Five steps to preparing for the Product Management Service (PMS) of EMA’s SPOR program

Preparing for EMA’s Product Management Service (PMS) in 2025: 5 Essential Steps for Success 

 

The Product Management Service (PMS) database plays a pivotal role in the European Medicines Agency’s (EMA) SPOR program (substance, product, organizations, and referentials). As the foundation for the Identification of Medicinal Products (IDMP) standards in the European Union, PMS enables data standardization, promotes transparency, and enhances the digitalization of European regulatory procedures. In 2025, it will be crucial for pharmaceutical companies to be fully prepared to meet PMS and SPOR requirements. Here is a simplified, step-by-step approach to ensure your organization is ready for the upcoming regulatory changes. 

 

Step 1: Assign EMA Account Administrators 

Before tackling any other requirements, the first step is to assign EMA account administrators. These individuals will be responsible for managing all interactions with the EMA portal, including handling user roles for the PMS system and ensuring the correct permissions for accessing services like centrally authorized products (CAP) and nationally authorized products (NAP). Failure to assign roles correctly can prevent access to essential tools and delay compliance processes. 

 

Step 2: Verify Accurate Migration of Product Data into PMS 

For successful PMS integration, ensure that your product data has been accurately migrated into the system. This includes confirming that product families and related products within the same procedure are properly aligned. Ensuring data consistency across the platform is critical for the smooth operation of the electronic Application Forms (eAFs) and the overall regulatory process. 

 

Step 3: Ensure Compliance with Referentials (RMS, OMS, SMS) 

Compliance with RMS (Reference Member State), OMS (Organization Management System), and SMS (Substance Management System) is a core requirement. Review key terms such as pharmaceutical form, route of administration, and anatomical therapeutic codes (ATC) to ensure they align with the most current standards. Verify the accuracy of your marketing authorization holder (MAH) data and ensure Location_IDs are correctly added to the OMS. Also, check for substance validity and update any outdated terminology to stay compliant with EMA standards. 

 

Step 4: Monitor Union List of Critical Medicines (ULCM) and Pack Size Data 

In 2025, it is essential to stay on top of the Union List of Critical Medicines (ULCM), which includes products with prioritized regulatory requirements. Ensure that complete pack size entries are provided via xEVMPD (European Medicines Verification and Medicines Product Data) and that packaging and manufacturing details are enriched in the PMS interface. National Competent Authorities (NCAs) will report stock levels and expected future demand, making alignment between PMS and these data points critical for accurate shortages monitoring. 

 

Step 5: Strengthen Data Management and Governance Systems 

As the expectations around PMS grow, it is important to proactively prepare all your product data—both for CAP and NAP ensuring that internal systems can handle the increasing demands. Establish solid data governance and management processes to guarantee that your data remains complete, accurate, and accessible. Effective data management will not only help you meet regulatory requirements but also give your company a competitive edge in the long term. 

 

Prepare for a Busy Year with BioBoston Consulting 

The year ahead will be a transformative one for companies working to meet the requirements of the EMA’s Product Management Service (PMS). Following these five steps will streamline your preparation and help you stay compliant with SPOR and IDMP regulations. As these regulations continue to evolve, the time to act is now. 

 

At BioBoston Consulting, we specialize in guiding pharmaceutical companies through regulatory requirements and helping them navigate complex data management systems like PMS, SPOR, and IDMP. Our team of experts can assist you with data governance, system implementation, and ensuring compliance with the latest EMA standards. 

 

Contact BioBoston Consulting today to ensure your company is prepared for 2025 and beyond. Our team is here to help you streamline your regulatory processes, ensuring that your product data is compliant and ready for the challenges ahead.