The Spanish Agency of Medicines and Health Products (AEMPS) has announced a major regulatory update: starting July 1, 2025, the Organization Management Service (OMS) will be mandatory for all new marketing authorization applications and variations processed through the national procedure.
- What does change with this new requirement?
• The use of OMS will be compulsory for all new national marketing authorization applications and modifications.
• The requirement extends to national codes for centrally authorized medicines and their variations.
• While OMS use is not mandatory for decentralized and mutual recognition procedures, AEMPS recommends its adoption due to its regulatory and operational benefits. - What is OMS and Why is it important?
OMS is part of the SPOR database, developed by the European Medicines Agency (EMA) to implement the ISO IDMP standard for medicinal product identification. It ensures the precise and standardized identification of organizations involved in pharmaceutical regulatory activities in the EU. - Key benefits of OMS:
• Ensures accurate and standardized regulatory data across EMRN and pharmaceutical industries, facilitating a precise and univocal identification of the companies that participate in the registration of medicines in the European Union.
• Prepares companies for the transition to digital forms, as future application forms will replace eAF PDFs and require organizations to be registered in OMS.
• Enhances data quality and consistency, allowing an adequate exchange of information and alignment with other systems, such as PMS (Product Management Service) and ESMP (European Shortages Monitoring Platform), thus ensuring the unequivocal and unique identification of both the medicines and the organizations that may be involved in the marketing authorization. - AEMPS public information session
To provide further details on the requirements and advantages of OMS, AEMPS will hold a public information session on March 27, 2025. The session will also include updates on the ISO IDMP implementation and its impact on regulatory procedures.
📌 Session details:
• Date: March 27, 2025
• Time: 10:00 – 12:00 CET
• Format: Online
🔗 Register for the AEMPS public information session:
AEMPS Session Registration - How can PVpharm help?
At PVpharm, we understand the challenges of adapting to new regulations. Our team of regulatory experts is ready to assist pharmaceutical companies in their transition to mandatory OMS usage.
PVpharm’s Services for OMS new requirements include:
• OMS Registration
• Guidance/training for OMS registration
• Assistance in any issue during OMS Registration
Ensure a smooth transition to OMS and maintain full compliance with European regulations.
please contact us for further information.
