EU Pharmaceutical Legislation Review 2026

The directive that replaces 25 years of EU medicines law

Published mid-2026, fully applicable mid-2028 — but the voluntary phase-in starts now. Here is every major change, and what your regulatory team needs to do about each one.

See all 10 changes Book a demo

New EU
Directivereplaces 2001/83/EC

Equitable access
Available EU-wide, on time
Security of supply
No more critical shortages
One Health
Tackle AMR & environment
A modern system
Digital, paperless, current

Timeline

From entry into force to full application

~24 months

June 2026You are here
Final text adopted and published in the OJEU. The directive enters into force.
H2 2026Act now
Voluntary phase-in begins — ePI go-live for the first product groups. Start portfolio prep now.
2027
Member States transpose the directive into national law. Implementing acts published.
Mid-2028
Full application. New obligations become binding. ePI mandatory for newly authorised medicines.

June 2026H2 20262027Mid-2028

You are here

Final text adopted and published in the OJEU. The directive enters into force.

Act now

Voluntary phase-in begins — ePI go-live for the first product groups. Start portfolio prep now.

Member States transpose the directive into national law. Implementing acts published.

Full application. New obligations become binding. ePI mandatory for newly authorised medicines.

Why this matters now

This is not a 2028 problem

Voluntary phases start this year. Mandatory requirements follow. Companies that plan now comply smoothly — those that wait will scramble.

10+

Distinct compliance obligations across RA, supply chain, PV, labelling and environment

~10k

Individual PIL conversions for a 50-product portfolio across 24 EU languages

24mo

Until full application — less time than one typical packaging validation cycle

All 10 major changes

What's changing — and what to do about it

Each row is a real compliance obligation. Explore the topics we've mapped to Regunaut solutions.

Change Area	Current Regulation	New Obligation	Action Required
1 Electronic product information (ePI) RA / Labelling	Paper PIL in every pack. SmPCs and PILs as static Word/PDF. No central EU repository.	Structured FHIR ePI on EMA platform. QR/NFC on pack. Mandatory for newly authorised medicines.	Plan your PIL transition
2 Environmental risk assessment (ERA) RA / CMC / Environment	ERA required for new MAs but guidance-based. Pre-2005 legacy products effectively exempt.	Mandatory for all products including pre-2005 legacy. Incomplete ERA can block or condition an MA.	Screen your ERA gaps
3 Antimicrobial stewardship plans RA / Regulatory / PV	No statutory ASP required. Prescription status case-by-case. AMR not mandated in PILs.	ASP mandatory at MA application. All systemic antimicrobials Rx-only. AMR card in every PIL.	Build your stewardship plan
4 Shortage prevention & supply chain Supply / Operations	Notification requirements varied by Member State. No EU-wide Shortage Prevention Plan.	6-month advance notice. SPP required for all Rx products. 48-hour risk assessment on request.	Set up shortage prevention
5 MA validity — renewals abolished RA Portfolio	MAs valid 5 years. Formal renewal with benefit-risk re-evaluation required.	MAs valid for unlimited period. No routine renewals — continuous compliance replaces the gate.	Audit your renewal dates
6 Well-established use restrictions RA / BD	WEU available for any substance with 10 years EU use regardless of reference product status.	WEU only if no reference product is authorised or marketed in the EU. Many products must reroute.	Check WEU eligibility
7 Data exclusivity — tiered & conditional BD / Strategy	Simple 8+2+1 model. Time-based exclusivity. No launch obligations tied to protection.	Baseline shortened. Extensions conditional on EU-wide launch, unmet need, comparative data.	Model your exclusivity
8 Variations — electronic & database-driven RA / Submissions	Mix of paper and electronic. All changes require formal variation — including minor admin updates.	Fully electronic mandatory. Certain minor changes via database update — no formal variation.	Streamline your variations
9 Pharmacovigilance — PSUR schedule PV / Safety	PSUR frequency from EURD List or product-specific conditions. No clear statutory schedule otherwise.	Non-EURD: annual 5 years, then 3-yearly for 6 years, then 5-yearly. Full calendar rebuild required.	Rebuild your PSUR calendar
10 Prescription for environmental reasons RA / CMC	Prescription based solely on clinical risk. Environmental profile not a factor in Rx status.	PMT/PBT substances may be required Rx-only as environmental risk minimisation. OTC products face reclassification.	Screen PMT/PBT risk

Electronic product information (ePI)

RA / Labelling

Current Rule: Paper PIL in every pack. SmPCs and PILs as static Word/PDF. No central EU repository.
New Requirement: Structured FHIR ePI on EMA platform. QR/NFC on pack. Mandatory for newly authorised medicines.

Plan your PIL transition

Environmental risk assessment (ERA)

RA / CMC / Environment

Current Rule: ERA required for new MAs but guidance-based. Pre-2005 legacy products effectively exempt.
New Requirement: Mandatory for all products including pre-2005 legacy. Incomplete ERA can block or condition an MA.

Screen your ERA gaps

Antimicrobial stewardship plans

RA / Regulatory / PV

Current Rule: No statutory ASP required. Prescription status case-by-case. AMR not mandated in PILs.
New Requirement: ASP mandatory at MA application. All systemic antimicrobials Rx-only. AMR card in every PIL.

Build your stewardship plan

Shortage prevention & supply chain

Supply / Operations

Current Rule: Notification requirements varied by Member State. No EU-wide Shortage Prevention Plan.
New Requirement: 6-month advance notice. SPP required for all Rx products. 48-hour risk assessment on request.

Set up shortage prevention

MA validity — renewals abolished

RA Portfolio

Current Rule: MAs valid 5 years. Formal renewal with benefit-risk re-evaluation required.
New Requirement: MAs valid for unlimited period. No routine renewals — continuous compliance replaces the gate.

Audit your renewal dates

Well-established use restrictions

RA / BD

Current Rule: WEU available for any substance with 10 years EU use regardless of reference product status.
New Requirement: WEU only if no reference product is authorised or marketed in the EU. Many products must reroute.

Check WEU eligibility

Data exclusivity — tiered & conditional

BD / Strategy

Current Rule: Simple 8+2+1 model. Time-based exclusivity. No launch obligations tied to protection.
New Requirement: Baseline shortened. Extensions conditional on EU-wide launch, unmet need, comparative data.

Model your exclusivity

Variations — electronic & database-driven

RA / Submissions

Current Rule: Mix of paper and electronic. All changes require formal variation — including minor admin updates.
New Requirement: Fully electronic mandatory. Certain minor changes via database update — no formal variation.

Streamline your variations

Pharmacovigilance — PSUR schedule

PV / Safety

Current Rule: PSUR frequency from EURD List or product-specific conditions. No clear statutory schedule otherwise.
New Requirement: Non-EURD: annual 5 years, then 3-yearly for 6 years, then 5-yearly. Full calendar rebuild required.

Rebuild your PSUR calendar

Prescription for environmental reasons

RA / CMC

Current Rule: Prescription based solely on clinical risk. Environmental profile not a factor in Rx status.
New Requirement: PMT/PBT substances may be required Rx-only as environmental risk minimisation. OTC products face reclassification.

Screen PMT/PBT risk

Industry evidence

The industry is already moving

EU countries with active ePI pilots underway as of February 2026

4M+

Medicine packs with ePI in the Belgium/Luxembourg pilot — 97% of hospital pharmacists reported no issues

2028

The year most teams treat as deadline — but voluntary phases and packaging changes start now

“Pharmaceutical manufacturers that treat this as a 2028 problem will find themselves retrofitting packaging infrastructure under regulatory pressure.”
Industry analysis, 2026

Source: EFPIA, Medicines for Europe & AESGP joint survey, February 2026 | EMA Management Board, March 2026

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