Guidelines and Codes
New Zealand Regulatory Guidelines for Medicines
Volume 1: Guidance notes for applicants for consent to distribute new and changed medicines and related products
A Summary of Changes
Table: Chronological listing of Guideline changes
| Edition | Date | Section changed | Summary |
|---|---|---|---|
| 6.15 | October 2011 | Part C | Addition of requirements for priority assessment status, minor editorial changes. Remove section on classification and redirect to “Classification” section of website |
| Parts E, F and G | Deleted as refers to superseded processes | ||
| 6.14 | July 2011 | Part C | Remove section on labelling and redirect to new Guideline on the Regulation of Therapeutic Products in New Zealand Part 5 |
| 6.1.3 | 9 March 2011 | Part A and Part D | Remove reference to Clinical Trials and redirect to new Guideline on the Regulation of Therapeutic Products in New Zealand Part 11 |
| 6.12 | 20 February 2011 | Part D, Section 4.10.2 | Information on sedating antihistamines has been added |
| Part D, Section 4.10.20 | The classification of Omeprazole has changed from Restricted to Pharmacy-only medicine when certain conditions are met. | ||
| 6.11 | 26 November 2010 | Part D, Section 4.10.4 | The wording of the Codeine section has been updated. |
| Part G, Sections 1 (Description of Dosage Form), 2 (Routes of Administration) and 3 (Shelf Life and Storage Conditions) | These sections have been updated to remove conditions/descriptions that are obsolete, not valid, or better described by another term and add in those which are in-use, but not currently stated. | ||
| 6.10 | 15 October 2010 | Part C, Section 2.4.2 | Update the Guidelines, last paragraph for this section to state that the abbreviated evaluation process may be applied to medicines approved by EMEA |
| Part C, Section 3.3 | Update the Guidelines to add Changes to Secondary Reference Standards | ||
| Part C, Section 3.4.4 | Update the Guidelines to change Updates to Plasma Master Files | ||
| Part C, Section 3.4.5 | Update the Guidelines to add Changes to Working Cell Banks or Working Seeds | ||
| Part D, Section 4.10.4 | Update the Guidelines to add information on Codeine | ||
| 6.9 | 20 August 2010 | Part D, Section 4.10.14 and 4.10.23 | Update the Guidelines to include the Recommendations from the 43rd Medicines Classification Committee Meeting |
| 6.8 | 23 April 2010 | Part D, Section 3 and Section 4.12 | Guidance removed as superseded. New guidance provided in the Guideline for Regulation of Therapeutic Products in New Zealand. |
| Part E, Section 2.2 and Section 3.5 | Forms removed as superseded. New forms provided in the Guideline for Regulation of Therapeutic Products in New Zealand. | ||
| 6.7 | 23 April 2010 | Part F, Section 1.2.1 | Information added on priority assessment of medicines manufactured in NZ for export |
| 6.6 | 3 November 2009 | Part C, Section 2.4.1 | MHRA added as a recognised authority for the abbreviated process |
| 6.5 | 22 October 2009 | Part E, Labelling Checklist for Medicines | Add part f) to the subsection 5.A |
| 6.4 | 14 August 2009 | Part C, Section 5 | Update classification and reclassification of Medicines section |
| Part D, Section 4.10 | To include conditions for Pantoprazole when sold as a restricted medicine | ||
| 5 August 2009 | Part C, Section 2.4.9-2.4.13 | Deleted - obsolete sections | |
| 6.3 | 23 April 2009 | Part A, Section 1.2 | Update about fluoride as a result of the change in fluoride classification |
| Part C, Section 2.4 | Updated guidance on the abbreviated evaluation process | ||
| Part C, Section 4.1.2 | Update about fluoride as a result of the change in fluoride classification | ||
| Part D, Section 4.10 | New labelling requirements for omeprazole and fluoride | ||
| Part D, Section 5.1 | Update about fluoride as a result of the change in fluoride classification | ||
| Part E, Section 1.7 | Updated NMA form for abbreviated process | ||
| 6.2 | 14 April 2009 | Part E, Section 1.10 | Update the fee for application for consent to distribute a new medicine (including a new combination product) containing a new active pharmaceutical ingredient |
| 6.1 | 12 March 2009 | Part D, Section 9 | New guideline on analytical procedure validation |
| Part E, Section 3.1 | Revised prescription medicine checklist | ||
| Part C, Section 2.5 | Revised guidance on the abbreviated process for granting provisional consent | ||
| 25 March 2009 | Part A, Section 1.5 | Update the name of the new ISO condom standard | |
| 6.0 | Nov 2008 | Original document |