The ULCM identifies medicines for human use whose continued supply is considered a priority for the European Union, as any disruption could have a serious impact on healthcare systems. This update represents the first annual revision of the list and includes the addition and adjustment of several active substances, as well as the inclusion of new ATC codes recognised as critical.
Alongside the revised list, the EMA has updated the associated Q&A document to provide further guidance and support to stakeholders. Medicines included in the ULCM are prioritised for EU-wide actions aimed at strengthening supply chains and minimising the risk of shortages or disruptions.
Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs) are strongly encouraged to review the updated list to determine whether their products are affected and to assess any applicable reporting or preparedness requirements.
MAHs should note that medicinal products included in the ULCM are subject to stricter EMA deadlines, particularly regarding the submission of:
- Manufacturer information
- Marketing and Business Organisation (MBO) data
- Structured pack size data
Ensuring timely compliance with these obligations is essential to support supply continuity and regulatory preparedness across the EU.
How Asphalion Can Support MAHs
Asphalion provides specialized RegOps and data management services to help pharmaceutical and biotech companies comply with EU regulatory requirements, including those related to the Union List of Critical Medicines (ULCM). Our support can include:
- Data collection and validation for regulatory reporting, ensuring accurate submission of manufacturer, MBO, and pack size information
- Preparation and submission of structured data in compliance with EMA requirements
- Ongoing maintenance and updates of regulatory databases to reflect portfolio changes or updated obligations
- Support for regulatory reporting timelines, helping MAHs meet the stricter deadlines associated with ULCM products
By leveraging Asphalion’s RegOps expertise, companies can streamline their data management processes, reduce regulatory risk, and maintain compliance with EU reporting obligations related to critical medicines.
Contact us: [email protected]
For further details, the updated Union List of Critical Medicines and related guidance are available on the EMA website:
EMA – Union List of Critical Medicines
