Medicines for human use As of 01 Apr 2024, the EMA MLM service has extended its coverage also to MEDLINE (T1, T2, T3). Read more " March 27, 2024
Medicines for human use The EMA has published a new update (v. 136) of the ‘List of European Union reference dates and frequency of submission of periodic safety update reports’ (T2,T3). Read more " March 27, 2024
Medicines for human use A new version (1.3) of the ‘Guidance on the electronic submission of information on investigational medicinal products in the XEVMPD) has been published. (T1, T2, T3). Read more " March 20, 2024
Medicinal products for veterinary use A new version of the document ‘EVVet3 Production-Releases notes’ T1, T2, T3 has been published. Read more " March 20, 2024
Medicinal products for veterinary use New ‘UPD Releases notes (15 March 2024)’ (T1, T2, T3) have been published. Read more " March 15, 2024
Other areas A new version of the document ‘New organization First User QPPV/RP or Change of EU QPPV/RP’ (13 March 2024) has been published (T1, T2, T3). Read more " March 13, 2024
Medicines for human use A new version of the EV Registration Manual (Rev. 14) has been published (T1, T2, T3). Read more " March 13, 2024
Medicines for human use A new version (13 Mar 2024) of the ‘Eudravigilance registration documents’ (T1, T2, T3) has been published. Read more " March 7, 2024
Medicines for human use New version (29 Feb 2024) of the ‘EV user declaration for qualified person for pharmacovigilance/responsible perrson of EV’, ‘Connecting to the Agency ESTRI Gateway (29 Feb 2024) and ‘EV Human Sponsor Registration form'(29 Feb 2024) (T1, T2, T3) have been published. Read more " March 7, 2024
Medicines for human use A new version ( 29 FEB 2024) of the ‘Eudravigilance support guide’ (T1, T2, T3) has been published. Read more " March 7, 2024
Medicines for human use A new version (1.7) of the ‘Eudravigilance-EVWEB User Manual’ (T1, T2, T3) has been published. Read more " March 7, 2024
Medicines for human use The EMA has published a new update (v. 135) of the ‘ List of European Union reference dates and frequency of submission of periodic safety update reports’ (T2,T3). Read more " February 28, 2024