Medicines for human use A new version (Rev. 3) of the document ‘CMDh Standard Operating Procedure on the Processing of PSUR Single Assessment Procedures for Nationally Authorised Products’ updating the criteria for the selection of a PSUSA LMS, has been published. T2, T3 Read more " July 9, 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. 150) – T2, T3 Read more " July 9, 2025
Medicines for human use EMA has published a new version (3) of chapter 9 of the document ‘PMS implementation of ISO standards for the IDMP in Europe’-Process for submitting exisiting data on medicinal products authorised for human use-SIAMED II & XEVMPD to PMS deltas. T1, T2, T3 Read more " July 9, 2025
Medicines for human use EMA has published a new version (V. 3) of the document ‘On-boarding of users to SPOR data services’ T1, T2, T3 Read more " July 9, 2025
Medicinal products for veterinary use EMA has published a new version of the (Rev 1.7.2523) of the document ‘Union Produc Database (UPD) release notes’ T1, T2, T3 Read more " July 9, 2025
Medicines for human use EMA has published a new version of the (Rev 7.1) of the document ‘QC of medicinal product data submitted as per the legal requirement introduced by Article 57(2) T1, T2, T3 Read more " July 9, 2025
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
