Renewals · Lifecycle · WRPA
Marketing authorisation renewal – on time and complete
A marketing authorisation is initially valid for five years. The renewal application must reach the authority no later than nine months before expiry – with several products and markets, this quickly becomes a portfolio project.
What I take on
Deadline monitoring
Renewal calendar across products and markets, preparation starting 12–15 months before expiry.
Dossier
Coordinate the Clinical Overview Addendum, consolidate quality and PV data, update the product information.
Submission and liaison
Submission in eCTD format, answering authority questions through to the renewal.
National implementation
Packaging materials, artwork and product information after completion.
EU Pharma Package
What changes with the EU Pharma Package
The new EU Pharma Package provides for abolishing the routine renewal after five years; marketing authorisations would then in principle be valid for an unlimited period. The Council adopted its position on 28 September 2026; the final vote in the European Parliament is still pending. Most rules are expected to apply about 24 months after entry into force – until then, renewals remain mandatory. As of: November 2026.
Next step
Available at short notice for mandates across the EU.
Freelance and interim mandates available now – remote, hybrid or on site in the Frankfurt Rhine-Main region.
Tell me briefly about your project — or book a 30-minute call directly.