Status on : adopted by the Council; Parliament's final vote expected 23 November 2026.

Legislative timeline
EU pharmaceutical legislation reform

EU pharma package: what changes for marketing authorisation holders

A new directive and a new regulation replace 25 years of EU medicines law. The text published in the Official Journal will fix when each obligation applies. Here are the ten main changes, and what your regulatory team can prepare now.

See all 10 changesLegislative timeline
DirectiveST 7106/2/26 REV 2

Replaces Directive 2001/83/EC

  1. 01ePI (product information)
  2. 02Environmental risk (ERA)
  3. 03Antimicrobial stewardship
  4. 05MA validity / renewals
  5. 06Well-established use
  6. 07Data exclusivity
  7. 08Variations (electronic)
  8. 09PSUR schedule changes
  9. 10Rx for environmental reasons
RegulationST 7105/2/26 REV 2

Replaces Regulation (EC) No 726/2004

  1. 04Shortage prevention plans
What the regulation changes

Legislative status

  1. Council adopted

  2. Parliament second reading opens

  3. Parliament vote

    Expected 23 November 2026

  4. Official Journal publication

    Date not yet set

Full legislative timeline
Why plan now

The substance is agreed, the dates are not

Negotiators settled the content of the directive in December 2025. What the published text will add is when each obligation applies. Mapping the obligations to your products does not have to wait for those dates.

10+

Distinct compliance obligations across regulatory affairs, supply chain, pharmacovigilance, labelling and environment

24

Official EU languages. Product information for a centrally authorised medicine is kept in all of them, so each labelling change multiplies across translations

11 yrs

Overall cap on regulatory protection in the agreed text: a baseline of 8 years of data protection and 1 year of market protection, with conditional extensions

All 10 major changes

What's changing, and what to do about it

Each row links to a detailed page with what changes, what the agreed text says and what to prepare.

1

Electronic product information (ePI)

RA / Labelling
Current rules
Paper PIL in every pack. SmPCs and PILs as static Word/PDF. No legal requirement for an electronic leaflet.
Agreed text
Leaflet in paper and electronically, to standards set by implementing act (Art. 66). Member States may allow electronic-only leaflets.
Plan your PIL transition
2

Environmental risk assessment (ERA)

RA / CMC / Environment
Current rules
ERA required in new MA applications since October 2005, but environmental risk is not a ground for refusal.
Agreed text
Fuller ERA with hazard classes and updates (Art. 23). Inadequate ERA a ground for refusal. EMA programme for pre-October 2005 products it flags (Art. 24).
Screen your ERA gaps
3

Antimicrobial stewardship plans

RA / Regulatory / PV
Current rules
No statutory stewardship plan. Prescription status varies by Member State. No AMR content required in PILs.
Agreed text
Stewardship plan in every antimicrobial MA application (Art. 18). Antimicrobials prescription-only (Art. 54). AMR section at the start of the leaflet (Art. 72).
Build your stewardship plan
4

Shortage prevention & supply chain

Supply / Operations
Current rules
At least two months' notice before interrupting supply (Art. 23a of Directive 2001/83/EC). No EU shortage prevention plan.
Agreed text
Regulation Art. 120: 12 months' notice before permanent cessation, 6 months before a suspension or expected disruption. Prevention plan for every Rx product (Art. 121).
Set up shortage prevention
5

MA validity: unlimited by default

RA Portfolio
Current rules
First MA valid 5 years, then one renewal with benefit-risk re-evaluation before validity becomes unlimited.
Agreed text
MAs valid for an unlimited period from grant (Art. 49). Five years only where limited on safety grounds or granted in exceptional circumstances.
Audit your renewal dates
6

Well-established use restrictions

RA / BD
Current rules
WEU available for any substance with 10 years' EU use, regardless of reference product status (Art. 10a).
Agreed text
WEU closed where a reference product is authorised in the EU and on the EU market at submission (Art. 14). Some products must reroute.
Check WEU eligibility
7

Data and market protection: 8+1, then conditional

BD / Strategy
Current rules
8 years data protection + 2 years market protection, +1 year for a significant new indication. Up to 11 years.
Agreed text
8 + 1 baseline. +1 year for unmet need or a qualifying new active substance, +1 for a new indication. Cap 11 years (Art. 83 to 84).
Model your exclusivity
8

Variations: electronic & database-driven

RA / Submissions
Current rules
Type IA, IB and II under Regulation (EC) No 1234/2008, revised from January 2025 (annual Type IA update, PACMPs).
Agreed text
Electronic applications in EMA formats; some changes as database updates (Art. 94). Categories set by delegated act.
Streamline your variations
9

Pharmacovigilance: PSUR schedule

PV / Safety
Current rules
Frequency set in the MA or by the EURD list. Default for older MAs: 6-monthly for 2 years, yearly for 2, then 3-yearly.
Agreed text
New default: yearly for 5 years on the market, 3-yearly for 6, then 5-yearly (Art. 112). EURD changes take effect after 4 months.
Rebuild your PSUR calendar
10

Prescription for environmental reasons

RA / CMC
Current rules
Prescription based solely on clinical criteria. Environmental profile not a factor in Rx status.
Agreed text
PBT, vPvB, PMT or vPvM substances can be made Rx-only as an environmental risk minimisation measure (Art. 54(1)(f)). OTC products may be reviewed.
Screen PMT/PBT risk

Preparing before the dates are fixed

Most of the preparation does not depend on the final application dates. For each change above, the useful first step is to work out which of your products, procedures and markets it touches, who owns the follow-up, and what evidence or data you will need. Regunaut supports this by turning directive obligations into product-level actions.

The remaining steps (the European Parliament's vote, publication in the Official Journal, then implementing acts, EMA guidance and national transposition) will each change what is required and when. Regunaut Alerts monitors EMA, the Commission and national authorities and flags the updates that affect your product classes.

Where things stand

The groundwork is already under way

Regulators are building the systems the new rules rely on before the texts are published.

4

Member States in the EMA and national authority ePI pilot (Denmark, the Netherlands, Spain and Sweden), July 2023 to August 2024

~75%

Of medicinal products authorised in the EU are covered by the second version (2024) of the Union list of critical medicines

Rev. 1

Revised EMA environmental risk assessment guideline, legally effective since 1 September 2024

Sources: EMA ePI pilot report (December 2024); EMA, Union list of critical medicines; EMA guideline EMEA/CHMP/SWP/4447/00 Rev. 1.

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.

  1. Council of the EU: Position at first reading on the Directive on the Union code relating to medicinal products for human use, adopted 28 September 2026 (ST 7106/2/26 REV 2)
  2. Council of the EU: Position at first reading on the Regulation laying down Union procedures for the authorisation and supervision of medicinal products, adopted 28 September 2026 (ST 7105/2/26 REV 2)
  3. Council of the EU: 'Pharma package': Council and Parliament reach a deal (press release, 11 December 2025)
  4. Council of the EU: The pharma package, new EU rules on medicines (policy page)
  5. European Commission: Reform of the EU pharmaceutical legislation
  6. EUR-Lex: Procedure 2023/0132/COD, Directive on the Union code relating to medicinal products for human use (COM(2023) 192)
  7. EUR-Lex: Procedure 2023/0131/COD, Regulation on Union procedures for the authorisation and supervision of medicinal products (COM(2023) 193)

See where your portfolio stands

Ten changes reach different parts of a portfolio. Start with the ones that touch your products first.

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