On 30 June, we reached a major regulatory milestone.
At Asphalion, we supported some leading international pharmaceutical companies in successfully completing, within the deadline established by the European Medicines Agency (EMA), the submission of Manufacturers, Manufacturing Business Operations (MBOs), and Structured Data of Pack Sizes in the Product Management Service (PMS) for all medicinal products included in the Union List of Critical Medicines (ULCM).
This achievement reflects the dedication of our team and the close collaboration with these companies, ensuring full compliance with EMA requirements within the established timeline.
The next regulatory milestone is already underway.
Marketing Authorisation Holders (MAHs) that have not yet started this process should begin collecting and reviewing the required data as soon as possible to meet the next EMA deadline in December 2026. During this phase, MAHs will be required to submit Manufacturers, Manufacturing Business Operations (MBOs), and Structured Data of Pack Sizes for the remainder of their medicinal product portfolios.
Starting early helps identify potential data gaps, improve data quality, and ensure timely compliance with the upcoming regulatory requirements.
Important reminder: Whenever an approved variation results in changes to Manufacturers, Manufacturing Business Operations (MBOs), or Structured Data of Pack Sizes, MAHs are required to update the corresponding information in the Product Management Service (PMS) within 30 days of the variation approval, in accordance with EMA guidance.
At Asphalion, we continue to support pharmaceutical companies in navigating these evolving regulatory requirements, enabling efficient data management and helping ensure ongoing compliance with EMA obligations.
Can we help? Contact us at: [email protected]
