The EMA updated its Products Management Services (PMS) – EU IDMP Implementation Guide with a revised Chapter 1 – Registration requirements
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
On Chapter 1:
This document has been developed with the goal of facilitating the maintenance and accessibility to data on medicinal products for human use in the EU. This document provides an overview of:
- on-boarding of users to SPOR data services;
- the registration requirements to be fulfilled in order to submit medicinal product information to PMS;
- access management to the information held in PMS;
- training requirements to submit and maintain product information in PMS.
More information on the Substance and product data management services on the EMA Website.
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vroby (8 novembre 2024). The EMA updated its Products Management Services (PMS) – EU IDMP Implementation Guide with a revised Chapter 1 – Registration requirements. ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/12nbz





