EU environmental risk assessment (ERA): screening legacy medicines for gaps
Your ERA was optional in 2005. The new rules reach back to it.
Articles 23 to 25 of the agreed directive text tighten environmental risk assessment: four hazard classes to report, an EMA programme for products authorised before 30 October 2005 that never had an ERA, and an inadequate ERA as a ground for refusal (Art. 50). Most regulatory teams don't know which products are exposed.
Legacy products brought into scope
Schematic coverage comparison; widths do not represent portfolio proportions.
The new directive closes the gap in two steps: every new application needs a complete ERA, and legacy products are brought in through EMA's risk-based programme, starting with the ones it flags rather than all at once.
ERA gaps in every legacy portfolio
For products authorised after October 2005, ERAs exist but many were never revisited. For older products, the requirement simply didn't exist.
2005
Cut-off: products authorised before 30 October 2005 that never had an ERA can be called in under an EMA programme
4
Hazard classes the ERA must report: PBT, vPvB, PMT and vPvM, alongside endocrine activity
30mo
For EMA to set up the legacy ERA programme, counted from entry into force
From advisory to obligation
Environmental risk assessment has been required in principle. In practice it carried little weight, and legacy products were never reassessed.
ERA status
Required in new MA applications since October 2005, following EMA's ERA guideline. Environmental risk is not a ground for refusing an MA.
ERA follows EMA's guidelines or justifies divergence, includes risk mitigation measures, and is updated when new information could change its conclusions. An incomplete or unaddressed ERA is a ground for refusal (Art. 23, 50).
Hazard categories
The EMA guideline screens for PBT and vPvB properties.
ERA states whether any ingredient is an endocrine active agent or meets the PBT, vPvB, PMT or vPvM hazard classes of the CLP Regulation (Art. 23(2)). These can also justify prescription-only status (Art. 54(1)(f)).
Legacy products (pre-October 2005)
No retroactive obligation. Products authorised before ERA became a requirement were never asked for one.
EMA sets up a risk-based programme within 30 months of entry into force. Products it identifies as potentially harmful must submit an ERA, and the outcome is published (Art. 24).
ERA monographs
No central substance-level ERA database. Each MAH conducts a full ERA independently, duplicating work across companies.
EMA builds an active substance-based ERA monograph system, starting with a proof-of-concept pilot due within three years of entry into force (Art. 25).
The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.
Find the ERA gaps before a procedure does
Workbench answers the ERA questions your team has today, against the agreed text and EMA's guideline. Atlas keeps the products and dates the answer depends on, and Alerts catches EMA's next step.
What's up next?A third of our portfolio was authorised before 2005 and has no ERA on file. Which products are exposed under the new directive, and what should we do now?
- understanding your question…
ERA screening · 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
Products authorised before 30 October 2005 without an ERA only need one if EMA's risk-based programme identifies them. For applications, an incomplete ERA becomes a ground for refusal, and four hazard classes must now be reported.
2. What changes
3. What to do now
- List the products authorised before 30 October 2005 with no ERA on file.
- Screen their active substances against the PBT, PMT, vPvB and vPvM criteria.
- Plan studies for the likeliest candidates before EMA's programme opens.
Atlas
Keeps every product's registrations and authorisation dates by market, so the products authorised before 30 October 2005 are a list you pull, not an archive search.
See AtlasAlerts
Watches EMA for the legacy ERA programme, guideline revisions and monograph publications, and matches each one to the products it affects.
See AlertsWorkbench
Answers ERA questions against the agreed text and EMA's guideline, and reads your existing ERA documents to say what an update would need, with every point cited.
See WorkbenchA 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets
ERA rules are already tightening
EMA's revised ERA guideline is in force today, and the agreed text gives ERA real consequences.
Rev. 1
Revised EMA ERA guideline, legally effective since 1 September 2024 and replacing the 2006 version
EMA, EMEA/CHMP/SWP/4447/00 Rev. 1
3 years
Deadline for EMA's proof-of-concept pilot of ERA monographs, counted from entry into force
Art. 25(4), agreed directive text
Art. 50
An incomplete or insufficiently substantiated ERA becomes a ground for refusing a national MA
Art. 50(1)(e), agreed directive text
What teams are asking about ERA
Which products need an ERA under the new directive?
Every MA application includes an ERA, as today. Under the agreed text, MAHs must also update the ERA when new information could change its conclusions, and authorities must request updates to older ERAs where information is missing for products potentially harmful to the environment. Products authorised before 30 October 2005 come in through EMA's risk-based programme.
What is PMT and how is it different from PBT?
PBT substances accumulate in organisms and ecosystems. PMT substances persist in the water environment and move through soil into drinking water, but they don't bioaccumulate in organisms. Many pharmaceuticals not classified as PBT may still meet PMT criteria, particularly small, polar molecules.
My product was authorised before October 2005. When does it need an ERA?
Not automatically. EMA must set up a programme within 30 months of entry into force for products authorised before 30 October 2005 that never had an ERA and that it identifies as potentially harmful. If your product is identified, you submit an ERA to EMA and the outcome is published. Screening now tells you which products are likely candidates.
What are ERA monographs and can I use them?
The agreed text tells EMA to build an active substance-based ERA monograph system, starting with a proof-of-concept pilot due within three years of entry into force. How monographs can support new applications will be set by delegated act. Alerts watches EMA for the pilot and for published monographs.
Can a missing ERA actually cause my MA to be refused?
Under Art. 50(1)(e) of the agreed text, a national MA is refused where the ERA is incomplete or insufficiently substantiated, or identified risks are not addressed, unless the applicant justifies this and the authority grants the MA with conditions such as post-authorisation ERA studies. Today, environmental risk is not a ground for refusal.
Related reading
- Each ERA gap becomes an owned task when you start turning regulatory requirements into product action plans.
- Authorisation dates and products per substance come from licence portfolio management in Atlas.
- For a short definition, read the glossary entry on environmental risk assessment (ERA).
- ERA 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: Environmental risk assessment of medicinal products for human use, scientific guideline (EMEA/CHMP/SWP/4447/00 Rev. 1)
- 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 23 to 25 and 50
- EUR-Lex: Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)
- EUR-Lex: Commission Delegated Regulation (EU) 2023/707 adding hazard classes, including PBT, vPvB, PMT and vPvM, to the CLP Regulation
- EUR-Lex: Directive 2001/83/EC on the Community code relating to medicinal products for human use
- 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)
Know where your ERA gaps are before a variation finds them
Most teams learn about an ERA gap once a procedure is already open. Start with the products authorised before 2005 and the substances most likely to meet the new hazard classes.
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