On 22 February 2021 Medsafe sought feedback on the Plan to update the New Zealand Code of Good Manufacturing Practice from the PIC/S Guide PE009-8 version to the PE009-14 version.
The update to the Code was intended to ensure alignment with global regulators and best practices as other overseas regulators (including the TGA Australia) have adopted the most recent PIC/S Guide to GMP version PE009-14.
This consultation included questions for stakeholders to respond to, using the Ministry of Health’s online consultation tool, Citizen Space.
The consultation opened on 22 February 2021 and closed on 22 March 2021.
Overall, the feedback from the five respondents was generally positive and four supported the proposed timing for consultation and implementation of the Code. There was a request for additional guidance documents to interpret the GMP requirements for GMP manufacture of aseptically compounded medicines under a Licensed to Manufacture. There were requests for further details and clarifications on some specific clauses which affect individual responders. One participant raised concern over the proposed timing for consultation and implementation of the new Code.
Next step
- Medsafe will publish the updated edition of the NZ Code of GMP on Medsafe website on 19 April 2021
- The updated edition of the NZ Code of GMP to come into effect on 3 May 2021
- New 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 3 May 2021 to 3 November 2021
- Medsafe will use the updated NZ Code of GMP as the terms of reference for GMP audits from 3 May 2021.
- PE009-14 is expected to be fully implemented by manufacturing and packing sites from 3 November 2021
