EU marketing authorisation validity: unlimited by default, routine renewals gone
Your renewals are going. Your obligations aren't.
Article 49 of the agreed directive text (and Article 18 of the Regulation for centralised products) makes marketing authorisations valid for an unlimited period from grant. Authorities can still limit validity to five years on safety grounds, and MAs granted in exceptional circumstances stay at five years. The renewal gate that forced periodic review largely goes; the obligations that follow grant don't.
Renewal gate vs. indefinite validity
Removing the renewal doesn't remove the work
The 5-year renewal was a forcing function. Without it, that discipline must be built into continuous lifecycle management.
∞
Default validity of new EU MAs, national and centralised, from first grant
5 years
Validity where an authority limits it on safety grounds, or for MAs granted in exceptional circumstances. Renewal is then due nine months before expiry
Art. 92(4)
Authorities can ask at any time for data showing that the benefit-risk balance remains favourable
From periodic renewal to continuous compliance
Regulators haven't reduced scrutiny. They've moved it into continuous obligations throughout the product lifecycle.
MA validity period
First MA valid for 5 years. After one renewal, unlimited, unless the authority requires one further 5-year renewal on pharmacovigilance grounds.
Unlimited from grant by default. Five years only where limited on safety grounds or granted in exceptional circumstances (Art. 49).
Renewal procedure
Consolidated renewal file at least nine months before expiry, with updated quality, safety and efficacy data. Significant resource investment.
No routine renewal. Where validity is limited, renewal rests on a re-evaluation of benefit-risk; once renewed, the MA is unlimited (Art. 49(4)).
Post-approval commitments
Commitments tracked partially through renewal. Gaps common, some outstanding for years.
Conditions recorded in the MA and followed through variations, PSURs and authority requests. Authorities can suspend, revoke or vary MAs (Art. 198).
Benefit-risk review
Formal assessment at renewal. Between renewals, reactive review driven by safety signals or PSUR outcomes.
Authorities can request benefit-risk data at any time (Art. 92(4)). PSURs remain the main structured review point (Art. 111 to 116).
The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.
Track what replaces the renewal
Workbench answers renewal and validity questions against the agreed text, product by product. Atlas keeps expiry dates, PSURs and commitments on one timeline, and Alerts catches new EMA guidance.
What's up next?We have 14 renewals due in the next 18 months and routine renewals are going away under the new directive. Which do we still need to file, and what replaces them?
- understanding your question…
MA validity · 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
Renewals due before the new rules apply are still filed under current rules; MAs expiring after follow the Art. 49 procedures. New MAs are unlimited by default, and oversight moves to PSURs, variations and benefit-risk requests.
2. What changes
3. What to do now
- File the renewals due before the new rules apply under current rules.
- Record each product's MA type and outstanding post-approval commitments.
- Put PSUR dates on the calendar as the new periodic checkpoint.
Atlas
Holds authorisation expiry per product and market, and keeps PSURs, variations and post-approval commitments on one timeline with an owner and status, so nothing waits for a renewal to surface it.
See AtlasWorkbench
Answers validity and transition questions against Articles 49 and 221, reads your MA terms to say which products still need a renewal file, and helps prepare the renewals that remain.
See WorkbenchAlerts
Watches EMA and national authorities for new guidance on validity and renewals, matches each notice to the licences it affects, and proposes one action with an owner and date.
See AlertsA 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets
Renewal work falls away, oversight stays
Teams will welcome less renewal workload. The risk is reading this as 'less work' when scrutiny has been made continuous.
9 months
Lead time for today's renewal file before the 5-year expiry, the workload that falls away for most new MAs
Art. 24, Directive 2001/83/EC
Art. 221(7)
Transitional rule: for MAs that expire after the new rules apply, renewal follows the Art. 49 procedures
Agreed directive text
Art. 198
Authorities keep the power to suspend, revoke or vary an MA at any point in its life
Agreed directive text
What teams are asking about MA validity changes
Does unlimited validity apply to products already on the market?
The agreed text applies to products authorised under Directive 2001/83/EC (Art. 221(3)), and for products whose MA expires after the new rules apply, renewal follows the Art. 49 procedures (Art. 221(7)). Renewals due before that date are still filed under current rules. Check each product's MA terms against the published text.
If renewals are gone, what happens at the 5-year mark?
Nothing procedurally for an unlimited MA. Oversight continues through PSURs, variations and requests for benefit-risk data, which authorities can make at any time (Art. 92(4)).
What happens to conditional MAs?
Conditional MAs are governed by the Regulation and keep their own rules, with specific obligations to complete. Track each obligation's deadline until the MA converts to a standard authorisation.
We have 200 products with renewal dates in the next 5 years. What do we do?
Categorise each: expiry before or after the date the new rules apply, MA type, and outstanding commitments. Atlas holds authorisation expiry per product and market, so the list comes from one record; revisit it once the published act fixes the dates.
How does PSUR replace the renewal as a lifecycle gate?
PSUR becomes the main structured review. Frequency is set in the MA or the EURD list; for older MAs with no set frequency, the agreed text's default is yearly for five years after placing on the market, three-yearly for six years, then five-yearly (Art. 112(2)). PSUR assessment is the main route to regulatory action.
Related reading
- Replacing renewal dates with a continuous calendar is the core of regulatory lifecycle planning.
- MA dates, types and conditions per product come from licence portfolio management in Atlas.
- For the reporting that becomes the main checkpoint, read the glossary entry on periodic safety update reports (PSURs).
- Major changes to an unlimited MA still go through a Type II variation.
- MA validity 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 49, 92, 198 and 221
- 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), Article 18
- European Medicines Agency: Renewal and annual re-assessment of marketing authorisation
- European Parliament: Deal on comprehensive reform of EU pharmaceutical legislation (press release, 11 December 2025)
- EUR-Lex: Directive 2001/83/EC on the Community code relating to medicinal products for human use (Article 24, current renewal rules)
- 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)
Sort your renewals before the new rules apply
Renewal dates stop being the checkpoint, but the obligations behind them stay. Start with the MAs that expire around the date the new rules apply.
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