As part of the ongoing efforts to enhance transparency and monitoring of medicine shortages in Europe, the ESMP has outlined crucial steps that must be completed by all Marketing Authorization Holders (MAHs) by February 2025.
Actions Required by MAHs:
To ensure compliance and to assist in the effective functioning of the ESMP, the following actions are required from MAHs:
- Submission to xEVMPD
- Data Examination
- Data Enrichment
Recent Update for MAHs:
MAHs will now need to submit additional information:
- For Centrally Authorized Products (CAPs) and Non-CAPs authorized at pack size level, submission to the xEVMPD is required.
- For non-CAPs authorized at the medicinal product level, submission is mandatory for products on the Union List of Critical Medicines and optional for others.
Recommendations:
In the event of a crisis, information on pack sizes that are not currently on the market will be requested. Therefore, our recommendation is to proactively submit details for all pack sizes for all your authorized products.
For any questions or assistance with submissions, contact us at: [email protected]
