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Medicine & Health Substance

This meta-model describes medicinal products and controlled substances: what a medicine contains and in what form and strength, under which authorizations and schedules it may circulate, how its batches move, and what safety signals surround it. It is its own model because medicines combine market goods semantics with a dense regulatory and vigilance apparatus (authorizations, controlled status, batch verification, signals) that no other goods category carries.

AI YAMLAGENTS.mdSource
IDworld.m5-medicine-and-health-substance
Version history0.2.0-legacy
CategoryReference example
IndustryCross-industry
Domainmatter-artifacts
Tagsmedicine, health, substance
Data structure

Bundles and layers

Bundle

product

What the medicine is

Layers

medicineIdentity`: product name, classification codes, holder reference · `activeComposition`: active substances with roles and reference strengths · `formAndStrength`: dose forms, strengths, routes of administration

Bundle

authorization

Under what permissions it circulates

Layers

marketingAuthorization`: authorizations per jurisdiction with status and conditions · `controlledStatus`: scheduling of the product or its substances per jurisdiction

Bundle

supply

How physical product reaches use

Layers

batchAndSerialization`: batches, expiry, pack serialization ranges · `supplyStatus`: availability and shortage standing per market

Bundle

vigilance

What safety knowledge surrounds it

Layers

safetySignal`: signals, their sources, assessment state and outcomes

Findings

Catalogue-native findings must describe the information grouped by each layer. This legacy version does not declare them separately.

Questions & artifacts

Questions, artifact requirements and serial naming rules are required by Vercy vNext; they remain unassigned in this reference version.

Service layers

How this specification operates

Dimension & namespace

  • EXTEND `world.tradableGood` (M3): a medicine is a good; identifiers, packaging and batch mechanics are inherited, regulatory and vigilance semantics are added.
  • REFERENCE `world.materialSubstance` (M1): active substances and excipients resolve to substance classes with their hazard data.
  • REFERENCE `world.physicalItem` (M2): a serialized pack under verification is an individual item.
  • REFERENCE the health cluster (H): indications, contraindications and adverse effect terms resolve to health-cluster condition semantics rather than local text.
  • imports: who-atc (REFERENCE): anatomical-therapeutic-chemical classification codes.
  • imports: rxnorm (ALIGN): clinical drug naming alignment.
  • imports: iso-idmp (ALIGN): identification-of-medicinal-products concepts for product, form and strength.

Canon, patches & standards

  • EXTEND `world.tradableGood` (M3): a medicine is a good; identifiers, packaging and batch mechanics are inherited, regulatory and vigilance semantics are added.
  • REFERENCE `world.materialSubstance` (M1): active substances and excipients resolve to substance classes with their hazard data.
  • REFERENCE `world.physicalItem` (M2): a serialized pack under verification is an individual item.
  • REFERENCE the health cluster (H): indications, contraindications and adverse effect terms resolve to health-cluster condition semantics rather than local text.
  • imports: who-atc (REFERENCE): anatomical-therapeutic-chemical classification codes.
  • imports: rxnorm (ALIGN): clinical drug naming alignment.
  • imports: iso-idmp (ALIGN): identification-of-medicinal-products concepts for product, form and strength.

Artifact formats & serial data

Format-independent core. Concrete artifact formats and naming prefixes are not declared in this legacy version.

Policies & accepted processes

  • `registerAccess`: read access to identity, form, strength and authorization status, typically broad for public registers.
  • `batchVerification`: query contract confirming that a serialized pack belongs to a genuine, released, non-recalled batch.
  • `vigilanceExchange`: structured exchange of safety signals and their assessments between the holder and oversight parties.

Read / add / edit / delete

CRUD procedures and interface bindings are not declared in this legacy version.

Ownership, roles & access

Product records are stewarded by the producer holding the marketing authorization, while authorization, scheduling and vigilance layers are overseen by a public health authority archetype; in both cases access by any other party is granted by the record owner through S1/S2, and all regulatory events are traceable via S4 audit.

Existing assembly

Objects, relationships, events and projections

Objects

  • `medicine`: a medicinal product class; key attributes: name, classification codes, authorization holder reference.
  • `activeSubstanceLink`: the tie from a medicine to an active substance; key attributes: substance reference, role, reference strength.
  • `doseFormSpec`: a dose form the medicine is presented as; key attributes: form, route of administration, appearance.
  • `strengthSpec`: a strength presentation; key attributes: amount, unit, per-unit basis.
  • `marketingAuthorization`: permission to market in a jurisdiction; key attributes: jurisdiction, number, status, conditions, validity.
  • `controlledStatus`: scheduling of the product or substance; key attributes: jurisdiction, schedule, restrictions.
  • `medicineBatch`: a production batch; key attributes: batch code, expiry date, serialization range, release status.
  • `safetySignal`: a detected or reported safety concern; key attributes: source, description, assessment state, outcome.

Relationships

  • `medicine` -> contains -> `activeSubstanceLink` (1..*): every medicine declares at least one active substance.
  • `medicine` -> presentedAs -> `doseFormSpec` (1..*): forms the product exists in.
  • `medicine` -> dosedAt -> `strengthSpec` (1..*): strengths per form.
  • `medicine` -> authorizedUnder -> `marketingAuthorization` (0..*): one authorization per jurisdiction at most is active.
  • `medicine` -> scheduledUnder -> `controlledStatus` (0..*): controlled standing varies by jurisdiction.
  • `medicineBatch` -> ofMedicine -> `medicine` (many-to-one): batches bound production populations.
  • `safetySignal` -> concerns -> `medicine` (many-to-many): one signal can span products sharing a substance.

Events

  • `authorizationGranted`: a marketing authorization was issued in a jurisdiction.
  • `authorizationVaried`: the terms or conditions of an authorization changed.
  • `authorizationSuspended`: an authorization was suspended or revoked.
  • `batchReleased`: a batch passed release and entered the supply chain.
  • `batchRecalled`: a batch was recalled with a stated classification and scope.
  • `scheduleChanged`: the controlled status of the product changed in a jurisdiction.
  • `safetySignalRaised`: a new safety signal entered assessment.
  • `shortageDeclared`: availability of the product fell below demand in a market.

Projections

  • `publicRegisterView`: name, composition, form, strength and authorization status; omits supply chain and serialization detail.
  • `prescriberView`: forms, strengths, controlled status and active signals relevant to prescribing; omits batch logistics.
  • `supplyChainView`: batches, expiry, serialization and shortage standing; omits vigilance assessment internals.