Post-authorisation safety studies (PASS)
Submitted by Anonymous (not verified) on 27 March 2026 - 12:40
Post-authorisation safety studies (PASS)
Type-IB variations: questions and answers
Submitted by Anonymous (not verified) on 27 March 2026 - 12:30
Type-IB variations: questions and answers
Grouping of variations: questions and answers
Submitted by Anonymous (not verified) on 27 March 2026 - 12:30
Grouping of variations: questions and answers
Worksharing: questions and answers
Submitted by Anonymous (not verified) on 27 March 2026 - 12:30
Worksharing: questions and answers
Template - Application for transfer of marketing authorisation from transferor to transferee - cover letter (human)
Submitted by Anonymous (not verified) on 27 March 2026 - 12:00
Template - Application for transfer of marketing authorisation from transferor to transferee - cover letter (human)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 27 March 2026 - 12:00
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 27 March 2026 - 12:00
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Transfer of marketing authorisation template - attachment 3
Submitted by Anonymous (not verified) on 27 March 2026 - 12:00
Transfer of marketing authorisation template - attachment 3
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 27 March 2026 - 12:00
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 27 March 2026 - 12:00
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure