Table of Contents
Italy’s FMD Timeline at a Glance
Italy’s transition to full EU Hub integration is well structured and full of deadlines. Here’s the timeline all MAHs should track:
- Until Feb 2027: Stabilization period; use of the “bollino” still allowed
- October 2025: Italy connects to the EU Hub (IOT window)
- Late 2025–Spring 2026: Pilot Phase begins with selected manufacturers, CMOs, wholesalers, and pharmacies
- End of 2026: Progressive rollout in Hypercare mode
- Early 2027: Full stable go-live
Current Requirements for MAHs
MAHs must now:
- Pay Entrance Fee and agree to Annual Fees
- Sign the Onboarding Agreement (same for all companies)
- Ensure readiness for Performance Qualification Testing (PQT)
Already contacted by NMVO Italia? Don’t delay your response. They’re prioritizing early movers.
Milestones Ahead: What Happens After October
- PQT begins for selected MAHs and supply chain partners
- Errors in batch-level data or poor test performance could delay full onboarding
- Hypercare mode = monitored real-time activation for all actors
Why Italy’s Model Is Different
Italy’s system involves:
- EU-level requirements and national verification layers
- Unique product labelling practices (like the historic bollino)
- Additional validation steps for system stability
This layered model means MAHs need specialized support, not just generic EU Hub tools.
How SoftGroup Helps with Onboarding and PQT
We support MAHs entering the Italian market by:
- Automating EU Hub + NMVO Italia workflows
- Preparing documentation and mock tests for PQT
- Handling reporting formats required by both EMVO and Italian stakeholders
We’ve already assisted MAHs in onboarding without delays. Let us show you how.
Is your Italian serialization plan ready for October?
Don’t risk falling behind. Let’s map your onboarding to the right phase.
Book a free demonstration of how SATT PLATFORM can support smooth operations in Italy!
Reference: The EMVS Community Newsletter – EMVO