EU antimicrobial stewardship requirements: plans, prescription status and leaflet rules
AMR has moved from your brand team to your regulatory dossier.
Under Articles 18, 54 and 72 of the agreed directive text, every antimicrobial MA application includes a stewardship plan, antimicrobials become prescription-only (with a possible waiver for topical use), and the package leaflet opens with an AMR section. Priority antimicrobials can also earn a transferable data exclusivity voucher under the new Regulation.
Antimicrobial MA dossier obligations
A stewardship plan is part of the dossier
A stewardship plan is part of the MA application. Regulators review it, publish information on it and can impose obligations if it falls short.
Art. 18
Every antimicrobial MA application includes a stewardship plan; authorities impose obligations if its measures are unsatisfactory
31–39k
Attributable deaths a year in the EU/EEA from infections with antibiotic-resistant bacteria (2016 to 2020 estimates)
12mo
Extra regulatory data protection a transferable voucher adds to one authorised product, earned by developing a priority antimicrobial
From voluntary commitments to dossier obligations
Stewardship has been voluntary for two decades. The agreed text makes it part of the MA.
Stewardship plan
No formal stewardship plan in the MA dossier. Industry initiatives are voluntary with no regulatory review.
Plan in every antimicrobial MA application: risk mitigation measures, resistance monitoring and reporting, and checks on effectiveness. Authorities impose obligations if measures fall short (Art. 18, Annex I).
Prescription status
Generally Rx-only, but OTC possible in some Member States for specific products.
Antimicrobials (antibiotics, antivirals, antifungals, antiprotozoals) subject to medical prescription. Member States may waive this for topical use (Art. 54(1)(e) and 54(6)).
Patient leaflet content
Standard PIL structure. No specific AMR messaging required.
A section at the start of the leaflet with the global AMR symbol and information on resistance, appropriate use and disposal. Paper awareness card where a Member State allows electronic-only leaflets (Art. 72).
Pack size and environment
Pack sizes set commercially. The ERA does not assess resistance.
Packs for direct dispensing must match usual posology and treatment duration (Art. 18(3)). The ERA evaluates AMR selection risk across manufacturing, use and disposal (Art. 23(4)).
The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.
Map stewardship duties across your antimicrobials
Workbench answers stewardship, prescription status and leaflet questions against the agreed text. Atlas keeps each antimicrobial's registrations and tasks in one place, and Alerts catches the guidance that follows.
What's up next?We have six oral antibiotics on the market and none has a formal stewardship plan. What does the new directive require of them, and where do we start?
- understanding your question…
Antimicrobial stewardship · 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
A stewardship plan becomes part of every antimicrobial MA application, and authorities can impose obligations if its measures fall short. Antimicrobials also become prescription-only, and the leaflet opens with an AMR section.
2. What changes
3. What to do now
- List each antimicrobial and the markets where it is sold without prescription.
- Draft a plan for one product against the elements listed in Annex I.
- Check current leaflets for resistance, appropriate use and disposal content.
Atlas
Keeps each antimicrobial's registrations across markets in one record, and puts plan drafting, leaflet updates and any reclassification on the timeline with an owner and status.
See AtlasAlerts
Watches EMA and the national authorities for stewardship guidance and leaflet notices, matches each one to the antimicrobials it affects, and proposes an action with an owner and date.
See AlertsWorkbench
Answers stewardship and prescription status questions against the agreed text, and reads your SmPCs and leaflets to say what a plan or AMR section would need, with every point cited.
See WorkbenchA 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets
Commitments become regulatory obligations
Stewardship pledges made since the 2016 UN political declaration on AMR now have a place in the MA dossier.
10M
Annual deaths projected from AMR by 2050 if current trends continue
Review on Antimicrobial Resistance (O'Neill), 2016
2024
Latest WHO bacterial priority pathogens list, which EMA must take into account when assessing priority antimicrobials for the voucher
WHO; Regulation Art. 41(3), agreed text
Day one
The voucher provisions apply from entry into force, not after the 24-month transition that covers most of the package
Regulation Art. 187, agreed text
What teams are asking about stewardship requirements
Which products require an antimicrobial stewardship plan?
Every antimicrobial in the directive's sense: medicinal products with a direct action on micro-organisms used to treat or prevent infections, including antibiotics, antivirals, antifungals and antiprotozoals. The requirement attaches to the MA application (Art. 18).
What does a stewardship plan actually have to contain?
Annex I of the agreed text lists risk mitigation measures to limit resistance from use, prescription and administration; how the MAH will monitor and report resistance; and measures to monitor the effectiveness of stewardship. Detailed guidance is expected from EMA.
Can we use our company AMR roadmap as the plan?
Not directly. Roadmaps are portfolio-level public commitments. A stewardship plan is product-specific, structured for regulatory assessment, with measurable commitments and resistance reporting.
What goes in the leaflet's AMR section?
A section at the beginning of the package leaflet with the global AMR symbol, product-specific information, and information on resistance and appropriate use and disposal (Art. 72). Implementing acts will set how the symbol is included. Where a Member State allows electronic-only leaflets, the same information goes on a paper awareness card.
My antifungal is OTC in some markets. What happens?
Under Art. 54(1)(e), antimicrobials become prescription-only, so an OTC systemic antifungal would need reclassification, a PIL update and packaging changes. Member States may waive prescription for topical use (Art. 54(6)).
Related reading
- Each new obligation becomes an owned task per product when you start turning regulatory requirements into product action plans.
- New EMA, ECDC and WHO guidance reaches the right product owner through regulatory change monitoring with Alerts.
- The transferable data exclusivity voucher sits in the companion EU pharmaceutical Regulation.
- Antimicrobial stewardship 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.
- 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 18, 23, 54, 72 and Annex I
- Council of the EU: Regulation laying down Union procedures for the authorisation and supervision of medicinal products, Council position at first reading, 28 September 2026 (ST 7105/2/26 REV 2), Articles 41 to 45
- European Parliament: Deal on comprehensive reform of EU pharmaceutical legislation (press release, 11 December 2025)
- ECDC: Health burden of infections with antibiotic-resistant bacteria in the EU/EEA, 2016–2020
- World Health Organization: WHO bacterial priority pathogens list, 2024
- 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 stewardship duties land before the directive applies
Stewardship plans, prescription status and leaflet changes all land on the same products. Start with the antimicrobials sold without prescription in some markets and the leaflets that need an AMR section.
Book a stewardship walkthrough
30 minutes on your own portfolio: which antimicrobials the new rules reach, and how Atlas, Alerts and Workbench keep track of them.
Book a demoAsk Workbench yourself
Put your stewardship and leaflet questions to Workbench and get answers that cite the agreed text and guidance.
Try for free