Medicines for human use A new update on the Q&A document on how PSUSA procedure shall be implemented, has been published. T2, T3 Read more " December 10, 2025
Medicines for human use A new update on the Q&A document on non-interventional PASS including two new questions have been published. T3 Read more " December 10, 2025
Medicines for human use A new version of the document ‘List of Union reference dates and frequency of submission of PSURs’ has been published (Rev. 154) T2, T3 Read more " December 9, 2025
Medicines for human use A new version of the ICH E2D providing updates on definitions, standards and regulatory guidance for the management and reporting of post-approval drug safety information has been published, ICH E2D (R1). The document will came into force in 2026. T1, T2, T3 Read more " December 9, 2025
Medicinal products for veterinary use A new version of the document “Union Product Database (UPD) release note” (07/11/2025) has been published. T1, T2, T3 Read more " December 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. 153) T2, T3 Read more " November 6, 2025
Medicinal products for veterinary use EMA has published a new version (1.4) of the document ‘UPD-Q&A’- Industry user T1, T2, T3 Read more " November 6, 2025
Medicinal products for veterinary use EMA has published a new version (3.10) of the ‘IRIS guide for applicants’ T1, T2, T3 Read more " November 6, 2025
Medicinal products for veterinary use EMA has published a Quick guide for UPD notifications via the User interface and via email T1, T2, T3 Read more " November 6, 2025
Medicines for human use A new version of the document (Rev.5) ‘Information on the Member States requirement for the nomination of PhV contact person at national level-Human medicines has been published T1, T2, T3 Read more " November 6, 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. 152) T2, T3 Read more " October 7, 2025
Medicinal products for veterinary use A new version (23 September 2025) of the document ‘EVVet3 Production-release notes has been published. T1, T2, T3 Read more " October 7, 2025