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


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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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