schedule wrong is no longer a minor lapse.
Art. 49
MAs valid for an unlimited period by default, so PSURs carry more of the periodic oversight
Agreed directive text
3×
Scheduling bases in a mature portfolio: MA-specified, EURD-listed and the default ladder
Art. 111(1)
PSURs must separate sales and volume data generated in the EU from those generated outside it
Agreed directive text
PSUR schedule: what teams ask most
When does the new schedule apply, and from which date do tiers count?
The agreed text provides for Art. 111 to 116 to apply 24 months after entry into force; the calendar date will be fixed by the published act. Under the default ladder, tiers count from first placing on the market; MA-specified frequencies count from the grant date. Transitional guidance for products mid-cycle is likely.
Do EURD-listed products use the default ladder or EURD frequencies?
EURD-listed products follow the EURD timetable. The default ladder only applies where neither the MA nor the EURD list sets a frequency. Changes to the EURD list take effect four months after publication under the agreed text.
If a product has been on the market for 7 years when the rules apply, which tier is it in?
If it follows the default ladder, it sits in the three-yearly tier (years 6 to 11 after placing on the market), and moves to five-yearly after year 11. How products mid-cycle switch from today's ladder will depend on transitional guidance.
Does the new schedule apply to nationally authorised products?
Yes. The PSUR rules cover nationally and centrally authorised products, and the default ladder also applies to products authorised in only one Member State where no harmonised EURD frequency exists (Art. 112(3)). EURD listings continue to govern listed substances.
With renewals gone, does PSUR replace the renewal review?
Not entirely. PSURs cover benefit-risk under Art. 111, but authorities can request benefit-risk data at any time (Art. 92(4)) and trigger reviews outside the PSUR cycle. PSUR is the main periodic mechanism, not the only one.
Related reading
- PSUR windows sit alongside variations and commitments in regulatory lifecycle planning.
- Grant and launch dates per product and market come from licence portfolio management in Atlas.
- For a short definition, read the glossary entry on periodic safety update reports (PSURs).
- A PSUR outcome that changes the product information usually leads to a Type II variation.
- Why PSURs matter more now is covered in unlimited marketing authorisation validity.
- PSUR scheduling is one of ten changes covered in our guide to the new EU pharmaceutical directive.
- Dates that depend on publication are tracked on the EU pharma package legislative timeline.
Sources
Article numbers refer to the Council's position at first reading of 28 September 2026 (ST 7106/2/26 REV 2 for the directive, ST 7105/2/26 REV 2 for the regulation), which reflects the political agreement of December 2025. Numbering may change in the act published in the Official Journal.
- European Medicines Agency: Periodic safety update reports (PSURs)
- European Medicines Agency: Introductory cover note to the list of European Union reference dates and frequency of submission of PSURs (EURD list)
- European Medicines Agency: Guideline on good pharmacovigilance practices (GVP), Module VII, Periodic safety update report
- Council of the EU: Directive on the Union code relating to medicinal products for human use, Council position at first reading, 28 September 2026 (ST 7106/2/26 REV 2), Articles 111 to 116
- EUR-Lex: Directive 2001/83/EC on the Community code relating to medicinal products for human use (Articles 107b and 107c)
- Council of the EU: 'Pharma package': Council and Parliament reach a deal (press release, 11 December 2025)
- Council of the EU: The pharma package, new EU rules on medicines (policy page)
- European Commission: Reform of the EU pharmaceutical legislation
- EUR-Lex: Procedure 2023/0132/COD, Directive on the Union code relating to medicinal products for human use (COM(2023) 192)
- EUR-Lex: Procedure 2023/0131/COD, Regulation on Union procedures for the authorisation and supervision of medicinal products (COM(2023) 193)
Check your PSUR schedule before the new rules apply
Calendars set up once and never revisited will drift. Start with the products on the default ladder and those that cross a tier boundary at transition.
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