Medicines for human use The EMA has published the document ‘eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step Guide Insert of a Development Medicinal Product (DMP) in the XEVMPD’. Rev. 1 (T1, T2, T3) Read more " February 23, 2024
Medicines for human use The EMA has released new information on the publication of PASS results (Q2, Q3). Read more " February 14, 2024
Medicines for human use The EMA has published version 1.2 of the document ‘Guidance on the electronic submission of information on investigational medicinal products for human use in the XEVMPD’ (T1, T2, T3). Read more " February 14, 2024
Medicinal products for veterinary use The EMA has published version 1.3 of the ‘Union Product Database Frequently Asked Questions’ (T1, T2, T3). Read more " February 14, 2024
Medicines for human use The EMA has released new information on the publication of PASS results (Q2, Q3). Read more " February 14, 2024
Medicines for human use The EMA has published version 1.2 of the document ‘Guidance on the electronic submission of information on investigational medicinal products for human use in the XEVMPD’ (T1, T2, T3). Read more " February 14, 2024
Medicinal products for veterinary use The EMA has published version 1.3 of the Union Product Database UPD Frequently Asked Questions T1, T2, T3. Read more " February 14, 2024
Medical devices The MDCG has published a guide on the vigilance system for CE marked medical devices: ‘ Device Specific Vigilance Guidance (DSVG) Template (T1, T2, T3). Read more " February 6, 2024
Medical devices The MDCG has published the ‘Device Specific Vigilance (DSVG) template’ (T2, T3). Read more " February 6, 2024
Medical devices The EMA has published the ‘Release notes-EVVet3 Production of January 31, 2024. (Q1, Q2, Q3). Read more " February 2, 2024
Medicinal products for veterinary use The EMA has published a version of the EU Implementation Guide Vet EU IG on veterinary medicines product data in the Union Product Database. Read more " February 1, 2024
Medicines for human use The EMA has published a new update (v. 134) of the List of European Union reference dates and frequency of submission of periodic safety update reports (T2,T3). Read more " January 31, 2024
