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 |
|---|---|---|---|
| 6.6 | 3 November 2009 | Part C, Section 2.4.1 | MHRA added as a recognised authority for the abbreivated process |
| 6.5 | 22 October 2009 | Part E, Labeling 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 |