Medsafe to update the New Zealand Code of GMP PIC/S guide to the current version

Medsafe will update the New Zealand Code of Good Manufacturing Practice PIC/S Guide to the current version.

The update of the Code of GMP PIC/S Guide from version PE009-8 to PE009-14, the current version is intended to ensure alignment with global regulators and best practices as other overseas regulators (including the TGA, Australia) have adopted the current version.

Medsafe did consult with stakeholders in Q1 2021 prior to progressing with the update. An item in the consultation feedback concerns requests for additional guidance documents to interpret the GMP requirements for GMP manufacture of aseptically compounded medicines under a Licence to Manufacture and the request for further details and clarifications on other specific clauses. This item will be addressed separately and participants will be contacted to discuss these requests.

The next steps leading to the update and implementation of the New Zealand Code of GMP PIC/S Guide to the current version are as shown in the table below:

DateAction
19 April 2021Medsafe will publish the updated edition of the NZ Code of GMP on its website.
3 May 2021The updated edition of the NZ Code of GMP will come into effect.
Between 3 May 2021 to 3 November 2021New Zealand holders of a Licence to Manufacture Medicines, a Licence to Pack Medicines, or a GMP Certificate are expected to implement the updated code between these dates.
From 3 November 2021PE009-14 is expected to be fully implemented by manufacturing and packing sites from this date.

Source: Medsafe website