REGULATORY INFORMATION

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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 6.15 November 2011	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 2,276 KB)
	Index to Parts A to D
	Summary of Changes
	Part A - When is an application for approval of a new or changed medicine required? Microsoft Word document 3,554 KB
	Part B - What sort of application for approval is required? Microsoft Word document 3,458 KB
	Part C - Requirements for application types Microsoft Word document 3,699 KB
	Part D - Guides to preparing the content of your application Microsoft Word document 4,145 KB
	References Microsoft Word document 59 KB
5th Edition (October 2001 - SUPERSEDED)	Guidance notes for applicants for consent to distribute new and changed medicines and related products (October 2001) [Note: this is a 280-page (5,620KB) Word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) Introducing an extended abbreviated evaluation process (effective from 3 March 2008) Revised Schedule of Fees - effective from 3 March 2008 (Mar 2008) Biostudy Reference Products (Jul 2006) Guidance for Over-the-Counter Pregnancy Test Kits (Oct 2003) Products Containing Paracetamol - Revised Guideline (May 2002) Update to Section 5.7 Processing times for Applications and Notifications (Jul 2006) Section 6.3 CTD Formatted Dossiers Explanatory Note on Section 6.6 Submitting an Application for Notification (Oct 2006) Explanatory Note on Section 6.10 Proprietary Names Update to Section 8.3: Standard requirements for new multi-source (generic) prescription medicines Update to Section 10.1B: New and changed related products - dentifrices Amendments to Section 12: Sample/starter packs and labelling of multivitamin preparations Deadline for Labelling of Non-Sedating Antihistamines (Section 12.10.2) Update to Section 12.10.6: Corticosteroids as aqueous solutions for nasal inhalation Update to Section 12.10.10 H2 Antagonists Update to Section 12.10.11: Ibuprofen Update to Section 13.2.2:  Preparing a data Sheet for approval - Content (Nov 2007) Update to Section 13.2.2: Preparing a datasheet for approval - content (Sept 2003) Correction to Section 13.6.2: Non-steroidal anti-inflammatory agents Appendix 1:  Schedule of Fees - effective from 21 August 2006 Appendix 2:  NMA Form - effective from 21 August 2006 Appendix 2a:  NMA Form for abbreviated evaluation process  - effective from 3 March 2008 Appendix 3:  NRPA Form - effective from 21 August 2006 Appendix 5:  CMN Form A - effective from 21 August 2006 Appendix 6:  CMN Form B - effective from 21 August 2006 Appendix 7:  CRPN Form - effective from 21 August 2006