Medicines for human use A document on FAQs on Product Management Service (PMS) has been published (v. 2 June 2025). T1, T2, T3 Read more " July 9, 2025
Medicines for human use A new version of chapter 3 of the document ‘Process for the electronic submission of medicinal product information’ T1, T2, T3 Read more " July 9, 2025
Medical devices The new Manufacturer incident report (7.3.1) for medical devices has been published. T1, T2, T3 Read more " June 4, 2025
Medicinal products for veterinary use A new version of the document ‘List of Union reference dates and frequency of submission of PSURs’ has been published (Rev. 149) T2, T3 Read more " June 4, 2025
Medicines for human use EMA has published a new versión (Rev.16) of the document ‘EMA Eudravigilance Registration Manual’ T1, T2, T3 Read more " June 4, 2025
Medicines for human use EMA has published a new versión (1.10) of document ‘EVWEB User Manual’ T1, T2, T3 Read more " June 4, 2025
Medicinal products for veterinary use EMA has published a new version (1.11) of chapter 2 ‘Format for the electronic submission of veterinary medicinal product information’ of the ‘Vet EU IG’ T1, T2, T3 Read more " June 3, 2025
Medicinal products for veterinary use EMA has published a new version (3.0) of the Data Warehouse user manual for EVVET T1, T2, T3 Read more " June 3, 2025
Medicinal products for veterinary use EMA has published a Registration guide for UI and API users of the Union Product Database. T1, T2, T3 Read more " June 3, 2025
Medicines for human use EMA has published a new revision (2.3) of the chapter 2 of the PMS-Implementation of ISO standars for IDMP in Europe T1, T2, T3 Read more " June 3, 2025
Medicines for human use EMA has published a new revision (rev.5) of the document ‘EMA policy on access to EV data for medicinal products for human use). T1, T2, T3 Read more " June 3, 2025
Medicines for human use EMA has issue clarifications on what consitutes “significant non-compliance” when it comes to notifying EMA and relevant NCAs these situations including what types of ICSR notification delays are considered significant T1, T2, T3 Read more " May 8, 2025