EMA publishes Version 2 of its Implementation Guide for the submission of data on medicinal products

Standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) are being adopted by the European Medicines Agency (EMA). An Implementation Guide (which the EMA has recently updated to version 2) has been created to help stakeholders prepare for the adoption of these ISO standards.

As part of the implementation process, the EMA has established four services relating to Substance Management (SMS), Product Management (PMS), Organisation Management (OMS) and Referential Management (RMS). Collectively, these services are referred to as SPOR in the guidance. The EMA has agreed on a phased implementation of the PMS.

Version 2 is primarily focused on supporting ‘Step 1’ of this process by preparing stakeholders for data submission via the PMS on medicinal products authorised through the centralised procedure. Once all services are fully operational, manufacturers are required to replace their current data submission format (the Extended EudraVigilance Product Report Message) with a new ISO IDMP compatible format.

The guide consists of an introduction and nine distinct chapters. The introduction outlines the content of the chapters along with which chapters haven’t changed since version 1 of the guide, which ones have been updated/newly included in version 2, and those which are scheduled for release in version 3:

  • Chapter 1 – Registration requirements: Guidance on how to get access to SPOR (updated in version 2)
  • Chapter 2 – Data elements for the electronic submission of information on medicinal products for human use: Guidance on which medicinal product information (data fields and business rules) shall be submitted (updated in version 2)
  • Chapter 3 – Process for the electronic submission of medicinal products information: Guidance on the processes driving the submission of medicinal product information (newly included in version 2)
  • Chapter 4 – Data quality assurance (scheduled for version 3)
  • Chapter 5 – Data access/export (scheduled for version 3)
  • Chapter 6 – Technical specifications: Technical specifications for the API, contains description of principles, security, resources, calls, end-points (unchanged from version 1)
  • Chapter 7 – XEVMPD – PMS Migration guide: migration rules between the extended EudraVigilance Medicinal Product Dictionary (xEVMPD) and PMS including backwards compatibility rules (unchanged from version 1)
  • Chapter 8 – Practical examples: A comprehensive list of practical examples to support the user in correctly populating the PMS data elements (newly included in version 2)
  • Chapter 9 – Process for submitting existing data on medicinal products authorised for human use (scheduled for version 3)

The EMA plans to release minor updates to version 2 (v2.1 and v2.2) throughout 2021 before the publication of version 3. Version 3 will enable relevant stakeholders to prepare for ‘Step 2’ which is the last step of product data implementation.

Click here to view the Implementation Guide in full.