The EMA PMS is driving strict timelines for MAHs to submit structured product data. Companies can be supported in this activity by PVpharm.
Regulatory Timelines: Clear Deadlines, Limited Time
The EMA has defined a phased roadmap for PMS data submission.
Key milestones:
- June 2026: enrichment of manufacturer data and pack sizes for critical medicines
- December 2026: structured manufacturer data submission across portfolios
- June 2027: completion of pack size enrichment for remaining products
In parallel, MAHs must still comply with legal obligations:
- 15 days to submit new authorisation data
- 30 days to report variations and lifecycle changes
Data must be accurate, structured and submitted on time.
PMS: A New Data Paradigm
PMS represents a major evolution in regulatory data management.
Instead of fragmented systems, PMS introduces:
- A centralised product database
- Full alignment with ISO IDMP standards
- Structured, reusable and consistent product data
This shift allows regulators and MAHs to operate with a single, reliable source of truth, improving traceability, pharmacovigilance and regulatory efficiency. In practice, PMS transforms product data from a compliance obligation into a strategic asset.
By embracing PMS early, MAHs can:
- Accelerate regulatory processes
- Improve data quality and consistency across markets
- Strengthen audit readiness
- Reduce operational inefficiencies
PMS is not just about meeting deadlines — it is about driving digital transformation in Regulatory Affairs.
How PVpharm Supports MAHs
At PVpharm, we help MAHs navigate PMS complexity with a pragmatic, results-driven approach:
- PMS readiness and gap analysis
- Data governance and process design (ISO IDMP aligned)
- Data preparation and enrichment
- Operational support for PUI and API submissions
- Training and change management
- Audit and compliance assurance
Our goal: turn PMS compliance into a scalable, efficient and value-generating process.
please contact us for further information.
