*In September 2024, read-only functionality was made available for CAPs and non-CAPs to NCAs holding both Human and Veterinary products, whereas in December 2024 the same functionality was made available also for Human-only NCAs.
This marks an important step towards making structured, standardised, and consistent human authorised medicinal product data available for both human and machine interaction across the European Medicines Regulatory Network.
Please refer to the updated PMS roadmap for an overview of key ongoing and upcoming actions for MAHs.
Training and support for the PUI and API use:
Upcoming training session: EMA is organising two public webinars in October 2025 to provide an overview of the PUI and API releases:
PMS PUI Training: Product data submission & bulk edit made easy – 6 October 2025 (10:00 -12:00 CEST). The PMS team will host a webinar to provide insights and training on the new bulk edit functionality for MAHs, including a recap of PUI key features. Register here, and consult the event web page for further information.
Unlocking PMS API potential: Edit functionality training for MAHs – 16 October 2025 (10:00 -11:30 CEST). The PMS team will host a webinar to provide insights and training on the Application Programming Interface (API) edit functionalities for MAHs. Register here, and consult the event web page for further information.
You can consult the following PMS guidance documents on the PLM Portal:
PMS Product UI registration guide: support in completing the steps needed to gain access to the PUI.
PMS Product UI navigation guide: support in navigating across the pages of the PUI.
European Medicines Agency Write PMS API Implementation Guide: comprehensive resource for stakeholders who are working to adopt and implement healthcare standards on FHIR (Fast Healthcare Interoperability Resources)