Medsafe Guidelines - New Zealand : Pharmaceutical Guidelines

Medsafe Guidelines - New Zealand

Know about the updated Good Manufacturing Practice guidelines of Medsafe - Newzeland Government.

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 2A: Over-the-counter medicines: Pre-market application and evaluation process (Microsoft Word document 2550KB)
Part 2B: Obtaining approval for new and changed prescription 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 (Microsoft Word document 249KB)
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 1853KB)

New Zealand Regulatory Guidelines for Medicines






Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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