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. 148) T2, T3 Read more " May 8, 2025
Medicinal products for veterinary use A new version (1.9) of the chapter 7 (‘Submission of other post-authorisation data’ of the document ‘EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database’ 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
Medicinal products for veterinary use A new version (6 March 2025) of the document ‘EVVet Production-release notes. T1,T2,T3 Read more " April 11, 2025
Medicinal products for veterinary use A new version (1.8) of the ‘EU Implementation guide Vet EU IG on veterinary medicines product data in the Union Product Database’ has been published. T1,T2,T3 Read more " April 11, 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
Medicinal products for veterinary use A new version (21 March 2025) of the document ‘UPD release notes’ has been published. T1,T2,T3 Read more " April 11, 2025
Medicines for human use Template for late submission of ICSRs to EV has been published . This resource is designed to streamline and ensure consistency when submitting late ICSRs to the EV system. T1,T2,T3 Read more " April 11, 2025
Clinical trials A new version (1.2-March 2025) of the FAQs on how to submitt an annual safety report and respond to related RFIs has been published. T2,T3 Read more " April 11, 2025
Medicinal products for veterinary use A Q&A document on IRIS access and the QPPV’s role in the platform has been published T2,T3 Read more " April 11, 2025
Medicinal products for veterinary use A new version (v.2) of the document ‘CMDh Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU reference date is not yet legally binding/followed has been published’ T2,T3 Read more " March 4, 2025