Pre-notification check for type IB Variations
Submitted by Anonymous (not verified) on 13 July 2026 - 11:00
Pre-notification check for type IB Variations
Pre-notification check for type IA/IAIN variations
Submitted by Anonymous (not verified) on 13 July 2026 - 11:00
Pre-notification check for type IA/IAIN variations
Human medicines European public assessment report (EPAR): Lyumjev (previously Liumjev), insulin lispro, Date of authorisation: 24/03/2020, Revision: 9, Status: Authorised
Submitted by Anonymous (not verified) on 13 July 2026 - 10:33
Human medicines European public assessment report (EPAR): Lyumjev (previously Liumjev), insulin lispro, Date of authorisation: 24/03/2020, Revision: 9, Status: Authorised
Agenda - EMA/HMA European platform for regulatory science research platform meeting
Submitted by Anonymous (not verified) on 13 July 2026 - 10:20
Agenda - EMA/HMA European platform for regulatory science research platform meeting
Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1 (human)
Submitted by Anonymous (not verified) on 13 July 2026 - 10:00
Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1 (human)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 13 July 2026 - 10:00
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 13 July 2026 - 10:00
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Grouping of variations: questions and answers
Submitted by Anonymous (not verified) on 13 July 2026 - 10:00
Grouping of variations: questions and answers
Transfer of marketing authorisation: questions and answers
Submitted by Anonymous (not verified) on 13 July 2026 - 9:45
Transfer of marketing authorisation: questions and answers
Guidance on good manufacturing practice and good distribution practice: Questions and answers
Submitted by Anonymous (not verified) on 13 July 2026 - 9:41
Guidance on good manufacturing practice and good distribution practice: Questions and answers