Mastering
IDMP.

IDMP stands for Identification of Medicinal Products — a set of international standards developed by the International Organization for Standardization (ISO) to support the global identification and exchange of medicinal product data.

The goal of IDMP is to ensure that medicinal products are described consistently across regulatory systems, enabling better traceability, data quality, and patient safety worldwide.

IDMP is composed of five ISO standards:

• ISO 11615 – Medicinal product
• ISO 11616 – Pharmaceutical product
• ISO 11238 – Substance
• ISO 11239 – Pharmaceutical dose forms, routes of administration, and packaging
• ISO 11240 – Units of measurement

In the EU, IDMP is being implemented through the European Medicines Agency’s SPOR data services: Substance (SMS), Product (PMS), Organisation (OMS), and Referential (RMS). These systems form the data foundation for structured regulatory submissions, including the electronic Application Form (eAF) and the upcoming European Shortages Monitoring Platform (ESMP).

SPORVIGILANCE helps you align with these standards by validating your product data against official RMS terms and PMS structure — making your data submission-ready.

IDMP is required to ensure that medicinal product information is structured, standardized, and interoperable across regulatory authorities, countries, and IT systems.

Without a global standard, the same product could be described in multiple inconsistent ways, leading to delays, errors, and safety risks. IDMP solves this by defining how products, substances, dose forms, and other key data should be represented.

In the EU, the European Medicines Agency (EMA) mandates IDMP compliance through its SPOR data services. This means companies must use approved referentials (RMS) and structured product data (PMS) when submitting applications via the electronic Application Form (eAF) or engaging with platforms like ESMP.

IDMP is not just a technical requirement — it’s a foundation for efficient regulatory operations, cross-border collaboration, and better patient outcomes.

Any organisation involved in the development, manufacturing, regulatory submission, or distribution of medicinal products in the European Union is required to comply with IDMP.

This includes pharmaceutical companies, marketing authorisation holders (MAHs), regulatory consultants, and contract manufacturing or development partners submitting information to EMA.

National Competent Authorities (NCAs) also rely on IDMP to manage product data within their jurisdiction and ensure alignment across the EU network.

IDMP compliance is particularly relevant when submitting applications via the electronic Application Form (eAF), updating product data through PMS, or interacting with EMA systems that rely on SPOR master data (RMS, OMS, SMS). As implementation expands, more touchpoints — including pharmacovigilance and ESMP — will also require IDMP-compliant data.

The ISO IDMP standards are a set of five international norms developed by ISO to support the global identification, description, and exchange of medicinal product information.

The five ISO IDMP standards are:

• ISO 11615 – Medicinal product information
• ISO 11616 – Pharmaceutical product information
• ISO 11238 – Substance data
• ISO 11239 – Controlled vocabularies for dose forms, routes, packaging
• ISO 11240 – Units of measurement

These standards form the technical foundation of EU implementation through SPOR, PMS, and eAF systems.

In the EU, IDMP is implemented by the EMA through SPOR:

• Substance Management Services (SMS)
• Product Management Services (PMS)
• Organisation Management Services (OMS)
• Referential Management Services (RMS)

These systems are the foundation for applying the ISO IDMP standards across regulatory workflows. Companies must submit structured product information using valid terms from SPOR systems.

Compliance is becoming mandatory across multiple touchpoints — especially in the electronic Application Form (eAF) and the European Shortages Monitoring Platform (ESMP).

xEVMPD is the current EU standard for submitting medicinal product data to the EMA (primarily for pharmacovigilance) and has been in use since 2012.

IDMP is a broader, global ISO standard with a hierarchical, modular structure designed for full lifecycle regulatory use cases and harmonised data exchange.

Key differences include:

• xEVMPD is flatter; IDMP is structured and modular
• xEVMPD is PV-focused; IDMP supports broader regulatory use cases
• IDMP relies on SPOR master data services; xEVMPD does not
• IDMP enables automation, reuse, and better interoperability

IDMP will ultimately replace xEVMPD as the EU transitions to the IDMP framework.

IDMP was developed by ISO in collaboration with global regulators, including the EMA, FDA, and Health Canada.

It was initiated to reduce fragmentation and ambiguity in medicinal product descriptions across countries, improving safety, data quality, and regulatory efficiency.

The first standards were published around 2011–2012, and the EMA’s SPOR services implement IDMP across the EU.

IDMP delivers regulatory, operational, and public health benefits by standardising how medicinal products are described.

• Improved data quality — fewer submission errors through standardised structures and terms
• Faster regulatory processes — increased automation and harmonised handling
• Better pharmacovigilance — easier signal detection and cross-border recall management
• Global interoperability — consistent exchange across regions and authorities
• Lifecycle alignment — traceability from development to discontinuation
• Reduced duplication — reuse across eAF, PMS, ESMP and beyond