Published

Medicinal Product

vr.wm-obj-005 · wm-obj-005-medicinal-product

Maintain a governed medicinal product definition with attributable composition, presentation, regulatory context and links to safety and supply evidence.

World Models Physical world and living systems PHY.OBJ.DRUG

Bundle → Layer → Finding → Questions Classifiers What it is Why it exists Distinguishing features What robots and AI may and may not do Moral aspects Owners Links to other meta-models Identity and identifiers Direct properties Recognition Capabilities and actions Hazards and failure modes Standards and interfaces Context of use Sources

Bundle → Layer → Finding → Questions Filled

7 bundles · 14 layers · 14 findings · 42 questions

Product identity Recognize one regulated product definition without collapsing names, classes or physical instances.

Names and identifiers

Proposed context for a persistent product definition and its revisions. Identity granularity is set by an adopting profile; names alone cannot merge records.

Scoped product identity

Proposed context for a persistent product definition and its revisions. Identity granularity is set by an adopting profile; names alone cannot merge records.

Which authoritative product identifier and namespace distinguish this definition from a substance, package type and individual pack? identity
Which human-use product scope and development or regulatory category apply to this record? classification
Which official name variants, languages and evidence revisions support identification without relying on appearance alone? provenance

Terminology alignment

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.

Qualified terminology mappings

What mapping relation and version connect this product to an ATC, RxNorm or other external concept? interoperability
Which ambiguity or change in strength, form or ingredient prevents automatic equivalence or identity merging? validation
How is any DDD annotation marked as a utilization metric so it cannot become patient dosing advice? constraint

Composition and presentation Describe declared product properties with explicit substance and quantity context.

Ingredient declarations

References identify active ingredients and relevant excipients. The product owns their declared role and formulation context, while chemical identity and hazards remain substance-owned.

Substances and ingredient roles

References identify active ingredients and relevant excipients. The product owns their declared role and formulation context, while chemical identity and hazards remain substance-owned.

Which substance reference and role are declared for each ingredient in this product revision? composition
Which excipient or ingredient declaration is incomplete, disputed or outside the evidence coverage? quality
How are combination-product components kept distinct without importing their chemical or device lifecycle? relationship

Strength, form and route

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.

Declared presentation properties

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.

What strength expression, basis substance and denominator apply before or after any declared transformation? measurement
Which manufactured form, administrable form, unit of presentation and route are declared with terminology versions? classification
Which presentation changes require a new product identity versus a revision under the adopting authority profile? exception

Regulatory context Attach authoritative decisions and scoped restrictions without executing legal or clinical actions.

Authorization standing

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.

Market authorization assertions

Which decision, issuing authority and legal pathway support the stated authorization status for this product and territory? authority
When did each authorization assertion take effect and when was its evidence observed? temporal
How are pending, refused, suspended, withdrawn, unknown and conflicting authorization assertions kept separate from marketing availability? state

Prescription and controlled status

Policy-only references describe prescription and controlled status where applicable. No schedule lookup table, acquisition instructions or operational handling procedures are supplied.

Jurisdictional policy restrictions

Policy-only references describe prescription and controlled status where applicable. No schedule lookup table, acquisition instructions or operational handling procedures are supplied.

Which jurisdiction-specific prescription or controlled-status decision applies to this formulation and presentation? constraint
What effective period and reviewed legal version govern each restriction assertion? temporal
What unresolved exemption, cross-border difference or applicability question requires qualified review before use? exception

Product information Preserve attributable product information and its use limits.

Clinical particulars references

Index approved or proposed product information by evidence state. Clinical particulars are document references, not a patient-specific recommendation or an assessment of suitability.

Indications and safety information

Index approved or proposed product information by evidence state. Clinical particulars are document references, not a patient-specific recommendation or an assessment of suitability.

Which product-information revision supplies indications, contraindications, warnings and interaction references for this market? evidence
Is that product information approved, proposed, superseded or unverified, and what evidence supports that state? state
Which public or restricted view may expose the document without leaking patient reports or confidential assessment material? access

Storage and shelf-life declarations

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.

Labeled storage constraints

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.

Which approved storage and shelf-life declaration applies to the sealed or opened presentation? requirement
What method, conditions, time, units and uncertainty accompany any linked observation relevant to a storage concern? measurement
Who must assess an excursion or shelf-life ambiguity in the external quality system before any disposition is recorded? decision

Packaging and traceability references Connect product definitions to separately mastered pack and quality evidence.

Package definitions and recognition

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.

Package variants and identification evidence

Which package definition, contents and presentation identifiers link to this product revision? composition
What label or code observation supports a tentative product match and what mismatch remains? evidence
Which authorized external verification result and scope support a pack-status assertion without equating it with batch release? validation

Batch and recall links

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.

Batch and recall applicability

Which external batch or pack references are covered by an attributed quality or recall notice? relationship
When was the notice effective, revised or withdrawn and when was its applicability last checked? temporal
How is uncertain scope, contradictory release evidence or a failed verification response represented pending quality review? exception

Market and safety monitoring Attach market-specific observations and assessed safety evidence.

Market availability

Represent dated availability and shortage notices with their reporting coverage. Authorization, marketing status, shortage status and local inventory are different assertions.

Availability and shortage assertions

Represent dated availability and shortage notices with their reporting coverage. Authorization, marketing status, shortage status and local inventory are different assertions.

Which territory, presentation and reporting population are covered by an availability or shortage notice? spatial
What observation interval, anticipated dates and update time qualify the notice? temporal
What prevents an absent shortage entry or a listed alternative from being read as available stock or therapeutic substitutability? constraint

Safety assessment references

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.

Signals and assessment outcomes

Which externally mastered signal or safety communication explicitly concerns this product, substance or product group? relationship
Which assessment state and attributed outcome are reported, including uncertainty about causal association? state
What minimum non-identifying product-level information can be exposed while individual case reports remain in restricted systems? privacy

Stewardship and record continuity Govern local evidence records and transitions without claiming regulatory authority.

Responsible roles

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.

Accountable role assignments

Which responsible party reference holds each product-specific role and for which effective period? ownership
What evidence authorizes the local steward to record or correct an assertion without changing its external legal effect? authority
How is a holder transfer or source correction attributed while preserving previous responsibility and disputed evidence? provenance

Revision and retirement

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.

Versioned evidence continuity

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.

Which change is a correction, revision, identity split, supersession or local retirement under the declared profile? lifecycle
Which retention rule and hold govern this record and its evidence, including lawful payload removal and minimal tombstones? retention
Which stale references, missing evidence or incompatible mappings block promotion of the local revision? validation

Classifiers Filled

Family: World Models
Category: Physical world and living systems
Entry kind: entity
Navigation path: NAV.PHY.OBJ.DRUG
Domain: PHY.OBJ.DRUG
Industry: Cross-industry
Tags: medicinalproductphy.obj.drug
Also called: M5

What it is Filled

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

Why it exists Filled

Maintain a governed medicinal product definition with attributable composition, presentation, regulatory context and links to safety and supply evidence.

Distinguishing features Derived, awaiting review

Unlike Legacy M5: 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.
Unlike WM-MAT-001 Chemical Substance: Reference substance identity and external hazard evidence; retain only product-specific role and declared quantity context.
Unlike WM-OBJ-001 Physical Item Instance and WM-MAT-004 Material Batch / Lot: Individual packs and production lots remain separate masters; product definition references their evidence without owning physical lifecycle.
Unlike WM-OBJ-002 Product Type / Catalog Item and WM-OBJ-003 Tradable Offer / Commodity view: 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.
Unlike WM-ACT-048 Medication Order / Administration: Medication orders, dispensing and administration retain clinical identity and authority. A product reference supplies context only.
Unlike Authorization, quality, vigilance and shortage source records: 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.

Note: Derived from boundary notes against neighbouring models.

What robots and AI may and may not do Derived, awaiting review

Must not

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.
Deleting a local record never deletes a referenced pack, regulator decision or safety case, and never withdraws market authorization.
Deny access to confidential evidence by default; expose only explicitly approved public product summaries.
Local ownership never overrides source restrictions.

May

Register product definition: Proposed, unimplemented local operation. Create a provisional local definition from attributed evidence without asserting authorization.
Record declared presentation: Proposed, unimplemented local operation. Attach reviewed ingredient and form/strength evidence without calculating dose or preparation instructions.
Attach regulatory assertion: Proposed, unimplemented local operation. Record an externally issued decision with territory, evidence state and effective time.
Link monitoring evidence: Proposed, unimplemented local operation. Attach a scoped quality, shortage or signal notice without deciding causality, authenticity or substitutability.
Review terminology mapping: Proposed, unimplemented local operation. Record a human-reviewed semantic mapping with releases and losses.
Retire local product record: Proposed, unimplemented local operation. Retire or supersede a local record according to the adopting retention policy.

Note: Derived from functions, policies, CRUD and access rules; prohibitions were not authored for agents as such.

Moral aspects Derived, awaiting review

Declare evidence licensing, privacy, retention, access and legal-hold policies before population
Local revision, evidence quality, privacy, access and retirement rules

Note: Sentences mentioning harm, privacy, consent or similar, collected from the specification.

Owners Filled

Steward

Designate a local product-data steward role and a qualified regulatory reviewer role; use party references, not brand owners

Roles

Product data steward: Maintains local identity and evidence links within delegated scope
Regulatory reviewer: Reviews jurisdiction, decision provenance and profile applicability
Quality reviewer: Reviews batch or pack notice applicability in an external quality system
Vigilance reviewer: Reviews product-level safety communication links without importing personal case files
Access and retention custodian: Applies purpose-based disclosure, legal holds and lawful disposal
Read-only consumer: Uses approved views and preserves uncertainty and source limits

Links to other meta-models Filled

references

WM-MAT-001 - Candidate substance binding; chemical identity and lifecycle remain external. Resolve exact target version before operational use.
WM-OBJ-001 - Candidate individual pack binding; physical state and custody remain external. Resolve exact target version before operational use.
WM-MAT-004 - Candidate lot binding; release, expiry and lot lifecycle remain external. Resolve exact target version before operational use.
WM-OBJ-003 - Optional commercial offer context; no inherited market eligibility or offer lifecycle. Resolve exact target version before operational use.
WM-ACT-048 - Candidate clinical-record link; clinical authority and actions remain external. Resolve exact target version before operational use.

aligned

WM-OBJ-002 - Candidate product-type alignment; inheritance requires a pinned compatible contract. Resolve exact target version before operational use.
HL7 FHIR R5 MedicinalProductDefinition - Conceptual alignment only; nested resources and executable mappings are deferred. Resolve exact target version before operational use.
ISO IDMP via EMA overview - Conceptual alignment only; licensed normative editions and implementation profile must be reviewed. Resolve exact target version before operational use.
ATC/DDD and RxNorm - Versioned class and concept mappings, never product identity or substitution guarantees. Resolve exact target version before operational use.

neighbor

Legacy M5 - 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.
WM-MAT-001 Chemical Substance - Reference substance identity and external hazard evidence; retain only product-specific role and declared quantity context.
WM-OBJ-001 Physical Item Instance and WM-MAT-004 Material Batch / Lot - Individual packs and production lots remain separate masters; product definition references their evidence without owning physical lifecycle.
WM-OBJ-002 Product Type / Catalog Item and WM-OBJ-003 Tradable Offer / Commodity view - 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.
WM-ACT-048 Medication Order / Administration - Medication orders, dispensing and administration retain clinical identity and authority. A product reference supplies context only.
Authorization, quality, vigilance and shortage source records - 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.

What else AI and robots need to interact with it Incomplete

Sources Filled

Data on medicines (ISO IDMP standards): Overview - European Medicines Agency
MedicinalProductDefinition - FHIR v5.0.0 - HL7 International
Directive 2001/83/EC - consolidated text - European Parliament and Council
National Drug Code Directory - United States Food and Drug Administration
Anatomical Therapeutic Chemical (ATC) Classification - World Health Organization
Defined Daily Dose (DDD) - World Health Organization
RxNorm Overview - United States National Library of Medicine
Commission Delegated Regulation (EU) 2016/161 - European Commission
Signal management - European Medicines Agency
Public information on medicine shortages - European Medicines Agency

Open questions

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.
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

Machine files

Card as JSON Specification AGENTS.md Source Card backlog vercy.card/1

Provenance

world-models research · reviewable-draft

Built from: models/wm-obj-005-medicinal-product/spec.yaml