# Vercy AI instruction - YAML 1.2 (JSON-compatible) { "vercy": "1.0-draft", "publication": { "status": "published", "adjudicationStatus": "reviewable-draft", "publishableCanonical": false, "generatedAt": "2026-10-06T22:01:37Z", "synthesisSha256": "6a8c5b741878fd02ac1a0cb6862497e51b2ed83e323d9af4d2cf1f50f5853625", "providerMode": "single-provider-waiver", "providers": [ "Codex" ], "waivedProviders": [ "Claude", "Grok" ] }, "metaModel": { "id": "WM-OBJ-005", "registryId": "vr.wm-obj-005", "name": "Medicinal Product", "version": "0.1.0-reviewable-draft", "previousVersions": [], "entryKind": "entity", "family": "World Models", "category": "Physical world and living systems", "industry": [ "Cross-industry" ], "domain": [ "PHY.OBJ.DRUG" ], "tags": [ "medicinal", "product", "phy.obj.drug" ], "status": "published" }, "canonicalUrl": "https://ver.cy/models/wm-obj-005-medicinal-product/", "sourceUrl": "https://github.com/ver-cy/world-models/tree/feat/mega-model-registry/research/runs/wm-obj-005", "model": { "registry_id": "vr.wm-obj-005", "model_id": "WM-OBJ-005", "name": "Medicinal Product", "entry_kind": "entity", "purpose": "Maintain a governed medicinal product definition with attributable composition, presentation, regulatory context and links to safety and supply evidence.", "scope_statement": "One persistent human medicinal product definition, with explicitly scoped identity and versioned assertions. Includes products before authorization. This reviewable draft is a research design, not a clinical, regulatory or pack-verification service.", "in_scope": [ "Product names and scoped identifiers, classification mappings and declared ingredient/form/strength properties", "Jurisdictional authorization and policy assertions, product information references and accountable role links", "Package-definition, batch, pack, quality, availability and vigilance evidence references", "Local revision, evidence quality, privacy, access and retirement rules" ], "out_of_scope": [ "Raw chemical or controlled substances without a medicinal product context; chemistry, synthesis, extraction, procurement and diversion instructions", "Patient diagnosis, dosing, prescribing, dispensing, administration, substitution and individual adverse-event case management", "Batch manufacture, release, recall execution, pack authentication/decommissioning, warehouse operations and real-time stock", "Veterinary, device-led combination, advanced therapy, radiopharmaceutical, traditional, homeopathic and bespoke preparation profiles beyond explicitly recorded gaps", "Execution of regulatory decisions or claims of legal compliance and ISO/FHIR conformance" ], "boundary_notes": [ { "neighbor": "Legacy M5", "distinction": "Legacy medicine/substance root is narrowed to product definition. A controlled substance is not automatically a medicinal product. Legacy maximal cardinalities, conformance claims and verification guarantees are not inherited.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-008" ] }, { "neighbor": "WM-MAT-001 Chemical Substance", "distinction": "Reference substance identity and external hazard evidence; retain only product-specific role and declared quantity context.", "source_refs": [ "SRC-001", "SRC-002" ] }, { "neighbor": "WM-OBJ-001 Physical Item Instance and WM-MAT-004 Material Batch / Lot", "distinction": "Individual packs and production lots remain separate masters; product definition references their evidence without owning physical lifecycle.", "source_refs": [ "SRC-002", "SRC-008" ] }, { "neighbor": "WM-OBJ-002 Product Type / Catalog Item and WM-OBJ-003 Tradable Offer / Commodity view", "distinction": "Product-type alignment is optional. The legacy extension of M3 is not inherited because its successor is an offer view, not the generic product definition.", "source_refs": [ "SRC-002", "SRC-004" ] }, { "neighbor": "WM-ACT-048 Medication Order / Administration", "distinction": "Medication orders, dispensing and administration retain clinical identity and authority. A product reference supplies context only.", "source_refs": [ "SRC-002", "SRC-006" ] }, { "neighbor": "Authorization, quality, vigilance and shortage source records", "distinction": "External records own decisions, evaluations and execution; this product retains scoped assertions and source references. No relation ledger rows for WM-OBJ-005 were present at freeze.", "source_refs": [ "SRC-003", "SRC-008", "SRC-009", "SRC-010" ] } ] }, "sources": [ { "id": "SRC-001", "title": "Data on medicines (ISO IDMP standards): Overview", "organization": "European Medicines Agency", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview", "version_or_date": "Undated overview accessed 2026-10-07; normative editions not inspected", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "SPOR domains and product lifecycle scope; overview only, not proof of ISO conformance." }, { "id": "SRC-002", "title": "MedicinalProductDefinition - FHIR v5.0.0", "organization": "HL7 International", "url": "https://hl7.org/fhir/R5/medicinalproductdefinition.html", "version_or_date": "FHIR R5 5.0.0; Trial Use resource", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "Product definition separated from physical manifestations, packaging and direct patient care; conceptual alignment only." }, { "id": "SRC-003", "title": "Directive 2001/83/EC - consolidated text", "organization": "European Parliament and Council", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02001L0083-20250101", "version_or_date": "Consolidation dated 2025-01-01; selected provisions reviewed", "source_type": "legislation", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "Articles 11, 70 and 71 and Annex I support product information, prescription classification and role references; national applicability unverified." }, { "id": "SRC-004", "title": "National Drug Code Directory", "organization": "United States Food and Drug Administration", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory", "version_or_date": "Live explanatory page accessed 2026-10-07; dataset not downloaded", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "Listing identifiers and reported marketing dates do not prove approval, verified content or current stock." }, { "id": "SRC-005", "title": "Anatomical Therapeutic Chemical (ATC) Classification", "organization": "World Health Organization", "url": "https://www.who.int/tools/atc-ddd-toolkit/atc-classification", "version_or_date": "Toolkit page accessed 2026-10-07; code release not pinned", "source_type": "classifier", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "Classification hierarchy is distinct from a unique regulated product identifier." }, { "id": "SRC-006", "title": "Defined Daily Dose (DDD)", "organization": "World Health Organization", "url": "https://www.who.int/tools/atc-ddd-toolkit/about-ddd", "version_or_date": "Toolkit page accessed 2026-10-07; assignments not imported", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "DDD is a drug utilization measurement unit and is not an individual prescribed dose." }, { "id": "SRC-007", "title": "RxNorm Overview", "organization": "United States National Library of Medicine", "url": "https://www.nlm.nih.gov/research/umls/rxnorm/overview.html", "version_or_date": "Live overview accessed 2026-10-07; terminology release not downloaded", "source_type": "first-party-doc", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "Normalized drug concepts, ingredient/strength/form granularity and concept history inform qualified mappings." }, { "id": "SRC-008", "title": "Commission Delegated Regulation (EU) 2016/161", "organization": "European Commission", "url": "https://eur-lex.europa.eu/eli/reg_del/2016/161/oj/eng", "version_or_date": "Original act of 2015-10-02 published 2016-02-09; amendments not reconciled", "source_type": "legislation", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "Article 4 distinguishes product code, serial, batch and expiry; verification is profile dependent and external." }, { "id": "SRC-009", "title": "Signal management", "organization": "European Medicines Agency", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management", "version_or_date": "Live page accessed 2026-10-07; linked guidance not exhaustively reviewed", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "A signal is not itself proof of causality; product links preserve assessment and communication provenance." }, { "id": "SRC-010", "title": "Public information on medicine shortages", "organization": "European Medicines Agency", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/public-information-medicine-shortages", "version_or_date": "Live overview accessed 2026-10-07; individual notices not assessed", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:59:42Z", "relevance": "Regional and national shortage sources require market, time and coverage qualifiers." } ], "structure": { "bundles": [ { "id": "identity", "name": "Product identity", "description": "Recognize one regulated product definition without collapsing names, classes or physical instances.", "rationale": "Proposed grouping of product-owned context; external master records remain referenced.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007" ], "layers": [ { "id": "identification", "name": "Names and identifiers", "description": "Proposed context for a persistent product definition and its revisions. Identity granularity is set by an adopting profile; names alone cannot merge records.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ], "findings": [ { "id": "product-identity", "name": "Scoped product identity", "description": "Proposed context for a persistent product definition and its revisions. Identity granularity is set by an adopting profile; names alone cannot merge records.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ], "questions": [ { "id": "product-identity-q1", "text": "Which authoritative product identifier and namespace distinguish this definition from a substance, package type and individual pack?", "kind": "identity", "answer_data": [ "identifier-set", "Master namespace, value, assigning authority, jurisdiction, granularity and provisional-ID reason" ] }, { "id": "product-identity-q2", "text": "Which human-use product scope and development or regulatory category apply to this record?", "kind": "classification", "answer_data": [ "scope-category", "Code, scheme, release, human-use scope and exception basis" ] }, { "id": "product-identity-q3", "text": "Which official name variants, languages and evidence revisions support identification without relying on appearance alone?", "kind": "provenance", "answer_data": [ "name-evidence", "Names, language, territory, evidence locator and revision" ] } ], "data_elements": [ { "id": "product-identity-identifier-set", "name": "identifier-set", "description": "Master namespace, value, assigning authority, jurisdiction, granularity and provisional-ID reason. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "identifier", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ] }, { "id": "product-identity-scope-category", "name": "scope-category", "description": "Code, scheme, release, human-use scope and exception basis. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "code", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ] }, { "id": "product-identity-name-evidence", "name": "name-evidence", "description": "Names, language, territory, evidence locator and revision. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ] } ], "artifacts": [ { "id": "product-identity-evidence", "name": "Scoped product identity evidence index", "description": "Local index of attributed references and review outcomes for scoped product identity. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ] } ], "inline_only_rationale": null } ] }, { "id": "classification", "name": "Terminology alignment", "description": "Store explicit mapping relationships at the source concept granularity. ATC class membership, RxNorm concepts and product listing identifiers serve different purposes; none proves clinical interchangeability.", "source_refs": [ "SRC-004", "SRC-005", "SRC-006", "SRC-007" ], "findings": [ { "id": "classification-mappings", "name": "Qualified terminology mappings", "description": "Store explicit mapping relationships at the source concept granularity. ATC class membership, RxNorm concepts and product listing identifiers serve different purposes; none proves clinical interchangeability.", "source_refs": [ "SRC-004", "SRC-005", "SRC-006", "SRC-007" ], "questions": [ { "id": "classification-mappings-q1", "text": "What mapping relation and version connect this product to an ATC, RxNorm or other external concept?", "kind": "interoperability", "answer_data": [ "mapping-record", "Source and target identifiers, releases, relation type, reviewer and loss notes" ] }, { "id": "classification-mappings-q2", "text": "Which ambiguity or change in strength, form or ingredient prevents automatic equivalence or identity merging?", "kind": "validation", "answer_data": [ "mapping-exceptions", "Unmatched attributes, split/merge history and adjudication reference" ] }, { "id": "classification-mappings-q3", "text": "How is any DDD annotation marked as a utilization metric so it cannot become patient dosing advice?", "kind": "constraint", "answer_data": [ "ddd-context", "ATC code, route, unit, release and non-prescribing purpose" ] } ], "data_elements": [ { "id": "classification-mappings-mapping-record", "name": "mapping-record", "description": "Source and target identifiers, releases, relation type, reviewer and loss notes. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-004", "SRC-005", "SRC-006", "SRC-007" ] }, { "id": "classification-mappings-mapping-exceptions", "name": "mapping-exceptions", "description": "Unmatched attributes, split/merge history and adjudication reference. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-004", "SRC-005", "SRC-006", "SRC-007" ] }, { "id": "classification-mappings-ddd-context", "name": "ddd-context", "description": "ATC code, route, unit, release and non-prescribing purpose. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-004", "SRC-005", "SRC-006", "SRC-007" ] } ], "artifacts": [ { "id": "classification-mappings-evidence", "name": "Qualified terminology mappings evidence index", "description": "Local index of attributed references and review outcomes for qualified terminology mappings. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-004", "SRC-005", "SRC-006", "SRC-007" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "composition", "name": "Composition and presentation", "description": "Describe declared product properties with explicit substance and quantity context.", "rationale": "Proposed grouping of product-owned context; external master records remain referenced.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-007" ], "layers": [ { "id": "ingredients", "name": "Ingredient declarations", "description": "References identify active ingredients and relevant excipients. The product owns their declared role and formulation context, while chemical identity and hazards remain substance-owned.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003" ], "findings": [ { "id": "ingredient-roles", "name": "Substances and ingredient roles", "description": "References identify active ingredients and relevant excipients. The product owns their declared role and formulation context, while chemical identity and hazards remain substance-owned.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003" ], "questions": [ { "id": "ingredient-roles-q1", "text": "Which substance reference and role are declared for each ingredient in this product revision?", "kind": "composition", "answer_data": [ "ingredient-links", "Substance master reference, role, component, declaration status and source revision" ] }, { "id": "ingredient-roles-q2", "text": "Which excipient or ingredient declaration is incomplete, disputed or outside the evidence coverage?", "kind": "quality", "answer_data": [ "declaration-gaps", "Unknown versus absent, completeness scope, exception and resolution owner role" ] }, { "id": "ingredient-roles-q3", "text": "How are combination-product components kept distinct without importing their chemical or device lifecycle?", "kind": "relationship", "answer_data": [ "component-links", "Component definition references, product-specific role and unresolved binding" ] } ], "data_elements": [ { "id": "ingredient-roles-ingredient-links", "name": "ingredient-links", "description": "Substance master reference, role, component, declaration status and source revision. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003" ] }, { "id": "ingredient-roles-declaration-gaps", "name": "declaration-gaps", "description": "Unknown versus absent, completeness scope, exception and resolution owner role. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003" ] }, { "id": "ingredient-roles-component-links", "name": "component-links", "description": "Component definition references, product-specific role and unresolved binding. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003" ] } ], "artifacts": [ { "id": "ingredient-roles-evidence", "name": "Substances and ingredient roles evidence index", "description": "Local index of attributed references and review outcomes for substances and ingredient roles. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003" ] } ], "inline_only_rationale": null } ] }, { "id": "strength-form", "name": "Strength, form and route", "description": "Proposed quantity tuples preserve numerator, denominator, units and basis substance. Manufactured form and administrable form are distinct; no conversion or preparation procedure is authorized here.", "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ], "findings": [ { "id": "presentation-definition", "name": "Declared presentation properties", "description": "Proposed quantity tuples preserve numerator, denominator, units and basis substance. Manufactured form and administrable form are distinct; no conversion or preparation procedure is authorized here.", "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ], "questions": [ { "id": "presentation-definition-q1", "text": "What strength expression, basis substance and denominator apply before or after any declared transformation?", "kind": "measurement", "answer_data": [ "strength-tuple", "Numerator value/unit, denominator value/unit, basis substance, range and reference state" ] }, { "id": "presentation-definition-q2", "text": "Which manufactured form, administrable form, unit of presentation and route are declared with terminology versions?", "kind": "classification", "answer_data": [ "form-route", "Form and route codes, code systems, releases and component binding" ] }, { "id": "presentation-definition-q3", "text": "Which presentation changes require a new product identity versus a revision under the adopting authority profile?", "kind": "exception", "answer_data": [ "identity-change-rule", "Profile, changed attributes, authority decision reference and unresolved cases" ] } ], "data_elements": [ { "id": "presentation-definition-strength-tuple", "name": "strength-tuple", "description": "Numerator value/unit, denominator value/unit, basis substance, range and reference state. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] }, { "id": "presentation-definition-form-route", "name": "form-route", "description": "Form and route codes, code systems, releases and component binding. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] }, { "id": "presentation-definition-identity-change-rule", "name": "identity-change-rule", "description": "Profile, changed attributes, authority decision reference and unresolved cases. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] } ], "artifacts": [ { "id": "presentation-definition-evidence", "name": "Declared presentation properties evidence index", "description": "Local index of attributed references and review outcomes for declared presentation properties. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "regulatory", "name": "Regulatory context", "description": "Attach authoritative decisions and scoped restrictions without executing legal or clinical actions.", "rationale": "Proposed grouping of product-owned context; external master records remain referenced.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004" ], "layers": [ { "id": "authorization", "name": "Authorization standing", "description": "Authorization is an attributed assertion with market and effective period, distinct from record status and directory listing. Pre-authorization products remain representable. No universal one-authorization-per-country constraint is imposed.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004" ], "findings": [ { "id": "authorization-evidence", "name": "Market authorization assertions", "description": "Authorization is an attributed assertion with market and effective period, distinct from record status and directory listing. Pre-authorization products remain representable. No universal one-authorization-per-country constraint is imposed.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004" ], "questions": [ { "id": "authorization-evidence-q1", "text": "Which decision, issuing authority and legal pathway support the stated authorization status for this product and territory?", "kind": "authority", "answer_data": [ "authorization-record", "Authority reference, decision identifier, jurisdiction, pathway, status and source" ] }, { "id": "authorization-evidence-q2", "text": "When did each authorization assertion take effect and when was its evidence observed?", "kind": "temporal", "answer_data": [ "authorization-times", "Effective interval, decision date, observation timestamp and precision" ] }, { "id": "authorization-evidence-q3", "text": "How are pending, refused, suspended, withdrawn, unknown and conflicting authorization assertions kept separate from marketing availability?", "kind": "state", "answer_data": [ "authorization-conflicts", "Competing assertions, evidence priority, supersession and review state" ] } ], "data_elements": [ { "id": "authorization-evidence-authorization-record", "name": "authorization-record", "description": "Authority reference, decision identifier, jurisdiction, pathway, status and source. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004" ] }, { "id": "authorization-evidence-authorization-times", "name": "authorization-times", "description": "Effective interval, decision date, observation timestamp and precision. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004" ] }, { "id": "authorization-evidence-authorization-conflicts", "name": "authorization-conflicts", "description": "Competing assertions, evidence priority, supersession and review state. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004" ] } ], "artifacts": [ { "id": "authorization-evidence-evidence", "name": "Market authorization assertions evidence index", "description": "Local index of attributed references and review outcomes for market authorization assertions. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004" ] } ], "inline_only_rationale": null } ] }, { "id": "restrictions", "name": "Prescription and controlled status", "description": "Policy-only references describe prescription and controlled status where applicable. No schedule lookup table, acquisition instructions or operational handling procedures are supplied.", "source_refs": [ "SRC-003" ], "findings": [ { "id": "restriction-profile", "name": "Jurisdictional policy restrictions", "description": "Policy-only references describe prescription and controlled status where applicable. No schedule lookup table, acquisition instructions or operational handling procedures are supplied.", "source_refs": [ "SRC-003" ], "questions": [ { "id": "restriction-profile-q1", "text": "Which jurisdiction-specific prescription or controlled-status decision applies to this formulation and presentation?", "kind": "constraint", "answer_data": [ "restriction-reference", "Jurisdiction, status code, authority, legal reference and product scope" ] }, { "id": "restriction-profile-q2", "text": "What effective period and reviewed legal version govern each restriction assertion?", "kind": "temporal", "answer_data": [ "restriction-period", "Effective dates, legal version, reviewer role and review deadline" ] }, { "id": "restriction-profile-q3", "text": "What unresolved exemption, cross-border difference or applicability question requires qualified review before use?", "kind": "exception", "answer_data": [ "restriction-review", "Issue, applicable profile reference, evidence gap and qualified reviewer role" ] } ], "data_elements": [ { "id": "restriction-profile-restriction-reference", "name": "restriction-reference", "description": "Jurisdiction, status code, authority, legal reference and product scope. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003" ] }, { "id": "restriction-profile-restriction-period", "name": "restriction-period", "description": "Effective dates, legal version, reviewer role and review deadline. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003" ] }, { "id": "restriction-profile-restriction-review", "name": "restriction-review", "description": "Issue, applicable profile reference, evidence gap and qualified reviewer role. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003" ] } ], "artifacts": [ { "id": "restriction-profile-evidence", "name": "Jurisdictional policy restrictions evidence index", "description": "Local index of attributed references and review outcomes for jurisdictional policy restrictions. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-003" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "information", "name": "Product information", "description": "Preserve attributable product information and its use limits.", "rationale": "Proposed grouping of product-owned context; external master records remain referenced.", "source_refs": [ "SRC-003", "SRC-008", "SRC-009" ], "layers": [ { "id": "clinical-label", "name": "Clinical particulars references", "description": "Index approved or proposed product information by evidence state. Clinical particulars are document references, not a patient-specific recommendation or an assessment of suitability.", "source_refs": [ "SRC-003", "SRC-009" ], "findings": [ { "id": "label-context", "name": "Indications and safety information", "description": "Index approved or proposed product information by evidence state. Clinical particulars are document references, not a patient-specific recommendation or an assessment of suitability.", "source_refs": [ "SRC-003", "SRC-009" ], "questions": [ { "id": "label-context-q1", "text": "Which product-information revision supplies indications, contraindications, warnings and interaction references for this market?", "kind": "evidence", "answer_data": [ "clinical-document", "Document master identifier, revision, jurisdiction, language and section locators" ] }, { "id": "label-context-q2", "text": "Is that product information approved, proposed, superseded or unverified, and what evidence supports that state?", "kind": "state", "answer_data": [ "label-state", "State, authority evidence, effective period and observation time" ] }, { "id": "label-context-q3", "text": "Which public or restricted view may expose the document without leaking patient reports or confidential assessment material?", "kind": "access", "answer_data": [ "label-view", "Audience, classification, permitted fields, redaction and policy reference" ] } ], "data_elements": [ { "id": "label-context-clinical-document", "name": "clinical-document", "description": "Document master identifier, revision, jurisdiction, language and section locators. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "reference", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-009" ] }, { "id": "label-context-label-state", "name": "label-state", "description": "State, authority evidence, effective period and observation time. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-009" ] }, { "id": "label-context-label-view", "name": "label-view", "description": "Audience, classification, permitted fields, redaction and policy reference. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-009" ] } ], "artifacts": [ { "id": "label-context-evidence", "name": "Indications and safety information evidence index", "description": "Local index of attributed references and review outcomes for indications and safety information. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-003", "SRC-009" ] } ], "inline_only_rationale": null } ] }, { "id": "storage-label", "name": "Storage and shelf-life declarations", "description": "Capture source-bound storage and shelf-life declarations at the product or presentation level. A storage declaration is not a measurement of a pack, nor a decision that an excursion is acceptable.", "source_refs": [ "SRC-003", "SRC-008" ], "findings": [ { "id": "storage-context", "name": "Labeled storage constraints", "description": "Capture source-bound storage and shelf-life declarations at the product or presentation level. A storage declaration is not a measurement of a pack, nor a decision that an excursion is acceptable.", "source_refs": [ "SRC-003", "SRC-008" ], "questions": [ { "id": "storage-context-q1", "text": "Which approved storage and shelf-life declaration applies to the sealed or opened presentation?", "kind": "requirement", "answer_data": [ "storage-declaration", "Condition, state, duration or source text, unit, evidence and jurisdiction" ] }, { "id": "storage-context-q2", "text": "What method, conditions, time, units and uncertainty accompany any linked observation relevant to a storage concern?", "kind": "measurement", "answer_data": [ "storage-observation-link", "External observation reference, measurement context and missing-data markers" ] }, { "id": "storage-context-q3", "text": "Who must assess an excursion or shelf-life ambiguity in the external quality system before any disposition is recorded?", "kind": "decision", "answer_data": [ "quality-review-link", "Qualified role, quality case reference and disposition evidence status" ] } ], "data_elements": [ { "id": "storage-context-storage-declaration", "name": "storage-declaration", "description": "Condition, state, duration or source text, unit, evidence and jurisdiction. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003", "SRC-008" ] }, { "id": "storage-context-storage-observation-link", "name": "storage-observation-link", "description": "External observation reference, measurement context and missing-data markers. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "reference", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-008" ] }, { "id": "storage-context-quality-review-link", "name": "quality-review-link", "description": "Qualified role, quality case reference and disposition evidence status. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "reference", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-008" ] } ], "artifacts": [ { "id": "storage-context-evidence", "name": "Labeled storage constraints evidence index", "description": "Local index of attributed references and review outcomes for labeled storage constraints. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-003", "SRC-008" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "traceability", "name": "Packaging and traceability references", "description": "Connect product definitions to separately mastered pack and quality evidence.", "rationale": "Proposed grouping of product-owned context; external master records remain referenced.", "source_refs": [ "SRC-002", "SRC-003", "SRC-008" ], "layers": [ { "id": "packaging", "name": "Package definitions and recognition", "description": "Record package-definition references and observed identification evidence separately. A barcode reading or matching appearance is an observation, not a guarantee of authenticity, quality or clinical suitability.", "source_refs": [ "SRC-002", "SRC-008" ], "findings": [ { "id": "package-definition", "name": "Package variants and identification evidence", "description": "Record package-definition references and observed identification evidence separately. A barcode reading or matching appearance is an observation, not a guarantee of authenticity, quality or clinical suitability.", "source_refs": [ "SRC-002", "SRC-008" ], "questions": [ { "id": "package-definition-q1", "text": "Which package definition, contents and presentation identifiers link to this product revision?", "kind": "composition", "answer_data": [ "package-links", "Package master reference, revision, component quantity/unit and territory" ] }, { "id": "package-definition-q2", "text": "What label or code observation supports a tentative product match and what mismatch remains?", "kind": "evidence", "answer_data": [ "recognition-evidence", "Observation reference, observed fields, method, time, confidence and mismatch" ] }, { "id": "package-definition-q3", "text": "Which authorized external verification result and scope support a pack-status assertion without equating it with batch release?", "kind": "validation", "answer_data": [ "verification-reference", "Pack master reference, verifier, response scope, timestamp and unresolved outcome" ] } ], "data_elements": [ { "id": "package-definition-package-links", "name": "package-links", "description": "Package master reference, revision, component quantity/unit and territory. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-002", "SRC-008" ] }, { "id": "package-definition-recognition-evidence", "name": "recognition-evidence", "description": "Observation reference, observed fields, method, time, confidence and mismatch. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-002", "SRC-008" ] }, { "id": "package-definition-verification-reference", "name": "verification-reference", "description": "Pack master reference, verifier, response scope, timestamp and unresolved outcome. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "reference", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-002", "SRC-008" ] } ], "artifacts": [ { "id": "package-definition-evidence", "name": "Package variants and identification evidence evidence index", "description": "Local index of attributed references and review outcomes for package variants and identification evidence. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-002", "SRC-008" ] } ], "inline_only_rationale": null } ] }, { "id": "batch-quality", "name": "Batch and recall links", "description": "The product stores references to batch, release, expiry and recall evidence. Batch masters, pack masters, recall cases and physical withdrawal execution are external. Unknown or stale evidence never becomes an all-clear.", "source_refs": [ "SRC-003", "SRC-008" ], "findings": [ { "id": "quality-notice-links", "name": "Batch and recall applicability", "description": "The product stores references to batch, release, expiry and recall evidence. Batch masters, pack masters, recall cases and physical withdrawal execution are external. Unknown or stale evidence never becomes an all-clear.", "source_refs": [ "SRC-003", "SRC-008" ], "questions": [ { "id": "quality-notice-links-q1", "text": "Which external batch or pack references are covered by an attributed quality or recall notice?", "kind": "relationship", "answer_data": [ "notice-scope", "Notice identifier, issuer, product identifiers, batch/pack selectors and market" ] }, { "id": "quality-notice-links-q2", "text": "When was the notice effective, revised or withdrawn and when was its applicability last checked?", "kind": "temporal", "answer_data": [ "notice-times", "Effective and observed times, notice revision and check scope" ] }, { "id": "quality-notice-links-q3", "text": "How is uncertain scope, contradictory release evidence or a failed verification response represented pending quality review?", "kind": "exception", "answer_data": [ "notice-exception", "Conflict, evidence references, unknown state and external review case" ] } ], "data_elements": [ { "id": "quality-notice-links-notice-scope", "name": "notice-scope", "description": "Notice identifier, issuer, product identifiers, batch/pack selectors and market. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003", "SRC-008" ] }, { "id": "quality-notice-links-notice-times", "name": "notice-times", "description": "Effective and observed times, notice revision and check scope. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-008" ] }, { "id": "quality-notice-links-notice-exception", "name": "notice-exception", "description": "Conflict, evidence references, unknown state and external review case. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003", "SRC-008" ] } ], "artifacts": [ { "id": "quality-notice-links-evidence", "name": "Batch and recall applicability evidence index", "description": "Local index of attributed references and review outcomes for batch and recall applicability. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-003", "SRC-008" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "monitoring", "name": "Market and safety monitoring", "description": "Attach market-specific observations and assessed safety evidence.", "rationale": "Proposed grouping of product-owned context; external master records remain referenced.", "source_refs": [ "SRC-004", "SRC-009", "SRC-010" ], "layers": [ { "id": "availability", "name": "Market availability", "description": "Represent dated availability and shortage notices with their reporting coverage. Authorization, marketing status, shortage status and local inventory are different assertions.", "source_refs": [ "SRC-004", "SRC-010" ], "findings": [ { "id": "availability-evidence", "name": "Availability and shortage assertions", "description": "Represent dated availability and shortage notices with their reporting coverage. Authorization, marketing status, shortage status and local inventory are different assertions.", "source_refs": [ "SRC-004", "SRC-010" ], "questions": [ { "id": "availability-evidence-q1", "text": "Which territory, presentation and reporting population are covered by an availability or shortage notice?", "kind": "spatial", "answer_data": [ "market-scope", "Market, presentation, reporting body, population and coverage limitations" ] }, { "id": "availability-evidence-q2", "text": "What observation interval, anticipated dates and update time qualify the notice?", "kind": "temporal", "answer_data": [ "availability-times", "Observed interval, expected dates, uncertainty, publication and ingestion time" ] }, { "id": "availability-evidence-q3", "text": "What prevents an absent shortage entry or a listed alternative from being read as available stock or therapeutic substitutability?", "kind": "constraint", "answer_data": [ "availability-limits", "Register completeness, stale-state rule and qualified external decision reference" ] } ], "data_elements": [ { "id": "availability-evidence-market-scope", "name": "market-scope", "description": "Market, presentation, reporting body, population and coverage limitations. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-004", "SRC-010" ] }, { "id": "availability-evidence-availability-times", "name": "availability-times", "description": "Observed interval, expected dates, uncertainty, publication and ingestion time. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-004", "SRC-010" ] }, { "id": "availability-evidence-availability-limits", "name": "availability-limits", "description": "Register completeness, stale-state rule and qualified external decision reference. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-004", "SRC-010" ] } ], "artifacts": [ { "id": "availability-evidence-evidence", "name": "Availability and shortage assertions evidence index", "description": "Local index of attributed references and review outcomes for availability and shortage assertions. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-004", "SRC-010" ] } ], "inline_only_rationale": null } ] }, { "id": "vigilance", "name": "Safety assessment references", "description": "A product can be linked to a concern spanning several products or substances. Preserve reported concern, assessment and published outcome as separate evidence states; a signal alone does not establish causality.", "source_refs": [ "SRC-009" ], "findings": [ { "id": "signal-context", "name": "Signals and assessment outcomes", "description": "A product can be linked to a concern spanning several products or substances. Preserve reported concern, assessment and published outcome as separate evidence states; a signal alone does not establish causality.", "source_refs": [ "SRC-009" ], "questions": [ { "id": "signal-context-q1", "text": "Which externally mastered signal or safety communication explicitly concerns this product, substance or product group?", "kind": "relationship", "answer_data": [ "signal-link", "Signal master reference, affected scope, issuer and linkage rationale" ] }, { "id": "signal-context-q2", "text": "Which assessment state and attributed outcome are reported, including uncertainty about causal association?", "kind": "state", "answer_data": [ "signal-assessment", "Assessment state, outcome reference, assessor role, time and uncertainty" ] }, { "id": "signal-context-q3", "text": "What minimum non-identifying product-level information can be exposed while individual case reports remain in restricted systems?", "kind": "privacy", "answer_data": [ "signal-disclosure", "Permitted summary fields, disclosure purpose, policy and restricted reference" ] } ], "data_elements": [ { "id": "signal-context-signal-link", "name": "signal-link", "description": "Signal master reference, affected scope, issuer and linkage rationale. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-009" ] }, { "id": "signal-context-signal-assessment", "name": "signal-assessment", "description": "Assessment state, outcome reference, assessor role, time and uncertainty. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-009" ] }, { "id": "signal-context-signal-disclosure", "name": "signal-disclosure", "description": "Permitted summary fields, disclosure purpose, policy and restricted reference. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-009" ] } ], "artifacts": [ { "id": "signal-context-evidence", "name": "Signals and assessment outcomes evidence index", "description": "Local index of attributed references and review outcomes for signals and assessment outcomes. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-009" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "continuity", "name": "Stewardship and record continuity", "description": "Govern local evidence records and transitions without claiming regulatory authority.", "rationale": "Proposed grouping of product-owned context; external master records remain referenced.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-007" ], "layers": [ { "id": "stewardship", "name": "Responsible roles", "description": "Applicant, authorization holder, manufacturer, regulator and local steward are distinct role references. A local owner cannot overwrite an authority decision or grant access to externally restricted records.", "source_refs": [ "SRC-001", "SRC-003" ], "findings": [ { "id": "role-attribution", "name": "Accountable role assignments", "description": "Applicant, authorization holder, manufacturer, regulator and local steward are distinct role references. A local owner cannot overwrite an authority decision or grant access to externally restricted records.", "source_refs": [ "SRC-001", "SRC-003" ], "questions": [ { "id": "role-attribution-q1", "text": "Which responsible party reference holds each product-specific role and for which effective period?", "kind": "ownership", "answer_data": [ "role-assignment", "Party master reference, role, territory, scope and effective period" ] }, { "id": "role-attribution-q2", "text": "What evidence authorizes the local steward to record or correct an assertion without changing its external legal effect?", "kind": "authority", "answer_data": [ "steward-mandate", "Mandate reference, delegated scope, reviewer role and validity" ] }, { "id": "role-attribution-q3", "text": "How is a holder transfer or source correction attributed while preserving previous responsibility and disputed evidence?", "kind": "provenance", "answer_data": [ "role-history", "Prior/new references, evidence, effective time, recorded time and correction reason" ] } ], "data_elements": [ { "id": "role-attribution-role-assignment", "name": "role-assignment", "description": "Party master reference, role, territory, scope and effective period. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003" ] }, { "id": "role-attribution-steward-mandate", "name": "steward-mandate", "description": "Mandate reference, delegated scope, reviewer role and validity. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "reference", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-001", "SRC-003" ] }, { "id": "role-attribution-role-history", "name": "role-history", "description": "Prior/new references, evidence, effective time, recorded time and correction reason. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003" ] } ], "artifacts": [ { "id": "role-attribution-evidence", "name": "Accountable role assignments evidence index", "description": "Local index of attributed references and review outcomes for accountable role assignments. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-001", "SRC-003" ] } ], "inline_only_rationale": null } ] }, { "id": "revision", "name": "Revision and retirement", "description": "Product identity, product-definition revision, terminology revision and legal status each retain their own history. Local retirement does not withdraw authorization or destroy a physical product.", "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ], "findings": [ { "id": "record-continuity", "name": "Versioned evidence continuity", "description": "Product identity, product-definition revision, terminology revision and legal status each retain their own history. Local retirement does not withdraw authorization or destroy a physical product.", "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ], "questions": [ { "id": "record-continuity-q1", "text": "Which change is a correction, revision, identity split, supersession or local retirement under the declared profile?", "kind": "lifecycle", "answer_data": [ "revision-decision", "Change type, profile, prior/new references, rationale and reviewer" ] }, { "id": "record-continuity-q2", "text": "Which retention rule and hold govern this record and its evidence, including lawful payload removal and minimal tombstones?", "kind": "retention", "answer_data": [ "retention-policy", "Policy reference, scope, retention trigger, legal hold and disposal authority" ] }, { "id": "record-continuity-q3", "text": "Which stale references, missing evidence or incompatible mappings block promotion of the local revision?", "kind": "validation", "answer_data": [ "validation-state", "Check results, unresolved references, profile version and approval state" ] } ], "data_elements": [ { "id": "record-continuity-revision-decision", "name": "revision-decision", "description": "Change type, profile, prior/new references, rationale and reviewer. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] }, { "id": "record-continuity-retention-policy", "name": "retention-policy", "description": "Policy reference, scope, retention trigger, legal hold and disposal authority. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "reference", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] }, { "id": "record-continuity-validation-state", "name": "validation-state", "description": "Check results, unresolved references, profile version and approval state. Candidate answer group; explicit unknown, disputed and not-applicable states require an adoption schema.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] } ], "artifacts": [ { "id": "record-continuity-evidence", "name": "Versioned evidence continuity evidence index", "description": "Local index of attributed references and review outcomes for versioned evidence continuity. Referenced evidence retains its original master identity and access policy.", "media_or_form": [ "structured evidence index", "human-readable review record" ], "serial": true, "identity_strategy": "Authoritative master-system identifier first; governed global IRI next; adopting Dimension UUID or ULID otherwise. Revision and sequence are separate from identity; dates and digests are not identity.", "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] } ], "inline_only_rationale": null } ] } ] } ] }, "functions": [ { "id": "register-definition", "name": "Register product definition", "description": "Proposed, unimplemented local operation. Create a provisional local definition from attributed evidence without asserting authorization.", "inputs": [ "Identity namespace and product scope", "Evidence index" ], "outputs": [ "Product reference or refusal with collision report" ], "preconditions": [ "Authorized role and permitted purpose verified", "Expected local revision matches; evidence scope and access checked", "Unknown or contradictory evidence is recorded and escalated, never silently resolved" ], "effects": [ "Append a provisional local definition; no external registration", "Write a local provenance entry; correction uses a new reviewed revision. External side effects require a separate authorized system." ], "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ] }, { "id": "record-presentation", "name": "Record declared presentation", "description": "Proposed, unimplemented local operation. Attach reviewed ingredient and form/strength evidence without calculating dose or preparation instructions.", "inputs": [ "Product revision", "Declared quantity and terminology references" ], "outputs": [ "New local revision or unresolved-unit report" ], "preconditions": [ "Authorized role and permitted purpose verified", "Expected local revision matches; evidence scope and access checked", "Unknown or contradictory evidence is recorded and escalated, never silently resolved" ], "effects": [ "Preserve source wording and basis; do not merge different presentations automatically", "Write a local provenance entry; correction uses a new reviewed revision. External side effects require a separate authorized system." ], "source_refs": [ "SRC-001", "SRC-002", "SRC-007" ] }, { "id": "attach-authorization", "name": "Attach regulatory assertion", "description": "Proposed, unimplemented local operation. Record an externally issued decision with territory, evidence state and effective time.", "inputs": [ "Decision reference", "Jurisdiction and effective period" ], "outputs": [ "Attributed assertion or conflicting-evidence report" ], "preconditions": [ "Authorized role and permitted purpose verified", "Expected local revision matches; evidence scope and access checked", "Unknown or contradictory evidence is recorded and escalated, never silently resolved" ], "effects": [ "Append evidence history; no authorization grant, suspension or withdrawal", "Write a local provenance entry; correction uses a new reviewed revision. External side effects require a separate authorized system." ], "source_refs": [ "SRC-003", "SRC-004" ] }, { "id": "link-monitoring", "name": "Link monitoring evidence", "description": "Proposed, unimplemented local operation. Attach a scoped quality, shortage or signal notice without deciding causality, authenticity or substitutability.", "inputs": [ "Notice reference", "Product/presentation match and scope" ], "outputs": [ "Scoped link or unresolved-match result" ], "preconditions": [ "Authorized role and permitted purpose verified", "Expected local revision matches; evidence scope and access checked", "Unknown or contradictory evidence is recorded and escalated, never silently resolved" ], "effects": [ "Record observed state only; no recall, patient action or repository transaction", "Write a local provenance entry; correction uses a new reviewed revision. External side effects require a separate authorized system." ], "source_refs": [ "SRC-008", "SRC-009", "SRC-010" ] }, { "id": "review-mapping", "name": "Review terminology mapping", "description": "Proposed, unimplemented local operation. Record a human-reviewed semantic mapping with releases and losses.", "inputs": [ "Source and target concept versions", "Relation and reviewer rationale" ], "outputs": [ "Qualified mapping or ambiguity report" ], "preconditions": [ "Authorized role and permitted purpose verified", "Expected local revision matches; evidence scope and access checked", "Unknown or contradictory evidence is recorded and escalated, never silently resolved" ], "effects": [ "Append mapping revision; no clinical equivalence inference", "Write a local provenance entry; correction uses a new reviewed revision. External side effects require a separate authorized system." ], "source_refs": [ "SRC-005", "SRC-006", "SRC-007" ] }, { "id": "retire-record", "name": "Retire local product record", "description": "Proposed, unimplemented local operation. Retire or supersede a local record according to the adopting retention policy.", "inputs": [ "Revision reference", "Supersession and retention decision" ], "outputs": [ "Retirement marker or hold refusal" ], "preconditions": [ "Authorized role and permitted purpose verified", "Expected local revision matches; evidence scope and access checked", "Unknown or contradictory evidence is recorded and escalated, never silently resolved" ], "effects": [ "Keep lawful resolvable history and delegate approved payload disposal; no physical destruction or legal status change", "Write a local provenance entry; correction uses a new reviewed revision. External side effects require a separate authorized system." ], "source_refs": [ "SRC-001", "SRC-002" ] } ], "composition": [ { "target": "WM-MAT-001", "relation": "REFERENCE", "purpose": "Candidate substance binding; chemical identity and lifecycle remain external. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-001", "SRC-002" ] }, { "target": "WM-OBJ-001", "relation": "REFERENCE", "purpose": "Candidate individual pack binding; physical state and custody remain external. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-002", "SRC-008" ] }, { "target": "WM-MAT-004", "relation": "REFERENCE", "purpose": "Candidate lot binding; release, expiry and lot lifecycle remain external. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-008" ] }, { "target": "WM-OBJ-002", "relation": "ALIGN", "purpose": "Candidate product-type alignment; inheritance requires a pinned compatible contract. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-002" ] }, { "target": "WM-OBJ-003", "relation": "REFERENCE", "purpose": "Optional commercial offer context; no inherited market eligibility or offer lifecycle. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-002", "SRC-004" ] }, { "target": "WM-ACT-048", "relation": "REFERENCE", "purpose": "Candidate clinical-record link; clinical authority and actions remain external. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-002", "SRC-006" ] }, { "target": "HL7 FHIR R5 MedicinalProductDefinition", "relation": "ALIGN", "purpose": "Conceptual alignment only; nested resources and executable mappings are deferred. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-002" ] }, { "target": "ISO IDMP via EMA overview", "relation": "ALIGN", "purpose": "Conceptual alignment only; licensed normative editions and implementation profile must be reviewed. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-001" ] }, { "target": "ATC/DDD and RxNorm", "relation": "ALIGN", "purpose": "Versioned class and concept mappings, never product identity or substitution guarantees. Resolve exact target version before operational use.", "required": false, "source_refs": [ "SRC-005", "SRC-006", "SRC-007" ] } ], "serviceLayers": { "dimension": { "owner_package_requirements": [ "Designate a local product-data steward role and a qualified regulatory reviewer role; use party references, not brand owners", "Declare jurisdiction, human-use scope, authoritative sources, identity granularity and profile version", "Declare evidence licensing, privacy, retention, access and legal-hold policies before population", "Pin external model and vocabulary versions and document unresolved mappings" ], "namespace_guidance": "Use an adopting-Dimension namespace for local IDs. Preserve external namespace, code and version; never mint authority identifiers or rewrite source identifiers.", "registry_links": [ "vr.wm-obj-005", "Candidate neighbor references are listed in composition; no mandatory runtime binding is claimed" ] }, "canon_and_patch": { "canonicalization_rules": [ "Normalize whitespace and code representation only with a loss record; retain original names, units, languages and source assertions", "Keep ingredient basis, manufactured/administrable state, strength denominator and package granularity distinct", "Record local revision, source revision, effective time and observation time separately" ], "patch_rules": [ "Require expected revision, role authorization, reason and evidence for each local patch", "Never overwrite a conflicting authority statement; record both and route to qualified review" ], "compatibility_rules": [ "A changed definition may require a new identity according to the adopting profile; maintain explicit supersession", "Unpinned vocabularies or lossy mappings block operational conformance claims" ] }, "artifact_rules": { "identity_priority": [ "Authoritative master-system identifier with namespace", "Governed global identifier or IRI", "UUID or ULID assigned by the adopting Dimension" ], "timestamp_rule": "Instants use RFC 3339 with seconds and explicit offset or Z. Keep event/effective time distinct from observation and ingestion time. Preserve date-only precision for legal dates and expiry; never invent an instant.", "serial_naming_rule": "Use stable master identifier and separate revision/sequence metadata. Dates are display metadata, never the identity key.", "integrity_rule": "Hash retained evidence bytes and record origin, retrieval method, revision, access policy and license. A digest detects change but does not prove truth or authenticity." }, "policies": [ "Research assurance remains reviewable-draft under a single-provider waiver. Missing evidence cannot be converted into a positive safety or approval claim.", "Keep controlled-status content at policy level; prohibit synthesis, extraction, diversion, unauthorized acquisition and operational handling instructions.", "Do not recommend individual treatment, dose or substitution; clinical action belongs to qualified clinical systems.", "Minimize personal and confidential data; keep individual safety reports external and restricted. Access to a public page does not license all derived datasets." ], "crud": { "read": [ "Resolve the permitted audience and purpose, source freshness and product scope before exposing assertions" ], "create": [ "Create only an attributed provisional definition after identity collision checks; lack of authorization is not an identity failure" ], "update": [ "Use reviewed append-only revision metadata with expected-version checks; lawful payload removal is governed separately" ], "delete": [ "Local retirement preserves only the history allowed by the retention policy. The adopting Dimension retention service owns approved payload deletion, legal holds and minimal non-sensitive tombstones.", "Deleting a local record never deletes a referenced pack, regulator decision or safety case, and never withdraws market authorization." ] }, "roles": [ { "name": "Product data steward", "responsibilities": [ "Maintains local identity and evidence links within delegated scope" ] }, { "name": "Regulatory reviewer", "responsibilities": [ "Reviews jurisdiction, decision provenance and profile applicability" ] }, { "name": "Quality reviewer", "responsibilities": [ "Reviews batch or pack notice applicability in an external quality system" ] }, { "name": "Vigilance reviewer", "responsibilities": [ "Reviews product-level safety communication links without importing personal case files" ] }, { "name": "Access and retention custodian", "responsibilities": [ "Applies purpose-based disclosure, legal holds and lawful disposal" ] }, { "name": "Read-only consumer", "responsibilities": [ "Uses approved views and preserves uncertainty and source limits" ] } ], "access": { "default_rule": "Deny access to confidential evidence by default; expose only explicitly approved public product summaries. Local ownership never overrides source restrictions.", "scopes": [ "bundle", "layer", "finding", "artifact" ], "exceptions": [ "Public product-information references can be shared under their terms; restricted safety and serialization details require a scoped mandate", "Emergency or statutory access requires an evidenced external policy decision and audit record" ], "audit_requirements": [ "Record actor role, purpose, product revision, source references, access decision and timestamp for reads and changes", "Audit storage is externally governed; avoid copying confidential payloads into access logs" ] }, "agents_bootstrap": { "filename": "AGENTS.md", "required_fields": [ "Name", "Type", "Specification URL", "Storage type URL", "Interface URL", "Processes URL" ], "read_order": [ "AGENTS.md", "spec.yaml and publication holds", "Adopting Dimension owner, access and retention policy", "Pinned external model contracts and evidence revisions" ] } }, "coverage": { "claim": "Source-grounded proposed structure for a persistent human medicinal product definition, using selected EU and US evidence. Separate local no-tools self-audit completed. Independent review, source/version verification, jurisdiction profiles and executable conformance remain holds; this is a noncanonical reviewable draft.", "confidence": "medium", "checklist": [ { "dimension": "identity", "status": "covered", "notes": "Scoped product definition identifiers; no name-only merges" }, { "dimension": "lifecycle", "status": "covered", "notes": "Product revision and legal status separated" }, { "dimension": "relationships", "status": "covered", "notes": "Substance, pack, batch and clinical masters remain external" }, { "dimension": "temporal", "status": "covered", "notes": "Effective and observed time, precision and stale evidence" }, { "dimension": "provenance", "status": "covered", "notes": "Attribution and document revision on assertions" }, { "dimension": "ownership", "status": "covered", "notes": "Role references distinguish steward, holder and regulator" }, { "dimension": "validation", "status": "gap", "notes": "Research schema validatable; nested instance schemas and fixtures deferred" }, { "dimension": "access", "status": "covered", "notes": "Public projections and restricted evidence separated" }, { "dimension": "retention and deletion", "status": "covered", "notes": "Adopting retention service, holds and minimal tombstones" }, { "dimension": "interoperability", "status": "gap", "notes": "Conceptual alignments only; normative editions and executable mappings unverified" }, { "dimension": "direct properties", "status": "covered", "notes": "Declared composition, form and strength with units and basis" }, { "dimension": "recognition and observation", "status": "covered", "notes": "Label/code observations do not establish authenticity" }, { "dimension": "capabilities and actions", "status": "covered", "notes": "Local evidence operations only; no clinical or regulatory execution" }, { "dimension": "context and evidence", "status": "covered", "notes": "Market, legal profile, quality and safety reference context" }, { "dimension": "specialized profiles", "status": "gap", "notes": "Veterinary, advanced therapy, radiopharmaceutical and special preparation profiles deferred" } ], "known_omissions": [ "Independent second-provider review is absent; a separate local no-tools self-audit is required", "Direct HTTP and current source/version verification remain open; web content retrieval is not measured HTTP verification", "Nested instance schemas, code releases, identifier binding, units and adversarial conformance fixtures are not implemented", "Jurisdiction-specific legal pathways, controlled schedules and veterinary or specialized product profiles require qualified review", "No patient safety, therapeutic equivalence, authenticity, manufacturing quality or availability certification" ], "conflicts": [], "regional_assumptions": [ "Human medicinal product focus; EU legal examples and US terminology/listing examples are not universal rules", "Directive consolidation dated 2025-01-01 reviewed selectively; later changes, national transposition and applicability remain open", "Original safety-features regulation reviewed selectively; current amendments and exceptions must be reconciled" ], "adversarial_checks": [ "Challenge ATC or NDC reuse as authorization or unique regulated product identity", "Challenge strength/form merges and confusion of manufactured versus administrable presentation", "Challenge barcode recognition as authenticity, batch release or absence of recall", "Challenge safety signal as causality and shortage alternatives as treatment substitution", "Challenge legacy generic-good inheritance after M3 successor changed to an offer view" ] }, "researchAdjudication": { "providerMode": "single-provider-waiver", "activeProviders": [ "codex" ], "waivedProviders": [ "claude", "grok" ], "providerPolicy": { "contract_version": "1.0.0", "mode": "single-provider-waiver", "effective_at": "2026-09-06T00:00:00Z", "scope": "Canonical single-stream subject-model research after the six-workstream consolidation", "active_providers": [ "codex" ], "waived_providers": [ { "provider": "claude", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "Claude produced no result on prior 1800-second and 900-second attempts and again timed out on bounded 600-second Sonnet and 300-second Haiku passes. The owner prioritized completion over provider availability." }, { "provider": "grok", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "The repository owner authorized completion without Grok when Grok is unavailable, slow or schema-invalid. Grok may still be attempted as a bounded supplemental reviewer, but its failure never blocks a valid Claude plus no-tools result." } ], "review_rule": "Codex may complete source-grounded fallback research after bounded Claude and Grok attempts fail. It requires a separate no-tools adversarial audit and remains reviewable-draft with a visible absence-of-external-review hold.", "supplemental_provider_attempts": [ { "provider": "claude", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." }, { "provider": "grok", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." } ] }, "boundaryDecision": { "entry_kind": "entity", "status": "accepted", "rationale": "The root is a persistent product definition, with revisions and external evidence links. It is distinct from a substance, batch, pack, authorization event or patient medication record. The registry standalone-mm value describes the record plane, not the subject-kind enum. Human-use coverage is explicit; specialized and veterinary profiles remain gaps." }, "decisions": [ { "concept": "Product identity granularity", "disposition": "accepted with profile qualification", "rationale": "Names and identifiers retain namespace and scope. Formulation or strength differences cannot be merged solely by name; exact identity-change rules remain an adoption requirement." }, { "concept": "Legacy controlled-substance root", "disposition": "narrowed", "rationale": "Non-product substances are excluded. Controlled status remains a jurisdictional policy reference, with no preparation, acquisition or handling operations." }, { "concept": "Classification and listing claims", "disposition": "separated", "rationale": "ATC classification, RxNorm concepts, NDC listing and authorization have distinct semantics. DDD is explicitly prevented from becoming patient dosing advice." }, { "concept": "Composition and presentation", "disposition": "accepted", "rationale": "The finding questions preserve ingredient role, basis substance, numerator, denominator and manufactured or administrable state. Unknown declarations remain explicit, and chemistry stays external." }, { "concept": "Authorization maximum and lifecycle", "disposition": "legacy maximum rejected", "rationale": "The draft does not impose one active authorization per jurisdiction. It records decision scope, effective time and conflict evidence independently from marketing availability and local record status." }, { "concept": "Clinical and storage information", "disposition": "accepted as evidence context", "rationale": "Document references and declared storage constraints do not authorize treatment or excuse a measured storage excursion. Observation and quality disposition remain external references." }, { "concept": "Pack recognition and batch verification", "disposition": "legacy guarantee rejected", "rationale": "Appearance, code observation, external verification response, batch release and recall evidence are distinct. Unknown or stale checks cannot produce an all-clear or authenticity guarantee." }, { "concept": "Shortage and safety assessment", "disposition": "accepted with uncertainty", "rationale": "Market-specific shortage assertions do not establish stock or substitutability. A signal retains assessment state and cannot be promoted to causal proof; personal case reports remain restricted." }, { "concept": "Legacy M3 and neighbor bindings", "disposition": "qualified", "rationale": "The legacy generic-good extension is not inherited from its offer-view successor. Product-type alignment and substance, lot, pack and clinical links are optional candidates requiring pinned contracts." }, { "concept": "Ownership and local operations", "disposition": "accepted as proposed only", "rationale": "Holder, manufacturer, regulator and steward roles are separated. All six functions require role and revision checks and affect local records only; no clinical, regulatory or physical side effect is authorized." }, { "concept": "Artifacts, privacy and retention", "disposition": "accepted with adoption dependency", "rationale": "Evidence indices have stable identities separate from dates and digests. Access remains purpose-scoped, and revision continuity is qualified by lawful payload removal, holds and minimal tombstones." }, { "concept": "Source assurance and conformance", "disposition": "held", "rationale": "Ten official pages support a research design, not normative implementation or legal currency. Direct HTTP was unattempted under the reported sandbox restriction. Candidate answer groups are not executable instance schemas." }, { "concept": "Independent review", "disposition": "waived and held", "rationale": "This separate phase is a local Codex self-audit of frozen evidence. Claude and Grok were skipped; neither independent external review nor provider agreement can be claimed." } ], "publicationHolds": [ "Independent external review is absent under the owner-authorized single-provider waiver. Claude and Grok were skipped with zero attempts; the local no-tools self-audit is not a second-provider review.", "Source and version verification is incomplete. Ten official pages were retrieved through the web tool, but direct HTTP was not attempted under the owner-reported sandbox block: zero HTTP statuses measured. Run check_sources.py outside the sandbox; HTTP success alone cannot close substantive or current-version verification.", "Jurisdiction, legal pathway, national transposition, current controlled-status rules, specialized product profiles, terminology licensing and clinical applicability require qualified adoption review. No treatment, authenticity, product quality or legal-compliance certification is claimed.", "Nested instance schemas, exact neighbor versions, vocabulary releases, units, ISO IDMP and FHIR mappings, executable functions and adversarial conformance fixtures are not implemented. Candidate answer groups require an adopting profile before operational use.", "Independent external review was explicitly waived by the repository owner; this codex-only result remains a reviewable draft." ], "deferredResearch": [ "Reconcile current legal amendments, national applicability, safety-feature exceptions and authoritative source revisions for each adopting jurisdiction.", "Develop and test nested schemas and pinned mappings using cases with multiple strengths, ambiguous ingredient basis, conflicting authorizations, stale pack checks and uncertain safety or shortage scope.", "Expand specialized and veterinary profiles only with separate primary evidence and qualified review; restore independent second-provider review before canonical promotion." ] }, "statistics": { "sources": 10, "bundles": 7, "layers": 14, "findings": 14, "questions": 42, "artifacts": 14, "functions": 6 } }