EMA Guidance: Electronic Submission of Medicinal Product Data under IDMP (Chapter 3 Explained)

The European Medicines Agency (EMA) continues to advance data standardisation and digital transformation in regulatory processes through the implementation of ISO IDMP standards and Product Management Services (PMS).

The guidance Process for the electronic submission of medicinal product information – Chapter 3 (Version 3.5, updated 20 April 2026) provides detailed instructions on how medicinal product data should be submitted, managed, and maintained electronically throughout the product lifecycle.

ISO IDMP standards establish harmonised definitions and structured formats for medicinal product data across the EU. Their implementation is legally required under EU regulations governing pharmacovigilance and data exchange.

This guidance outlines the process for the electronic submission of medicinal product information in the European Economic Area (EEA) using ISO IDMP standards. It covers the full lifecycle of a medicinal product, from initial marketing authorisation submission to post-authorisation maintenance activities.

The use of structured data formats ensures consistent identification, interoperability, and efficient data exchange between regulators and marketing authorisation holders (MAHs).

The guidance applies to marketing authorisation holders (MAHs), regulators, and stakeholders involved in submitting and maintaining medicinal product data.

It includes:

• Initial product data submission

• Lifecycle maintenance activities

• Data correction and enrichment processes

• Integration across regulatory systems

Target Operating Model (TOM)

The Target Operating Model represents the future state of data submission and management, aiming to integrate regulatory processes with structured data submission.

It focuses on:

• Improving data quality and governance

• Enhancing interoperability and reusability

• Reducing administrative burden

• Supporting digital transformation across the EU regulatory network

The TOM ensures that data submission becomes an integrated part of regulatory decision-making processes rather than a separate activity.

Current Operating Model

The current system defines how medicinal product data is managed across its lifecycle.

It includes key processes such as:

• Initial submission of authorised products

• Variations

• Renewals

• Transfers of marketing authorisations

• Notifications

• Data enrichment and corrections

The diagram on page 6 of the guidance illustrates how data flows between systems such as eAF, XEVMPD, SIAMED, PMS API, and PLM Portal, showing the interconnected regulatory ecosystem.

Initial Submission of Medicinal Products

For initial marketing authorisation applications:

• A PDF electronic Application Form (eAF) must be submitted

• Data is processed differently for:

  • Centrally Authorised Products (CAPs) → Data flows via SIAMED and PMS

  • Non-Centrally Authorised Products (non-CAPs) → Data flows via XEVMPD

MAHs must submit product data to XEVMPD within 15 days of approval, ensuring alignment with regulatory requirements.

Maintenance of Medicinal Product Data

After authorisation, product data must be continuously updated throughout its lifecycle.

Variations

Changes to product information must be submitted using the web-based eAF, and updates are reflected in PMS via SIAMED or XEVMPD, depending on product type.

Renewals

Renewals are submitted using the PDF eAF, with updates subsequently reflected in PMS systems.

Transfers of Marketing Authorisation

When ownership changes, both previous and new MAHs must follow defined processes to ensure correct data transfer and continuity in PMS.

Invalidation of Authorisations

Revoked or withdrawn authorisations must be updated to reflect accurate product status in PMS.

Notifications

Certain updates, such as pharmacovigilance details (QPPV, PSMF), are submitted directly through XEVMPD and automatically reflected in PMS.

Reference

For more information and details on other topics, such as Data Enrichment, Correction of Data, etc refer to the complete guidance:

Process for the electronic submission of medicinal product information – EMA (Chapter 3)

Also check out his guidance on Chapter-9 Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas - Chapter 9