Guidelines & Codes
Medsafe is in the process of progressively updating its guidelines and codes for therapeutic products. The updated guidance will be published as a single document issued as the Guideline on the Regulation of Therapeutic Products in New Zealand. The guideline will be divided into a number of topic-related parts and have two schedules, as detailed below.
Sections of the New Zealand Regulatory Guidelines for Medicines will remain relevant and available at the bottom of this page until all parts of the new guideline have been published through the links below. As each part of the new guideline is published, the text it replaces will be deleted from the “old” guidelines and a re-direction comment added to refer readers to the updated guidance. Part 10
Whenever changes to the guidance are significant, there will be prior consultation before that part of the new guideline is finalised. Editiorial and formatting changes will be progressed without consultation, although feedback will be taken into account when considering further revisions.
Guideline on the Regulation of Therapeutic Products in New Zealand
Part 1: Overview of therapeutic product regulation.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 2: Obtaining approval for new and changed medicines and related products.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 3: Regulatory requirements for medical devices.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 4: Manufacture of medicines.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 5: Labelling of medicines and related products.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 6: Bioequivalence of medicines.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 7: Advertising of therapeutic products.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 8: Pharmacovigilance.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 9: Therapeutic product safety alerts, complaints and recalls.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Part 10: Requirements for information for prescribers and consumers (Microsoft Word document 3493KB)
Part 11: Good Clinical Research Practice and obtaining approval for clinical trials.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)Schedule A: Forms and templates referred to in the Guideline.
(New content for Part 10 only. Please refer to the New Zealand Regulatory Guidelines for Medicines for further forms and templates.)Schedule B: Schedule of fees.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)
New Zealand Regulatory Guidelines for Medicines
Volume 2 - no longer published (content placed into Volume 1)
Volume 3: Interim Good Clinical Research Practice guideline
Volume 4: Consumer Medicine Information (superseded. Please refer to Guidelines on the Regulation of Therapeutic Products in New Zealand, Part 10, Section 3)
Guidelines for Advertising Medicines Direct to the Consumer
WHO Guidelines for Drug Donations
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
Interim Guidance for Industry on preparing and submitting data sheets and CMI for publication on the Medsafe website (superseded). Please refer to Guideline on the Regulation of Therapeutic Products in New Zealand, Part 10)
Medsafe’s Evaluation Policy for Priority and Abbreviated Assessments