Last week, during the Q3 System Demo, the EMA shared important updates:
- During this Q4 2024, the PUI (Product User Interface) will be released, enabling access to CAPs and NAPs data on the PMS platform. In 2025, the API (Application Programming Interface) will be available.
- Regarding ESMP, whose data is provided by PMS, the EMA plans to conduct a UAT session from October 7th to 16th with MAHs, to provide examples of routine shortage reporting.
- The readiness report for MAHs on shortages will be available at the end of November, 2024, while the remaining reports will be available between January and February 2025.
From Asphalion, we can provide you with support in:
- xEVMPD Maintenance: Analyze 3rd ACKs and submit pack size structure data through xEVMPD.
- Data Enrichment in compliance with ISO IDMP
- Review your product in PMS
- Correct your data in PMS
- Management of new tools on behalf of MAHs (PMS, RPM, eAF, ePI,…).
You can contact us at: [email protected]
