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
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
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
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
Medicines for human use A new version (Rev.3) of the document ‘Anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans-body an annexes 4 and 6’ T3 Read more " May 8, 2025
Medicines for human use A new version (March 2025) of the section Q&A on PSURs has been published. T2,T3 Read more " April 11, 2025
Medicines for human use A new version (March 2025) of the section Q&A on PASS has been published. T2,T3 Read more " April 11, 2025
