Published: 12 April 2021

Consultations

Outcome of the consultation on the Plan to update the New Zealand Code of Good Manufacturing Practice PIC/S Guide PE009-8 to PE009-14

About the consultation

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.

Submissions received

The consultation opened on 22 February 2021 and closed on 22 March 2021.

Medsafe received six submissions on the Citizen Space platform, with one submission being blank and hence was excluded.

The submissions were made by holders of Licence to Manufacture Medicines, Licence to Pack Medicines, GMP Certificate, independent regulatory consultant, NZ sponsor, and on behalf of the membership of Medicines New Zealand.

Summary of the Consultation feedback

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.

Medsafe final decision

Medsafe would like to thank all who took the time to complete the questions and provided their comments, questions, feedback, and suggestions.

The 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 will be addressed separately and participants will be contacted (either by phone or by email) to discuss these requests.

There was one participant who commented that the implementation period of the new Code was too short, however, Medsafe’s decision is to continue the implementation in accordance with the proposed timing and target date stated in the consultation. Medsafe’s decision was based on the following:

  • Out of the five respondents, four agreed with the proposed timing for consultation and implementation and only one respondent had raised concerns. Medsafe did not receive any other feedback from stakeholders suggesting the implementation period was too short.
  • The updated PIC/S Guide PE009-14 came into effect on 1 July 2018, and in the last two years, the holders of Licence to Manufacture, Licence to Pack, and GMP certificates had been made aware of the update to the PIC/S Guide and of Medsafe’s intention to adopt the updated Code. During GMP audits in the last two to three years, companies were also encouraged to start reviewing the current NZ Code of GMP PE009-08 against the updated PIC/S Guide PE009-14 version.
  • Medsafe is allowing six months for industry to fully implement the updated Code of GMP PE009-14, from the date that the NZ Code of GMP will come into effect on 3 May 2021.
  • For the reasons mentioned above, Medsafe’s view is that affected manufacturing and packing sites have been provided sufficient time to review and implement the updated Code of GMP.

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
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