EMA
- European Medicines Agency post-authorisation procedural advice for users of the Centralised Procedure Clean Version / Tracked Version (updated)
- European Medicines Agency Pre-authorisation guidance - Clean Version / Tracked Version (updated)
- Regulatory and procedural guideline: Validation checklist for Type II (non) clinical variations (updated)
CMDh
- UPDATE - Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations - Clean Version / Tracked Version
- UPDATE - Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure - Clean Version / Tracked Version
- UPDATE -Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure - Clean Version / Tracked Version
- UPDATE -Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure - Clean Version / Tracked Version
- UPDATE - Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure - Clean Version / Tracked Version
- UPDATE -Chapter 7: CMDh BPG on Worksharing - Clean Version / Tracked Version
- UPDATE - CMDh Best Practice Guide on the processing of renewals in the MRP/DCP - Clean Version / Tracked Version
- UPDATE - Cover letter for Variation Applications in the Mutual Recognition Procedure
- UPDATE - Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP - Clean Version / Tracked Version
- UPDATE -Applicant's response template
