NZ: Recognition of ISO/IEC 17025:2017 accreditation as appropriate for laboratories testing medicinal cannabis products and starting material for export

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The Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (the Regulations) set the minimum quality standard that medicinal cannabis products and cannabis-based ingredients must meet before they can be supplied in New Zealand. Importers, manufacturers, and suppliers must apply for assessment and provide evidence to the Medicinal Cannabis Agency (the Agency) to verify that their products meet the minimum quality standard.

The Agency has recognised ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories accreditation (ISO/IEC 17025:2017 accreditation) as appropriate for laboratories conducting certain tests required by the Regulations. This is in addition to the recognition of certification to the requirements of the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (GMP-certified) for testing facilities.

Medicinal cannabis products and cannabis-based ingredients are still required to be manufactured by a GMP-certified manufacturer.

ISO/IEC 17025:2017 accreditation has been recognised as appropriate for laboratories testing starting material for export.

ISO/IEC 17025:2017 accreditation has also been recognised as appropriate for laboratories testing cannabis-based ingredients and medicinal cannabis products for tests not considered critical.

Tests that measure variables considered critical must still be performed by a GMP-certified laboratory or manufacturer (see Table 1).

Table 1. GMP and ISO/IEC appropriate tests

Tests not considered critical do not require evidence of method validation to be submitted to the Agency if the testing laboratory uses the applicable European Pharmacopeia method, except in the case of identification for active ingredients. For the identification test for active ingredients performed by an ISO/IEC 17025:2017 accredited laboratory, the Medicinal Cannabis Agency will require method validation in line with ICH Q2 (R1) guidance.

Certification will only be accepted for accredited domestic and international laboratories who are signatories of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement.

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