Forms
- Section 29 Declaration/Notification Form (Microsoft Word 26KB)
- Reporting Adverse Reactions to Medicines, Vaccines and Devices and all Clinical Events for IMMP (Microsoft Word 42KB)
- Reporting Adverse Reactions to Fractionated Blood Products (Microsoft Word 45KB)
- Medical Device Incident Reporting Form (Microsoft Word 3,352KB)
- Clinical Trial Application Form (Microsoft Word 40KB)
- Changed Medicine Notification Form A (Microsoft Word 159KB) - version effective from 21 Aug 2006
- Changed Medicine Notification Form B (Microsoft Word 137KB)- version effective from 21 Aug 2006
- CMI Declaration (Microsoft Word 21KB)
- Data Sheet Declaration (Microsoft Word 20KB)
- Data Sheet Self-assessment Checklist (Microsoft Word 47KB)
- Labelling Declaration (Microsoft Word 14KB)
- Medicine Labelling Self-Assessment Checklist (Microsoft Word 37KB)
- Contact Lens Solution Labelling Self-Assessment Checklist (Microsoft Word 22KB)
- Related Product Labelling Self-Assessment Checklist (Microsoft Word 24KB)
- New Medicine Application (Microsoft Word 133KB) - version effective from 21 Aug 2006
- New Medicine Application for use with the abbreviated evaluation process (Microsoft Word 165KB) - version effective from 3 March 2008
- New Related Product Application (Microsoft Word 61KB) - version effective from 21 Aug 2006
- Changed Related Product Notification (Microsoft Word 106KB) - version effective from 21 Aug 2006
- Checklist for New Prescription Medicines Applications (CTD) (Microsoft Word 811KB) - version effective from 3 July 2007