Medsafe New Zealand Publishes Updates on Regulation of Therapeutic Products

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has issued the second version of the guideline on the regulation of therapeutic products in February 2022, and the document has been available on their website since April 2022. 

The updates are the inclusion of requirements regarding Good Manufacturing Practice (GMP) compliance for prescription medicines and the need for evidence of GMP compliance for any product regarded as a medicine in New Zealand. 

The guideline also contains the list of authorities that are recognised by Medsafe for the issuance of GMP certification. Latest information on the logos of the authorities and websites has been included. 

More details can be found in “Guideline on the Regulation of Therapeutic Products in New Zealand, Part 4: Manufacture of Medicines, 2nd revision, February 2022”:  


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