Substance and product data management services

This content applies to human medicines only.

The Product Management Service (PMS) and Substance Management Service (SMS) will manage two of the four domains of substance, product, organisation and referentials (SPOR) master data in pharmaceutical regulatory processes. SPOR data management services will facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

The SPOR services support the implementation in the EU / EEA of the standards of the International Organisation for Standardisation (ISO) for the identification of medicinal products (IDMP).

The PMS and SMS build on the data foundations of the Referentials Management Service (RMS) and Organisations Management Service (OMS), which EMA launched in June 2017.

The PMS and SMS implementation process is iterative, in steps. The first iteration covers a subset of ISO IDMP data fields. Later iterations will see the standards fully implemented in the EU.

The first iteration of the SMS, in 2019, enabled users to request the registration of a new substance term or the update of an existing substance term through EMA Service Desk. This allows EMA to manage the substance data. Future iterations of SMS will include synchronising SMS with the European substance reference system (EU-SRS) database and delivering an SMS user interface.

The first iteration of the PMS will cover a subset of the authorised medicinal product part of the ISO IDMP standards. As part of this iteration, the new ISO IDMP compatible data submission format (HL7 FHIR) replaces the current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM).

Future PMS iterations will implement other product data elements of the authorised medicinal product and the investigational medicinal product part of the ISO IDMP standards.

For more information, see: 

• Substance, product, organisation and referential (SPOR) master data
• Data on medicines (ISO IDMP standards): Overview
• Referentials Management Service (RMS)
• Organisation Management Service (OMS)
• Extended EudraVigilance Medicinal Product Dictionary (XEVMPD): How to submit information on authorised and investigational medicines

The draft international messaging standard known as Fast Healthcare Interoperability Resources (FHIR, pronounced “fire”) was endorsed as the basis for the application programming interface (API) for PMS.

FHIR will be the data standard that supports the exchange of information about medicinal products, substances, and related referential data in the European medicines regulatory network.

EMA, the United States Food and Drug Administration (FDA) and the European medicines regulatory network are working with Health Level Seven (HL7) to incorporate the ISO IDMP standards into the FHIR specification.

For more information, see:

• Fast Healthcare Interoperability Resources
• United States Food and Drug Administration (FDA)
• Health Level Seven (HL7)

The target operating model (TOM) shows how product data can be re-used in regulatory processes and applications.

EMA is working to ensure that the technical components and business processes align with regulatory activities in order to ensure data quality and consistency across the PMS, national data systems and pharmaceutical companies’ data systems.

Infographic - PMS data process

EMA's electronic application forms (eAF) facilitate capturing data for regulatory processes. EMA is updating the electronic application forms to improve the process of entering product data. Main steps in this process:

• Pre-existing authorised product data is retrievable from the PMS database
• The relevant medicine regulatory authority assesses and manages the data submitted in the dossier (and application form). Standardised product data facilitates this process
• Product data and relevant documents are stored and made available from the PMS; once fully implemented, PMS data and documentation will fulfil the legal requirements of Article 57 of Regulation 726/2004
• Authorised product data and documents stored in the PMS can be re-used in the further regulatory activities between regulators and pharmaceutical companies

Infographic - PMS customer centricity

In 2022, EMA started replacing the PDF-based electronic applications forms with web-based forms - as part of implementing the TOM. 

This includes the variation eAF as well as forms supporting other regulatory procedures, such as the initial marketing authorisation.

The PMS is supporting implementation of the electronic forms by making ISO IDMP-compatible product data available on centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs).

It is also improving the technical components needed to reflect authorised data in the PMS.

Due to the complexity of developing and implementing a data-centric business process that is aligned with regulatory activities and the TOM technical components, EMA has to implement changes iteratively, in several steps. As a result, transition periods when multiple systems are being used in parallel are unavoidable, even though this is inconvenient for regulators and applicants.

EMA is in the process of updating the three-year portfolio objectives as input for the portfolio roadmap. This includes the prioritisation of the ISO IDMP implementation roadmap, including replacing the Article 57 data submission format. EMA is carrying out these activities following an agile approach. It is working closely with industry stakeholders and its partners in the European medicines regulatory network to align strategic priorities and ensure that the portfolio reflects the needs of all stakeholders. 

In 2022, EMA expected to progress the following activities:

• Make ISO IDMP-compatible product data available on all authorised medicinal products in the EU, including both centrally authorised products and non-centrally authorised products. This will result from a data migration and continuous updates from the EMA database (SIAMED) and the xEVMPD (Article 57) database to the PMS following the ISO IDMP standards;
• Enable pharmaceutical companies to correct and complete PMS product data;
• Enable data approved within a regulatory application to be stored in the PMS;
• Ensure adequate data quality in the PMS so that it can be confidently reused across procedures.  

Marketing authorisation holders must continue to submit data on authorised medicines in the XEVPRM format in order to comply with their regulatory obligations under Article 57 of Regulation 726/2004.

For more information, see:

• Data submission on authorised medicines (Article 57)

Marketing authorisation holders and national competent authorities should:

• align their systems with the released terminologies for referentials, organisation and substance data;
• request the registration of any new or missing controlled vocabulary  required for the submission of medicinal product data;
• start  structuring their product data according to the rules described in chapter 2 of the EU IG.

EMA and the European medicines regulatory network have agreed on a phased PMS implementation.

Select the expandable panels below for more information on the different implementation phases.

A roadmap is available below providing a visual overview of the PMS implementation. 

Mandatory submission of medicine data

Information helping marketing authorisation holders and national competent authorities to map their products in EMA's product management service (PMS) is available to registered users with full access to the Product Lifecycle Management portal (PLM):

• Product Lifecycle Management Portal

This helps them report data on the supply and demand of medicines to the European Shortages Monitoring Platform. It is part of their mandatory reporting requirementsand is meant to help prevent, detect and manage human medicine shortages.   

Guidance on how to access the dynamic product reports that contain this information is also available on the PLM portal: 

• PLM - PMS Product UI Navigation Guidance

In February 2025, the dynamic product reports replaced the list of products and pack sizes that EMA previously made available. This document was based on the first version of the Union list of critical medicines. The document is outdated but remains available below for information.

The EU IDMP Implementation Guide (EU IG) for the submission of data on medicinal products defines the implementation requirements of the ISO IDMPstandards for the EU. The EU IG is the basis for submitting and exchanging medicinal product data in the EU. 

Its purpose is to enable stakeholders to prepare for the implementation of ISO IDMP standards in EU.

It provides information on the following: 

• Timelines
• Requirements
• Process
• Technical specification
• Data elements
• Associated business rules

EMA last updated EU IDMP Implementation Guide (EU IG) in January 2023.

Click on the guidance update history below to find out more about the changes introduced by this and previous updates.

Applicants can start applying the rules in the latest update to structure their product data. This enables them to complete and correct any product data as necessary before the use of the electronic application forms becomes mandatory at the end of a transition period.

During 2023, EMA will release further updates to the guide. 

The EU IG is composed of the chapters below. 

This chapter is scheduled for inclusion in subsequent releases of the EU IG. 

This chapter is unchanged since the first release of EU IG.

As of January 2023, EMA hosts and maintains the EU Substance Registration System (EU-SRS) that gathers scientifically sound data on substances used in medicines. 

These data include defining characteristics of substances, molecular structures, and amino acid sequences and relationships.

The EU-SRS covers a variety of use cases, such as:

• providing insight on the characteristics of a substance;
• supporting assessors in the areas of quality, safety and pharmacovigilance;
• helping introduce a structured data approach for regulatory submissions. 

The Substances Validation Group maintains the actual substance data. This group brings together experts from national competent authorities in EU countries. 

The German Federal Institute for Drugs and Medical Devices (BfArM) previously maintained the EU-SRS.

For more informatin, see: 

• German Federal Institute for Drugs and Medical Devices (BfArM)