Guidelines & Codes
New Zealand Regulatory Guidelines for Medicines
Volume 1: Guidance notes for applicants for consent
to distribute new and changed medicines and related products
Note: For the Regulatory Guidelines relating to Pharmacovigilance
please refer to Section 19 of the 5th Edition below.
Note: The Regulatory Guidelines have not been updated to reflect
the new fees and forms applicable from 1 July 2009. Please see the
fees and forms pages on
the website for the most up to date information.
|
Edition 6.5
October 2009 |
Guidance notes for
applicants for consent to distribute new and changed medicines and
related products comprising Parts A to G and references |
Single PDF version (this is a large document so may take some time to
download)
(Adobe PDF document 2,356 KB) |
| Index to Parts A to G |
| Summary of Changes |
Part A - When is an application for approval
of a new or changed medicine required? Microsoft Word document
3,538 KB |
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Part B - What sort of application for approval is required?
Microsoft Word document 3,448 KB |
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Part C - Requirements for application types Microsoft Word document
3,692 KB |
Part D - Guides to preparing the content
of your application Microsoft Word document 4,158 KB |
|
Part E - Templates, declarations and checklists Microsoft Word
document 5,373 KB |
|
Part F - Medsafe’s evaluation procedures Microsoft Word document
3,590 KB |
|
Part G - Resources Microsoft Word document 3,444 KB |
| References Microsoft Word document 58
KB |
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|
|
5th Edition
(October 2001 - SUPERSEDED) |
Guidance notes for applicants for
consent to distribute new and changed medicines and related products
(October 2001)
[Note: this is a 280-page (5,620KB) Word document so may take some time to
download]
or
Online version (Windows
Help file 493KB)
[choose "Open file from its current location" on the "File Download"
screen displayed] |
| |
- Updated Guideline information for
volume 1 of NZRGM (5th edition)
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