Successful pilot paves the way for implementation of ePI
Submitted by Anonymous (not verified) on 16 December 2024 - 13:05
Successful pilot paves the way for implementation of ePI
Electronic product information (ePI) report: Experience gained from creation of ePI during regulatory procedures for EU human medicines
Submitted by Anonymous (not verified) on 16 December 2024 - 13:00
Electronic product information (ePI) report: Experience gained from creation of ePI during regulatory procedures for EU human medicines
Union list of critical medicines - version 2
Submitted by Anonymous (not verified) on 16 December 2024 - 11:44
Union list of critical medicines - version 2
Human medicines European public assessment report (EPAR): Vedrop, tocofersolan, Date of authorisation: 23/07/2009, Revision: 14, Status: Authorised
Submitted by Anonymous (not verified) on 16 December 2024 - 11:07
Human medicines European public assessment report (EPAR): Vedrop, tocofersolan, Date of authorisation: 23/07/2009, Revision: 14, Status: Authorised
Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors
Submitted by Anonymous (not verified) on 16 December 2024 - 10:54
Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors
Applying for orphan designation
Submitted by Anonymous (not verified) on 16 December 2024 - 10:48
Applying for orphan designation
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
Submitted by Anonymous (not verified) on 16 December 2024 - 9:57
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
Procedural advice for orphan medicinal product designation: Guidance for sponsors
Submitted by Anonymous (not verified) on 16 December 2024 - 9:48
Procedural advice for orphan medicinal product designation: Guidance for sponsors
Questions and answers on the Union list of critical medicines
Submitted by Anonymous (not verified) on 15 December 2024 - 23:42
Questions and answers on the Union list of critical medicines
Live recombinant vector vaccines for veterinary use - Scientific guideline
Submitted by Anonymous (not verified) on 13 December 2024 - 15:32
Live recombinant vector vaccines for veterinary use - Scientific guideline