Medicines for human use Se ha publicado una nueva versión (v.3.6) del capítulo 3 ‘Process for the electronic submission of medicinal product information’ del PMS-implementation of ISO standards for the IDMP in Europe’ T1, T2, T3 Read more " July 10, 2026
Medicines for human use A new version (v. 3.14) of the “IRIS Guide for Applicants” and version 2.19 of the “IRIS Guide to Registration and RPIs” have been published. T1, T2, T3 Read more " July 10, 2026
Medical devices A new version (v.8) of Chapter 1, “Registration Requirements for the Production Environment,” of the “PMS Implementation of ISO Standards for the IDMP in Europe” has been published, along with Annexes A and B, “Registration Requirements for the Test Environment” (Version 2). T1, T2, T3 Read more " July 10, 2026
Medicines for human use A new version (June 5, 2026) of the “Registration Guide for UI and API Users” has been published. T1, T2, T3 Read more " July 10, 2026
Medicines for human use A new update (Rev. 1) of the document “Questions and answers on the periodic safety update report single-assessment (PSUSA)” has been published T2, T3 Read more " June 10, 2026
Medicines for human use A new update (Rev. 4) of the document “Explanatory note to GVP Module VII” has been published T2, T3 Read more " June 10, 2026
Medicines for human use A new version (v.160) of the ‘List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)’ has been published T2, T3 Read more " June 10, 2026
Medical devices From 01/05/2026, the use of version 7.3.1 of the Manufacturer Incident Report (MIR) form is mandatory for manufacturers. T1, T2, T3 Read more " May 8, 2026
Medicines for human use The CMDh has published a new version (Rev. 8) of the document ‘CMDh Guidance on the Informal Work-Sharing Procedure for Follow-up of PSUSA for NAPs’ T2, T3 Read more " May 8, 2026
Medicines for human use A new version of the ‘List of European Union reference dates (EURD) and the frequency of submission of periodic safety update reports (PSURs)’ has been published. T2, T3 Read more " May 8, 2026
Medicines for human use A new Q&A document on the ‘Product Management Service’ has been published T1, T2, T3 Read more " May 8, 2026
