New Zealand's GMP requirements — Medsafe's near-verbatim PIC/S PE009-14 adoption under the Medicines Act 1981, distinct from but structurally near-identical to Australia's TGA adoption of the same guide.

New Zealand GMP — Medsafe / New Zealand Code of GMP Audit-Readiness Rubric — Regscribe v0

(Medicines Act 1981 / Medicines Regulations 1984, as administered by Medsafe — adopting the PIC/S Guide to GMP, PE009, as the New Zealand Code of GMP)

Scope boundary and headline finding — read this before scoring anything. New Zealand does not have its own home-grown GMP text. Medsafe (the New Zealand Medicines and Medical Devices Safety Authority, part of the Ministry of Health) adopts the PIC/S Guide to Good Manufacturing Practice (PE009) essentially verbatim as "the New Zealand Code of GMP," under the legal authority of the Medicines Act 1981 and Medicines Regulations 1984. New Zealand has been a full PIC/S member since 2012. This means:

The overwhelming majority of the substantive manufacturing-quality content in this rubric is identical, clause-for-clause, to Australia's TGA adoption of the same PIC/S PE009 guide (see this project's companion docs/au-gmp-rubric.md) and closely related to the PIC/S-derived chapters already modeled in docs/gmp-gdp-rubric.md (EU GMP Vol. 4, Part I) and docs/jp-gmp-rubric.md (Japan's PIC/S-referencing GMP Ordinance). This document does not re-derive that shared PIC/S substance from scratch — instead it cites the PE009 chapter/annex structure directly, cross-references the equivalent EU-GMP rows already built out in gmp-gdp-rubric.md (which covers the same underlying PIC/S-descended Chapter 1/4/5/6/7 text and Annexes 11/15 in clause-level depth), and concentrates its own rows on what is genuinely New Zealand/Medsafe-specific: which PE009 version and which annexes NZ has actually adopted (a materially different subset and vintage than either the EU's current text or the Australia rubric may show), the Medicines Act/Regulations licensing-and-enforcement layer, the New Zealand-specific "GMP Certificate" instrument for contract testing laboratories, and the New Zealand Medicines and Medical Devices Recall Code (Part V of the NZ Code).
Honest assessment up front: if a Regscribe customer's document set is already being scored against EU GMP (Chapters 1–9) or Australia's PIC/S adoption, the marginal substantive GMP content unique to a Medsafe rubric is genuinely thin. The value of this document is almost entirely in the administrative/legal layer (NZ licensing regime, which PE009 version/annexes actually apply in NZ right now, and Medsafe-specific instruments) rather than in a differently-worded manufacturing-quality standard. This is stated plainly rather than padded with false distinctiveness.
NZ and Australia are separate regulators, not a combined agency. Despite a long-standing NZ–Australia Mutual Recognition Agreement (trans-Tasman goods recognition) and a joint "Australia New Zealand Therapeutic Products Authority" (ANZTPA) scheme that was proposed repeatedly (originally as "ANZTPA" from the mid-2000s, revived and again shelved) and never implemented, Medsafe and the TGA remain legally distinct regulators operating under different national statutes (Medicines Act 1981/Medicines Regulations 1984 for NZ; Therapeutic Goods Act 1989 for Australia). A document compliant with TGA's manufacturing-licence regime is not automatically compliant with Medsafe's — the underlying PIC/S GMP substance may be near-identical, but the licensing instrument, the specific PE009 version/annex subset currently in force, and the enforcement mechanism are each jurisdiction-specific and must be checked as such.

Sources used

Regulatory/administrative structure (primary-ish — official Medsafe pages, fetched directly):

Medsafe, "Introduction to the New Zealand Code of GMP for Manufacture and Distribution of Therapeutic Goods" — medsafe.govt.nz/regulatory/guideline/nzgmpcodepart1intro.asp — confirms the Code is used "to determine whether applicants for Licences to Pack Medicines or Licences to Manufacture Medicines meet appropriate standards of GMP to enable licences to be issued pursuant to the Medicines Act 1981 and Medicines Regulations 1984," and that the Code is also used to assess applicants for GMP Certificates (a distinct instrument, for contract testing laboratories — see below).
Medsafe, "New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods" (index page) — medsafe.govt.nz/regulatory/guideline/NZRGMPart1.asp — confirms the Code's five-document structure: an NZ-specific introductory guide, Part I (medicinal products, effective 3 May 2021, implementing PIC/S PE009-14), Part II (active pharmaceutical ingredients), and the PE009-14 Annexes 1, 2, 6–11, 13–15, 17, 19 and 20 (i.e., a subset — see exclusions below).
Medsafe, "Plan to update the New Zealand Code of Good Manufacturing Practice" consultation page (medsafe.govt.nz/consultations/Update-NZ-Code-GMP.asp) and the parallel MOH Citizen Space consultation record (consult.health.govt.nz/medsafe/update-the-nz-code-of-gmp/) — both independently confirm: consultation ran 22 Feb–22 Mar 2021; the updated Code (moving from the prior PE009-8 version to PE009-14, effective 1 July 2018 in PIC/S's own numbering) was published 19 Apr 2021 and took effect 3 May 2021; non-compliances against the new requirements were not treated as deficiencies until 3 November 2021 (a 6-month grace/implementation period). Cross-checked consistently across three independent Medsafe/MOH pages — treated as high-confidence.
Medsafe, "Review of Code for GMP" consultation page (medsafe.govt.nz/consultations/Update-NZ-Code-GMP-Review-of-Code.asp) — the only place a substantive NZ-specific technical reasoning was found: for Annex 14 (Blood/Plasma Products, one of the included annexes), the review states "New Zealand does not have any plasma fractionation facilities, hence much of the new Annex 14 specific to plasma fractionation does not apply" — direct evidence Medsafe tailors PIC/S text to NZ's actual manufacturing base rather than applying it as inert boilerplate.
Excluded annexes: Annexes 3, 4, 5, 12, 16, and 18 are excluded from the New Zealand Code, per a WebSearch-summarized secondary characterization of the Medsafe Code index that was independently cross-checked against the NZRGMPart1.asp fetch's own list of included annexes (1, 2, 6–11, 13–15, 17, 19, 20) — the two lists are mutually consistent (together they cover the full PIC/S 1–20 Annex set, with no gaps or overlaps), which gives reasonable confidence in the exclusion list even though no single Medsafe page was found stating the excluded list in so many words. No Medsafe-published reasoning was found for the exclusion of Annexes 3, 4, 5, 12, 16, or 18 specifically (unlike the Annex 14 example above) — this rubric's explanation of why each is plausibly excluded (below) is regulatory-structure inference, not a quoted Medsafe justification, and is flagged as such.
Medicines Regulations 1984 (SR 1984/143) — structure confirmed via legislation.govt.nz search-result snippets and NZLII: regulation 45 ("Application for licence to manufacture, hawk, sell, or pack medicine" — Form 1, Schedule 2) and regulation 46 ("Form and conditions of licence" — Form 2, Schedule 2) sit within Part 8 (Licences) of the Regulations. Direct WebFetch of legislation.govt.nz was blocked with HTTP 403 on every attempt this session (a known bot-blocking pattern also documented in this project's other US/eCFR-sourcing rubrics) — the regulation numbers and titles above are sourced from Google-indexed page titles/snippets of the legislation.govt.nz pages themselves (i.e., the site's own metadata, surfaced via search, not independently re-fetched and read in full) plus a WIPO Lex-hosted historical reprint that also 404'd on direct fetch. Full clause-level text of regs 45–46 was not independently read this session — treat the regulation numbers/titles as reliable (multiple consistent search-result citations) but the substantive wording as unverified.
Medicines Act 1981 — section structure confirmed the same way (search-result snippets, not full-text fetch, for the same 403-blocking reason): section 17 ("Manufacturers, wholesalers, packers of medicines, and operators of pharmacies to be licensed"), section 37 ("Powers of Minister to prohibit import, etc., of medicines" — confirmed via two real 2020/2021 NZ Gazette notices issued under this section, gazette.govt.nz/notice/id/2020-go1737 and gazette.govt.nz/notice/id/2021-go1533, titles only), and section 52 ("Effect of licences"). Full clause text not independently fetched this session — same 403-blocking caveat as the Regulations above.
Medsafe, "Guideline on the Regulation of Therapeutic Products in New Zealand" — Overview and Manufacture-of-Medicines PDFs (medsafe.govt.nz/regulatory/Guideline/GRTPNZ/) — fetched; confirmed the Medicines Act 1981/Medicines Regulations 1984 legal basis, Medsafe's role, and general PIC/S alignment, but the specific PDF text on licensing procedure, fees, and timelines was not cleanly extractable this session (return was a high-level paraphrase, not verbatim clause text) — flagged as a secondary-tier confirmation only, not a primary-text read.
NZ Medicines and Medical Devices Recall Code, September 2015 (medsafe.govt.nz/safety/RecallCode.pdf) — confirmed via WebSearch snippets (not independently fetched/read in full this session) that recalls must be conducted "with Medsafe's knowledge and consent," per GMP Part V of the NZ Code, with a public Medsafe Online Recalls Database live since 1 July 2012. Not independently fetched and read this session — section-by-section Recall Code detail below is at summary level only, sourced from search-result text, and should be verified against the primary PDF before production use.
Wikipedia, "Medsafe" — used only for basic organizational facts (est. 1998, ~60 staff, Wellington + Auckland offices) — explicitly flagged by the article itself as incomplete ("needs expansion"), and contains no enforcement/recall/controversy content of any kind — see Gaps below on the resulting enforcement-evidence hole.

Enforcement / failure-pattern data:

No named, verifiable Medsafe GMP-noncompliance enforcement action, manufacturing-licence suspension/revocation, or GMP-attributed product recall was found this session, despite multiple targeted WebSearch attempts (general enforcement terms, "licence suspended/revoked," "recall GMP failure," Wikipedia controversies section). This is a materially larger enforcement-evidence gap than every other rubric in this project — the EU/Japan/US rubrics all found at least one real, citable case (MHRA deficiency-trend data, Kobayashi Kako, IBT/Craven Labs, respectively). No equivalent was located for Medsafe. This may reflect genuine rarity (New Zealand's licensed-manufacturer base is small — a handful of licensed sites plus imported product from PIC/S-recognized overseas manufacturers) rather than a search failure, but that cannot be confirmed either way this session. Every failure-pattern cell below is therefore marked [ANALOGOUS] (borrowed from the EU/PIC/S-sourced companion rubrics' real enforcement data, since the underlying clause text is the same PIC/S language) or [REPRESENTATIVE] (a structural/textbook inference), never [REPRESENTATIVE — NZ-specific] or an NZ-named case, because no such case was found.
The Medsafe Online Recalls Database (medsafe.govt.nz/hot/recalls/recallsearch.asp) is confirmed to exist and to be the correct primary source for real NZ recall case mining, but was not queried/searched this session (a search-interface database, not a static page WebFetch could usefully paginate) — flagged as the single highest-value follow-up for a future session (see Gaps).

Rubric legend

Each row: Requirement (plain language) → Citation → Evidence that demonstrates compliance → Common failure pattern

Failure-pattern cells are marked:

[ANALOGOUS] — the underlying requirement is the same PIC/S PE009 (or closely-descended EU GMP Vol. 4) clause already documented with real enforcement data in this project's gmp-gdp-rubric.md (MHRA deficiency data) or jp-gmp-rubric.md companion rubrics; the failure pattern is borrowed from that real data because no independent Medsafe-specific enforcement example was found this session. Always states which companion rubric/example it borrows from.
[REPRESENTATIVE] — a well-established, textbook-level GMP failure mode inferred from the clause's own structure/purpose, not tied to any specific named enforcement action (Medsafe or otherwise).
[UNVERIFIED — flagged, not used] — a claim that could not be independently verified this session and is not relied upon in any row below.
No [HISTORICAL] marker is used — no founding-scandal origin story for the New Zealand Code of GMP was found or is claimed; the Code's history is one of iterative PIC/S-version adoption (see Sources), not a single crisis-driven original enactment the way US GLP or Japan's GQP/GVP split can be traced to a specific scandal.

PART A — Legal and licensing framework (New Zealand-specific)

#	Requirement	Citation	Evidence	Common failure pattern
1	Licensing requirement: no person may manufacture, wholesale, pack, or (for pharmacies) operate without a licence issued under the Medicines Act 1981; a Licence to Manufacture Medicines authorises manufacture, packing/labelling, and wholesale sale of the medicines described in the licence, confined to the premises specified in it.	Medicines Act 1981, s 17 ("Manufacturers, wholesalers, packers of medicines... to be licensed"); s 52 ("Effect of licences")	Current Licence to Manufacture Medicines or Licence to Pack Medicines, naming the specific site and product scope; confirm the document under analysis concerns activity actually covered by the named licence's premises/product scope	[REPRESENTATIVE] A manufacturing or packing activity conducted at a site, or for a product class, not named on the current licence is a bright-line, high-severity scope gap — structurally the same "operating outside the terms of the authorisation" finding that underlies manufacturing-authorisation-scope checks in every PIC/S-descended framework in this project (EU GMP "manufacturing authorisation," TGA licence, Japan's manufacturing-manager-scoped licence).
2	Application for licence: an application for a Licence to Manufacture, Pack, Hawk, or Sell medicine must be made in the prescribed form (Form 1, Schedule 2); the resulting licence, if granted, is issued in the prescribed form (Form 2, Schedule 2) and is subject to whatever conditions are attached.	Medicines Regulations 1984 (SR 1984/143), reg 45 (application), reg 46 (form and conditions of licence), Part 8	The granted licence document itself, including any attached conditions (e.g., product-specific restrictions, named responsible personnel)	[REPRESENTATIVE] A licence-conditions schedule that has not been updated to reflect a subsequent change in the site's actual product range or responsible-person appointments is the NZ-specific version of the "authorisation not kept current with actual operations" gap.
3	GMP Certificates for contract testing laboratories — a distinct instrument from the manufacture/pack licences: Medsafe separately assesses and certifies contract testing laboratories against the NZ Code of GMP, issuing a GMP Certificate rather than a manufacturing/packing licence, since a testing-only laboratory does not manufacture or pack product.	Medsafe, "Introduction to the NZ Code of GMP" page (nzgmpcodepart1intro.asp); Medsafe's published list of GMP Certified Contract Testing Laboratories (medsafe.govt.nz/regulatory/contractTesting.asp — page located via search, not independently fetched/read this session)	Current GMP Certificate naming the specific laboratory and test methods/scope in-certificate; confirm any outsourced-testing arrangement in a document under analysis names a laboratory actually appearing on Medsafe's published certified-laboratory list	[REPRESENTATIVE] This is a genuinely NZ-specific administrative distinction Regscribe should model as its own evidence type (`nz_gmp_certificate`, distinct from `manufacturing_licence`) — a document that treats a contract testing lab's GMP status as covered by the sponsor's own manufacturing licence, rather than checking the lab's own separate GMP Certificate, is a category error specific to how NZ (unlike, e.g., the EU's single-authorisation model) splits these two instruments.
4	Ministerial prohibition power: the Minister of Health may, by notice, prohibit the import, manufacture, packing, sale, possession, supply, administration, or other use of specified medicines or medical devices; contravening such a notice is itself an offence. This is a distinct, higher-severity enforcement lever than ordinary licence conditions — confirmed as actively used via two real Gazette notices (2020, 2021).	Medicines Act 1981, s 37	N/A for routine document scoring — this is a regulator-side enforcement mechanism, not a manufacturer document type; relevant to Regscribe only as a "check whether the product/manufacturer appears under an active s 37 notice" pre-screening gate, structurally analogous to the FDA-disqualified-facility pre-screening gate documented in `cfr58-glp-rubric.md`	[REPRESENTATIVE] Confirmed real-world instrument (two Gazette notices found, titles only, content not read this session) — treat as a live enforcement mechanism, not a dormant statutory power, but do not over-claim specifics not verified this session.
5	Overseas manufacturing sites / imported product: as a PIC/S member, Medsafe participates in PIC/S's mutual-reliance framework for GMP inspection outcomes among member authorities — an overseas manufacturing site already GMP-certified/inspected by another PIC/S-member authority (e.g., TGA, an EU/EEA authority, or others) can support a New Zealand sponsor's compliance demonstration without a separate ground-up Medsafe inspection, subject to Medsafe's own risk-based assessment. This is a PIC/S-wide convention, not something unique to New Zealand's implementation — flagged here so it is not mistaken for an NZ-specific distinguishing feature; the same reliance mechanism applies to every PIC/S member, including Australia.	General PIC/S mutual-reliance principle (secondary-sourced this session — no Medsafe-specific policy page was independently read verifying NZ's exact risk-based criteria)	Overseas manufacturing site's current GMP certificate/inspection report from a recognized PIC/S-member authority, cross-referenced against the sponsor's own supply-chain documentation	[REPRESENTATIVE] A sponsor relying on an overseas GMP certificate that has expired, or that was issued by a non-PIC/S-member authority Medsafe does not recognize, is the practical failure mode — a document-analysis check should verify both the certificate's currency and the issuing authority's PIC/S-membership status, not just its existence.

PART B — Substantive GMP content: PIC/S PE009-14, as adopted (New Zealand Code of GMP, Part I — medicinal products)

This entire Part is PIC/S PE009-14 chapter text (equivalent in origin and, in most chapters, near-identical wording to the EU GMP Vol. 4 Part I chapters already modeled clause-by-clause in docs/gmp-gdp-rubric.md). Rather than re-deriving each clause and its failure pattern from scratch, this rubric cites the PE009-14 chapter, notes the version New Zealand actually has in force (2018-vintage text, in force in NZ since 3 May 2021 — materially older than the EU's current post-2023 Annex 1 rewrite, see row 11), and cross-references the equivalent already-documented EU-GMP row.

#	Requirement (PE009-14 chapter)	Citation	Evidence	Common failure pattern
6	Chapter 1 — Pharmaceutical Quality System: documented PQS, senior-management leadership/participation, change control (pre-implementation evaluation + post-implementation review), deviation root-cause analysis, self-inspection/management review, Product Quality Review.	PIC/S PE009-14, Part I, Ch. 1 (as adopted, NZ Code of GMP Part I, in force 3 May 2021)	Same evidence types as `gmp-gdp-rubric.md` row 1–6 (Quality Manual, org chart, change-control log, deviation/CAPA records, self-inspection schedule, PQR reports)	[ANALOGOUS] — borrows MHRA's 2015 finding that Quality System is the single most-cited GMP deficiency group (27 Critical/293 Major/555 Other) documented in `gmp-gdp-rubric.md` row 1; the underlying PIC/S Chapter 1 text NZ has adopted is materially the same clause set.
7	Chapter 4 — Documentation: ALCOA-consistent records — contemporaneous, attributable, legible, corrections traceable not obscured; retention and protection of records; procedures/forms must reflect actual practice.	PIC/S PE009-14, Part I, Ch. 4	Signed/dated batch records with visible original entries under any correction; document-control register	[ANALOGOUS] — borrows `gmp-gdp-rubric.md` row 7–10's MHRA verbatim examples (pencil/tippex corrections, records partially burnt/awaiting destruction, uncontrolled hand-written SOPs) as the same underlying clause.
8	Chapter 5 — Production: cross-contamination risk assessment (toxicity/potency-driven), supplier/API qualification with matching technical agreements, validated cleaning procedures with scientifically justified limits.	PIC/S PE009-14, Part I, Ch. 5	Cross-contamination risk assessment; approved supplier list; cleaning validation report	[ANALOGOUS] — borrows `gmp-gdp-rubric.md` rows 11–13's MHRA examples.
9	Chapter 6 — Quality Control: stability/OOT/OOS trend review, actual (not merely ticked) review of electronic QC data, no pre-completed test sheets.	PIC/S PE009-14, Part I, Ch. 6	Stability trend reports; electronic-data review sign-offs tied to specific file IDs; timestamped LIMS/paper audit trail	[ANALOGOUS] — borrows `gmp-gdp-rubric.md` rows 14–16's MHRA verbatim data-integrity examples.
10	Chapter 7 — Outsourced Activities: written Contract Giver/Acceptor agreement, pre-qualification and ongoing performance review of the Acceptor, Giver-side review of outsourced records/results (not blind CoA acceptance), contractual audit rights.	PIC/S PE009-14, Part I, Ch. 7	Signed technical/quality agreement; pre-qualification audit report; Giver-side batch-record/CoA review evidence	[ANALOGOUS] — borrows `gmp-gdp-rubric.md` rows 17–20's MHRA examples. This chapter is also where Row 3 above (GMP Certificates for NZ contract testing labs) and Row 5 (overseas manufacturing-site reliance) most directly interact with the outsourcing-oversight documentation a Regscribe customer would need.
11	Annex 1 — Manufacture of Sterile Medicinal Products: New Zealand's adopted Annex 1 is the version current as of PE009-14 (in force in NZ since 3 May 2021, itself carrying forward PIC/S's then-current 2015-vintage Annex 1 text) — not the fully rewritten, Contamination-Control-Strategy-based EU GMP Annex 1:2023 that this project separately models in `docs/eu-annex1-rubric.md`. This is the single most consequential version-currency finding in this rubric. A sterile-manufacturing document set that satisfies the CCS-based 2023 EU Annex 1 rubric is materially more than what NZ's currently-adopted PE009-14 Annex 1 requires — but the reverse is not safe to assume, and Regscribe must not silently substitute the `eu-annex1-rubric.md` scoring logic for a Medsafe-only compliance claim without flagging the version gap to the customer. Whether PIC/S itself, and in turn Medsafe, has since adopted a CCS-aligned Annex 1 revision was not confirmed this session — see Gaps.	PIC/S PE009-14, Part I, Annex 1 (as adopted, NZ Code of GMP)	Sterile-manufacturing facility/process documentation checked against the 2015-vintage Annex 1 structure (grade A/B/C/D classification, media fill, etc.) rather than the 2023 CCS framework, unless a newer NZ Code update is confirmed	[UNVERIFIED — flagged, not used] for any claim that NZ has since moved to a CCS-based Annex 1 — not confirmed this session, not scored as if true.
12	Excluded Annexes 3, 4, 5, 12, 16, 18 — New Zealand's Code of GMP Part I explicitly does not incorporate these six PIC/S annexes. No Medsafe-published reasoning was found for the specific exclusions (unlike the Annex 14 plasma-fractionation example in Sources), so the following is regulatory-structure inference, not a quoted Medsafe justification: Annex 3 (Radiopharmaceuticals) and Annex 12 (Ionising Radiation) plausibly reflect the absence of domestic radiopharmaceutical/irradiation manufacturing subject to Medsafe's manufacturing-licence regime; Annexes 4 and 5 (Veterinary Medicinal Products, immunological and non-immunological) plausibly reflect that veterinary medicines in New Zealand are regulated under a different statute (the Agricultural Compounds and Veterinary Medicines Act 1997, administered by MPI, not Medsafe/the Medicines Act 1981) — the Medicines Act's own scope is human medicines; Annex 16 (Certification by a Qualified Person and Batch Release) reflects that the EU-specific legal concept of a statutorily-defined "Qualified Person" with personal certification liability has no direct equivalent role in New Zealand's licensing framework; Annex 18 (GMP for Active Pharmaceutical Ingredients) is plausibly not incorporated as an annex because New Zealand instead publishes API requirements as a freestanding Part II of its own Code, rather than folding API-GMP in as an annex to the medicinal-products Part I.	New Zealand Code of GMP (annex-inclusion list per NZRGMPart1.asp, cross-checked against WebSearch summary of the exclusion list)	Confirm which annex a document-analysis finding is being scored against actually forms part of the NZ Code before citing it — e.g., do not score a New Zealand human-medicine manufacturing site against Annex 4/5 veterinary provisions, and do not expect an NZ manufacturing licensee to hold Annex-16-style QP certification documentation, since neither is part of the adopted NZ Code	[REPRESENTATIVE] The most likely Regscribe scoring error here is applying an EU-GMP or Australia rubric row that references an excluded annex (most plausibly Annex 16 QP-certification language, since "Qualified Person" appears throughout EU/UK GMP discourse) to an NZ-only document set — this is a category error specific to the annex-subset difference, not a shared PIC/S-substance issue.
13	Part II — Active Pharmaceutical Ingredients: New Zealand publishes API manufacturing/quality-control requirements as a standalone Part II of its own Code (rather than incorporating PIC/S Annex 18 by reference), covering the same subject matter (API-specific quality system, materials management, production, laboratory controls, validation, documentation, contract manufacturing, complaints/recalls, retest/reprocessing).	New Zealand Code of GMP, Part II (existence and title confirmed via NZRGMPart1.asp; clause-level text not independently fetched/read this session)	API-specific SOPs/records checked against Part II's structure rather than the medicinal-product Part I structure	[REPRESENTATIVE] Applying Part I (finished-product) evidence expectations to an API manufacturing site, rather than the API-specific Part II structure, understates what is actually required (or, conversely, demands finished-product-specific artifacts — e.g., patient-facing labelling controls — that do not apply to bulk API) — the same "wrong document-category applied" risk flagged in the Japan GMP rubric's Chapter 2 Section 2 (APIs) treatment.

PART C — Recalls (New Zealand-specific instrument, Part V of the NZ Code)

#	Requirement	Citation	Evidence	Common failure pattern
14	Recall governance: every New Zealand manufacturer, supplier, and wholesaler must have a pre-determined recall system; all recalls must be carried out with Medsafe's knowledge and consent — sponsors are expected to discuss potential issues with Medsafe before initiating recall action, inform Medsafe as soon as possible of proposed actions, and have the draft recall notice reviewed and agreed by Medsafe before distribution. A final report (summarizing actions taken, healthcare-professional response, and preventive measures) is provided to Medsafe once the recall (typically six weeks to three months) is complete.	New Zealand Medicines and Medical Devices Recall Code (Sept 2015), read as GMP Part V of the NZ Code (per Medsafe's own framing)	Recall SOP naming the pre-notification-to-Medsafe step explicitly (not merely a generic internal recall procedure); draft recall notice with Medsafe sign-off evidence predating distribution; final report to Medsafe	[REPRESENTATIVE] A recall procedure that reads as a generic corporate recall SOP with no explicit Medsafe pre-notification/consent step is the NZ-specific gap here — this is a materially more regulator-involved recall-initiation model than, e.g., the EU GDP Chapter 6 model (`gmp-gdp-rubric.md` row 43), which requires annual effectiveness evaluation of recall arrangements but does not require the regulator's advance consent to initiate a specific recall. Do not treat the EU GDP recall row as a substitute check for this one.
15	Public recall transparency: since 1 July 2012, summary information on all New Zealand recall actions is available via the public, searchable Medsafe Online Recalls Database — a genuinely NZ-specific transparency mechanism (structurally comparable in purpose, though not in format or data depth, to MHRA's published GMP/GDP deficiency-trend reports used as this project's EU sourcing backbone, and to the FDA public disqualified-facility list referenced in `cfr58-glp-rubric.md`). This database was not queried this session — see Gaps.	Medsafe Online Recalls Database, medsafe.govt.nz/hot/recalls/recallsearch.asp	Cross-reference any manufacturer/product under document-analysis review against this public database as a pre-screening step	[REPRESENTATIVE] Unweighted pending mining of the actual database — flagged as the highest-value follow-up in Gaps below, since this is the one Medsafe-published data source structurally capable of yielding real, NZ-specific, citable failure patterns the way MHRA's deficiency data does for the EU rubric.

Cross-reference: New Zealand vs. Australia (TGA) vs. EU GMP vs. plain PIC/S PE009

Concept	New Zealand (Medsafe)	Australia (TGA)	EU GMP Vol. 4 / plain PIC/S baseline
Underlying GMP text	PIC/S PE009-14 (2018 vintage), in force in NZ since 3 May 2021, with Annexes 3/4/5/12/16/18 excluded and Part II (API) published as a standalone document	PIC/S PE009 adoption under the Therapeutic Goods Act 1989 — see companion `docs/au-gmp-rubric.md` for TGA's specific version/annex subset; not assumed identical to NZ's without checking that document	EU GMP Vol. 4 Part I (Ch. 1–9) + Annexes — the historically-linked but independently-maintained text PIC/S PE009 tracks with a lag
Legal instrument	Licence to Manufacture / Licence to Pack (Medicines Act 1981 s 17, Medicines Regulations 1984 reg 45–46) + separate GMP Certificate for contract testing labs	TGA Manufacturing Licence / GMP Clearance (see `au-gmp-rubric.md`)	Manufacturing/Import Authorisation (national competent authority) + QP batch certification (Annex 16)
Regulator-agency relationship	Medsafe — part of the Ministry of Health; not merged with TGA despite the long-discussed, never-implemented joint ANZTPA scheme and the NZ–Australia Mutual Recognition Agreement	TGA — part of Australia's Department of Health; separate statute, separate licensing regime	National competent authorities under EU pharmaceutical legislation
Sterile-manufacturing annex currency	PE009-14 Annex 1 (2015-vintage text) — not confirmed to reflect the CCS-based Annex 1:2023 rewrite (see row 11)	Not established in this session — check `au-gmp-rubric.md`	Annex 1:2023 (fully rewritten, CCS-based) — see `docs/eu-annex1-rubric.md`
Recall regime	Medsafe pre-notification-and-consent model (NZ Recall Code, Part V of NZ GMP Code) + public Medsafe Online Recalls Database since 2012	Not established in this session — check `au-gmp-rubric.md`	EU GDP Ch. 6 — annual effectiveness evaluation, no advance-consent requirement (`gmp-gdp-rubric.md` rows 42–44)
Veterinary/QP/API annex handling	Veterinary excluded (separate ACVM Act/MPI regime); no QP-certification annex; API handled as a standalone Part II, not an annex	Not established in this session — check `au-gmp-rubric.md`	Veterinary covered by Annexes 4/5; QP certification covered by Annex 16; API covered by Annex 18

Recommendation: extend this project's shared "Evidence Type" layer with two NZ-specific tags — nz_gmp_certificate (contract testing laboratories) and nz_recall_medsafe_consent (the pre-notification/consent recall step) — rather than building a fifth parallel evidence taxonomy. Every other substantive row in this rubric (Chapters 1/4/5/6/7, most annexes) should reuse the Evidence Type nodes already defined in gmp-gdp-rubric.md, since the underlying PIC/S-descended clause text is the same.

Gaps / follow-ups before this goes into production scoring

No named, verifiable Medsafe GMP enforcement action or GMP-attributed recall was found this session — the single biggest gap in this document, and worse than every other country-GMP rubric in this project (EU has MHRA deficiency-trend data; Japan has Kobayashi Kako/Nichi-Iko; US GLP has IBT/Craven Labs). Recommend a dedicated follow-up session that actually queries the Medsafe Online Recalls Database (medsafe.govt.nz/hot/recalls/recallsearch.asp — a search interface, not minable via a single WebFetch) for real, named, GMP-attributable NZ recall cases, to upgrade every [ANALOGOUS] failure-pattern cell above to a genuine NZ example where one exists.
legislation.govt.nz blocked direct WebFetch with HTTP 403 on every attempt this session (Medicines Act 1981 and Medicines Regulations 1984 both affected) — a known bot-blocking pattern also seen with eCFR.gov in this project's US rubrics. Section/regulation numbers and titles above (ss 17/37/52; regs 45/46) are sourced from search-result snippets/page titles, not from an independently-read full primary text. Recommend a follow-up session using a different fetch approach (e.g., NZLII mirror, or a text-in-browser tool) to read the actual clause text of these sections/regulations before treating any specific wording (beyond the confirmed section/regulation titles) as citable.
Whether New Zealand has since moved its Annex 1 adoption to the CCS-based EU GMP Annex 1:2023 structure was not confirmed this session (row 11) — the Medsafe pages fetched this session confirm PE009-14 (2018 vintage) as the version brought into force 3 May 2021, and no newer NZ Code update (to PE009-16 or later) was found via WebSearch, but a dedicated PIC/S-version-history check (PIC/S's own site, picscheme.org, was not directly fetched this session despite being named in the task brief) would materially de-risk this finding. Recommend fetching picscheme.org's own PE009 version-history page to establish (a) what the actual current PIC/S PE009 version number is as of 2026, and (b) whether NZ has a pending or completed update beyond PE009-14.
PIC/S's own site (picscheme.org) was not directly fetched this session, despite being named as a target in the task brief — all PIC/S-version findings above are Medsafe-page-sourced, not cross-checked against PIC/S's own authoritative version list. This is a real gap given how version-sensitive this entire rubric is (see rows 6–13, 11 especially). Recommend as the top follow-up alongside item 3.
The New Zealand Medicines and Medical Devices Recall Code (Sept 2015 PDF) and the GRTPNZ "Manufacture of Medicines" / "Overview of Medicine Regulation" PDFs were found but not cleanly read in full this session — WebFetch returned high-level paraphrases rather than extracted verbatim clause text for all three. Rows 14–15 and the licensing detail in Part A are accordingly summary-level, not clause-verified. Recommend re-fetching these three PDFs with a page-by-page or OCR approach if they resist clean text extraction, following the same pattern used successfully for Japan's scanned-PDF GMP Ordinance in jp-gmp-rubric.md.
No reasoning for the exclusion of PIC/S Annexes 3, 4, 5, 12, 16, and 18 was found in any Medsafe-published document this session (row 12) — the explanations given in this rubric are regulatory-structure inference (veterinary medicines sit under a different NZ statute; no QP-equivalent role in NZ law; API handled via a standalone Part II instead) and are clearly labeled as such, not as quoted Medsafe reasoning. A follow-up should search for any Medsafe consultation document (the "Review of Code for GMP" page yielded the Annex-14 plasma-fractionation example but nothing on the excluded six) that states this explicitly.
Overall distinctiveness assessment, stated plainly per this project's anti-padding rule: substantively, New Zealand's GMP requirements ARE, to the best of what this session could verify, near-identical to what Australia's TGA (and, one step further removed, the EU) apply, because all derive from the same PIC/S PE009 text family. The genuinely distinctive New Zealand content this rubric found is: (a) the specific PE009-14/2018-vintage version and the specific six excluded annexes currently in force (a different subset/vintage than may apply elsewhere), (b) the separate "GMP Certificate" instrument for contract testing laboratories, (c) the Medsafe pre-notification-and-consent recall model, and (d) the fact that NZ and Australia remain legally separate regulators despite the abortive ANZTPA merger effort. That is a real but narrow band of distinctive content — this rubric does not manufacture additional distinctiveness beyond it.

New Zealand GMP (Medsafe / NZ Code of GMP)