EMA Guidance: Product Management Services (PMS) – Electronic Submission of Medicinal Product Information

As regulatory systems become increasingly digital, standardized medicinal product data has become essential for improving regulatory efficiency and ensuring consistent information across the European medicines network. To support this transition, the European Medicines Agency (EMA) published the guidance Product Management Services (PMS) – Implementation of ISO Standards for the Identification of Medicinal Products (IDMP) in Europe – Chapter 3: Process for the Electronic Submission of Medicinal Product Information.

The guidance explains how medicinal product information should be electronically submitted, updated, and maintained throughout its lifecycle using Product Management Services (PMS) in line with ISO Identification of Medicinal Products (IDMP) standards.

By adopting a harmonized approach, the guidance aims to improve data quality, interoperability, and digital collaboration across the European Economic Area (EEA).

Why ISO IDMP and PMS Matter

ISO IDMP standards provide a standardized framework for identifying and describing medicinal products, allowing consistent exchange of information between marketing authorisation holders (MAHs), national competent authorities (NCAs), and the EMA. The guidance explains that PMS serves as the central platform for managing medicinal product information, helping reduce administrative burden, improve data governance, enhance interoperability, and support regulatory decision-making through accurate and reusable product data.

Scope of the Guidance

The guidance covers the electronic submission and maintenance of medicinal product information from the initial marketing authorisation application through the entire product lifecycle. It includes processes for initial submissions, variations, renewals, transfers of marketing authorisations, notifications, invalidations, data enrichment, and correction of existing medicinal product data.

Electronic Submission Throughout the Product Lifecycle

The guidance describes how medicinal product information should be maintained throughout its lifecycle to ensure that PMS always reflects the latest authorised information.

For newly authorised products, submission pathways differ for centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs). Centrally authorised products use SIAMED together with XEVMPD, while non-CAPs rely primarily on XEVMPD. Regardless of the authorisation route, marketing authorisation holders are responsible for keeping product information current by updating regulatory databases whenever approved changes occur.

Lifecycle activities such as variations, renewals, transfers, notifications, and marketing authorisation invalidations should all follow the appropriate electronic submission processes so that medicinal product information remains accurate across connected regulatory systems.

Enrichment and Maintenance of PMS Data

The guidance introduces the concept of data enrichment for information that was unavailable during the initial migration of medicinal product data into PMS. For eligible products, marketing authorisation holders may submit additional structured information through the PMS API or Product User Interface.

The enrichment process currently focuses on structured pack size information, manufacturers, manufacturing business operations, and selected product attributes. Once submitted, this information should be maintained whenever approved regulatory changes affect the product.

The guidance also distinguishes enrichment from data corrections. While enrichment adds missing information, corrections are used to amend inaccurate information already available in existing regulatory databases.

Supporting Digital Transformation

A key objective of the guidance is to strengthen digital transformation across the European regulatory network by promoting standardized medicinal product data. Structured information improves data quality, enables better interoperability between regulatory systems, and supports efficient reuse of medicinal product information throughout regulatory procedures.

The guidance also highlights the role of PMS in supporting the European Shortage Monitoring Platform (ESMP) by providing structured manufacturer and manufacturing information that can be used during medicine shortage monitoring and preparedness activities. In addition, future integration between PMS and electronic Product Information (ePI) will improve traceability by linking product identifiers with digital product information.

By standardizing product data, supporting lifecycle maintenance, enabling structured data enrichment, and promoting interoperability between regulatory systems, the guidance helps improve regulatory efficiency while ensuring that medicinal product information remains accurate, consistent, and up to date throughout its lifecycle.

References

• Product Management Services (PMS) – Implementation of ISO Standards for the Identification of Medicinal Products (IDMP) in Europe – Chapter 3: Process for the Electronic Submission of Medicinal Product Information.