The Product Management Service (PMS) database is a core element in the European Medicines Agency’s (EMA) four-component SPOR program (substance, product, organisations and referentials). Together, these domains support the implementation of Identification of Medicinal Product (IDMP) standards in the European Union.
EMA’s overarching goal is to establish data standardization and facilitate the exchange of data across the network of European regulators, drive greater transparency and support digitalization of European regulatory procedures. PMS is the foundation for all product data re-use across other EMA and, eventually, national competent authority services such as electronic application forms (eAF), electronic product information (ePI) and the European Shortages Monitoring Platform (ESMP).
Many small and even mid-size companies have faced challenges with the requirements and goals of PMS. However, in 2025 it will be essential to have the core elements in place to be fully SPOR ready. Having a checklist of steps can take the complexity out of preparing for PMS, SPOR and IDMP.
The following 5 steps will help you prepare for the year ahead:
Step 1: Assign EMA account administrators[1]. The admins will support in all other EMA portal needs and provide access for the various roles, such as making sure your user roles are assigned to support PMS and centrally authorized products and nationally authorized (CAP/NAP) eAFs already available via the PLM Portal. Without assigning the user roles to the correct people, services cannot be accessed and used.
Step 2: Check that your product data has been accurately migrated into the PMS[2]. It is important to make sure the data is consistent on product families and those products belonging to the same procedure(s) in order to guarantee smooth use of electronic Application Forms.
Step 3: Check compliance with RMS, OMS and SMS. Are you in compliance with current terms (especially for pharmaceutical form, route of administration and anatomical therapeutic codes (ATC)) with your referentials?[3] Have you checked your marketing authorization holder (MAH) entities and added unique identities (Location_ID) for the OMS?[4] Have you checked that your substances are not invalid and made sure the more current term has been used?[5]
Step 4: Make sure that you are on top of the products included in the Union List of Critical Medicines (ULCM) and their prioritized requirements. That includes complete pack size entries via xEVMPD and enrichment of packaging and manufacturing data in the PMS UI (or API) before the end of 2025. National stock and expected future demand need to be reported by NCAs via the shortages monitoring platform and therefore need to be aligned and matched with the data on products coming from PMS[6].
Step 5: Take proactive steps to prepare all your product data, both for CAPs and NAPs, for the increasing number of expectations authorities will have in order to get PMS data complete. Make sure you have internal systems in place to support the data, and have data management and governance processes defined. Complete and accurate product data will also be your asset!
The year ahead will be a busy one for companies as they work to meet EMA requirements for the PMS. Taking a step-by-step approach will help you to make these processes easier.
About the author:
Hanna Saari is Service Line Lead of Regulatory Informatics Services at PharmaLex. Hanna has 20 years of regulatory experience in industry, with a global pharmaceutical company, national competent authorities, and as a consultant.
[1] EMA Account Management | User Administrator Guide, EMA. https://register.ema.europa.eu/identityiq/help/useradmin.html
[2] Product Management Service (PMS) – Frequently Asked Questions (FAQs), EMA. product-management-service-pms-frequently-asked-questions-faqs_en.pdf (europa.eu)
[3] Referentials Management Service (RMS), EMA. Referentials Management Service (RMS) | European Medicines Agency (EMA) (europa.eu)
[4] Organisation Management Service (OMS), EMA. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/organisation-management-service-oms
[5] List of substances, IRIS, EMA. List of substances · IRIS (europa.eu)
[6] European Shortages Monitoring Platform (ESMP) Implementation Guide for National Competent Authorities, EMA, Nov 2024. https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-implementation-guide-national-competent-authorities_en.pdf
