Manufacture of Medicines (Edition 5.4, November 2024) is now available. This update includes changes to recognised authorities, clarifications on GMP documentation requirements, and updates reflecting current regulatory expectations for the manufacturing of medicines in New Zealand. Key updates include adjustments to recognised authorities and requirements for evidence of Good Manufacturing Practice (GMP) compliance.
For full details, please refer to the updated document: Download the Guidelines (PDF).
Make sure to review the changes to stay compliant with Medsafe’s requirements.