EMA – Update of the Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 7
The EMA updated its EU IDMP Implementation Guide with a revised Chapter 7: Migration guide: migration rules between xEVMPD and PMS including backwards compatibility rules.
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 7:
The present chapter provides information on the approach followed by the European Medicines Agency (EMA) to enable the transformation and migration of the data to the PMS. Specifically, this chapter aims at describing the following aspects:
- migration of CAP data into PMS;
- migration of non-CAP data into PMS;
- match and merge of CAP data from SIAMED II and XEVMPD;
- the Art.57 – SIAMED II – PMS data mapping;
- the transformation rules that will be applied to the data during the migration into PMS.
More information on the Substance and product data management services on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (19 octobre 2024). EMA – Update of the Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 7. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/12ja3





