Medicines for human use An update (1.12) of the Chapter 2 of the document ‘EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database- Format for the electronic submission of veterinary medicinal product information’ has been published’ T1, T2, T3 Read more " October 6, 2025
Medicines for human use An update (16 September 2025) of the document ‘Registration guide for UI and API users’ has been published. T1, T2, T3 Read more " October 6, 2025
Medicinal products for veterinary use An update (29 August 2025) of the ‘frequently Q&A document’ on IRIS has beeb published. T2, T3 Read more " October 6, 2025
Medicinal products for veterinary use A new version (9 September 2025) of the ‘Union Product Database UPD’ release notes has been published. T1, T2, T3 Read more " October 6, 2025
Medicines for human use New HaRP assessment reports has been published along with an update of the ‘List of safety concerns’ ‘ T3 Read more " September 11, 2025
Medicines for human use EMA has published the addendum I to GVP module XVI on Risk minimisation measures for medicinal products with embryo-fetal risks. T3 Read more " September 11, 2025
Medicines for human use A new version (v. 2.4) of chapter 2 of ‘PMS-Implementation of ISO standards for the IDMP in Europe’ has been published. T1, T2, T3 Read more " September 11, 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. 151) T2, T3 Read more " August 6, 2025
Medicines for human use EMA has published a Q&A document on the webinar on SPOR and XEVMPD that took place in July 2025. T1, T2, T3 Read more " August 6, 2025
Medicines for human use A new version (3.9) of IRIS guideline for applicants have been published. T1, T2, T3 Read more " August 6, 2025
Medicines for human use Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council has been published. T1, T2, T3 Read more " August 6, 2025
Medicines for human use EMA has published a Q&A document on the signal detection section in the EV pilot phase following the publication of the revised Implementing Regulation 2025//1466. T2, T3 Read more " August 6, 2025