REGULATORY INFORMATION

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Guidelines & Codes

• New Zealand Regulatory Guidelines for Medicines: volumes 1- 4 (see below for updates to volume 1)
• New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods
• Guidelines for Advertising Medicines Direct to the Consumer
• Safe Management of Medicines - A Guide for Managers of Old People's Homes and Residential Care Facilities
• WHO Guidelines for Drug Donations
• Medical Device Standards
• Polyurethane Condom Standard
  
   
• Updated Guideline information for volume 1 of NZRGM (5th edition)
  • Abbreviated process for granting Provisional Consent under Section 23 of the Medicines Act 1981 to certain medicines currently supplied under Section 29 of the Act (effective from 17 March 2008)
  • 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 4:  Checklist for New Prescription Medicines Applications (CTD) - effective from - effective from 17 August 2007
  • 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
    
     
• Guidelines for Standing Orders - Development and Operation
• Medsafe Policy on the acceptability of claims for pain relief
• Updated Dosing Guidelines for Divided Tablets
• Ephedrine and Pseudoephedrine to become Controlled Drugs from 15 October 2004
• Clarification of the Classification for Sedating Antihistamines
• Guideline for the transfer of analytical test procedures - 10 August 2007