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. Parts updated so far are:
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 (Microsoft Word document 3649KB)
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 (Microsoft Word document 3533KB)
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 3534KB)
Part 11: Good Clinical Research Practice and obtaining approval for clinical trials. (Microsoft Word document 3649KB)
New Zealand Regulatory Guidelines for Medicines
Categorisation of electronic cigarettes
Permitted Colourings for use in Medicines and Related Products
WHO Guidelines for Drug Donations
Guidelines for Standing Orders - Development and Operation
Medsafe Policy on the acceptability of claims for pain relief
Subdividing of Divided Tablets
Medsafe’s Evaluation Policy for Priority and Abbreviated Assessments