INOPP Forum

Please or Register to create posts and topics.

All about IDMP - Identification of Medicinal Products

IDMP is a suite of five standards developed within the International Organization for Standardization (ISO).  These standards provide an internationally-accepted framework to uniquely identify and describe medicinal products with consistent documentation, coding and exchange of product information between global regulators, manufacturers, suppliers and distributors.  The IDMP suite of standards is a result of a need to standardize the definition of medicinal product and substance information to facilitate the unique identification and exchange of such information in the context of pharmacovigilance.

Scope of the ISO IDMP standards

The five standards provide data elements and structures to uniquely identify and exchange information on:

  • substances (ISO 11238);

  • pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239):

  • units of measurement (ISO 11240);

  • regulated pharmaceutical product information (ISO 11616);

  • regulated medicinal product information (ISO 11615).

These standards cover the following aspects to describe a medicinal product for human use:

  • medicinal product name;

  • ingredient substances;

  • pharmaceutical product (route of administration, strength);

  • marketing authorisation;

  • clinical particulars;

  • packaging;

  • manufacturing.

ISO IDMP covers the entire medicinal product lifecycle, including products in development, investigational products, products under evaluation and authorised products.

Chapter 1 - Registration requirements

Chapter 2 - Data elements for the electronic submission of information on medicinal products for human use

 

Chapter 3 - Process for the electronic submission of medicinal product information

This chapter is scheduled for inclusion in EU IG v3.

Chapter 5 – Data access/export 

This chapter is scheduled for inclusion in EU IG v3.

Chapter 6 - Technical specifications on structure and format: Technical specifications for the API, contains description of principles, security, resources, calls, end-points 

Substances, Products, Organisations, Referentials (SPOR): SPOR API v2 Specification

 

Chapter 7 - Migration guide: migration rules between xEVMPD and PMS including backwards compatibility rules

This chapter is unchanged since EU IG v1.

Chapter 8 - Practical examples 

This chapter is newly included in EU IG v2.0. It may be subject to minor updates in v2.1 and v2.2 releases.

This chapter is scheduled for inclusion in EU IG v3.