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15.1 Resource MedicinalProductDefinition - Content

Biomedical Research and Regulation icon Work GroupMaturity Level: 3 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).



For an overview of this resource and others in the Medication Definition domain, also see the module page

The MedicinalProductDefinition resource covers the detailed defining data of medicinal products, to a level beyond what is typically needed for day to day prescribing, but that is commonly required by manufacturers and regulators, and also for use in drug catalogs and pharmacopoeias. (For direct patient care when prescribing the correct resource is Medication).

This product resource is associated with others that describe the packaging, the actual medication in its manufactured form (e.g. the tablet itself), its ingredients, and the substances within. These products are generally regulated by national or regional bodies or agencies. See note below about the RegulatedAuthorization resource.

The administrable (or "pharmaceutical") product - which differs in that it is now "mixed" from its components (if necessary) and is ready for use - is covered by the AdministrableProductDefinition resource.

This MedicinalProductDefinition resource is the one that represents the product as a whole, even though some parts of the full data model are in the other resources of this module. The full product is actually represented by several resources working together - it can be thought of as one large model.

Each part can be used individually to represent some aspects of the full product. But the product as a whole, should be a MedicinalProductDefinition. (As an example, if just a representation of the individual tablet of a product is needed, just the ManufacturedItemDefinition resource can be used. But that doesn't make the tablet into a "product" - it is still just the physical manifestation of an overall drug product. There is logically a MedicinalProductDefinition there too, even if it is not being used or transmitted at this time.)

The MedicinalProductDefinition resource acts as a "header", representing the product itself, and is the unit that is generally submitted for regulation (and is approved for sale), or that appears in a drug catalog or pharmacopoeia.

A list of drug definitions would be list of MedicinalProductDefinitions, but each would have a series of associated packs and manufactured items (and ingredients etc.), with references to the appropriate resources.

The "product level" at the top has features such as names and identifiers, classifications, legal status, and usage characteristics (indications, contra-indications) since they are common to all package types available for this product, the tablets (or powders etc.) that physically are the medication, as well as the form of the drug that is eventually given to the patient.

A product can have multiple pack types - which may come and go over time - and the existence of differing package options (different amounts of the drug, or bottle vs. packet) is one of the reasons to have an overarching product record that collates them all.

A product is normally limited to a single formulation (set of ingredients) and physical form and strength. These defining characteristics are some of the key features that marketing approvals and approved usage indications are based on. A change of any of these would usually mean a different product - a different MedicinalProductDefinition instance - and a different approval being needed.

A key aspect of a regulated medicinal product is the authorization (marketing authorization). This is not directly carried on the product resource, but instead a RegulatedAuthorization resource is created which points back to this resource.

Due to the amount of information, cardinalities, and update granularity necessary for some applications, the full product model is split over several resources.

If you need just a coded "package type" list for your product you can use MedicinalProductDefinition.packagedMedicinalProduct. But full package information goes in an instance of PackagedProductDefinition resource (linked back to the MedicinalProductDefinition using PackagedProductDefinition.productFor).

There are occasions where an identified package is not necessary, and yet one or more parts of the PackagedProductDefinition resource are needed. In this case it may be appropriate to use a contained PackagedProductDefinition resource. Similarly if the Ingredient resource is too much, but a link to a substance as component part of a product is needed, consider a contained Ingredient, that links straight to a SubstanceDefinition.

This example demonstrates both of these cases.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition TU DomainResource Detailed definition of a medicinal product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ 0..* Identifier Business identifier for this product. Could be an MPID

... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: Medicinal Product Type (Example)
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses
Binding: Medicinal Product Domain (Example)
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (Preferred)
... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Combined Dose Form (Example)
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: SNOMED CT Route Codes (Example)

... indication Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: Legal Status Of Supply (Example)
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: Additional Monitoring (Example)
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: Special Measures (Example)

... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: Pediatric Use (Example)
... classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Binding: Product Classification (Example)

... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization

... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: Medicinal Product Package Type (Example)

... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes

... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMED CT Substance Codes (Example)

... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMED CT Substance Codes (Example)

... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product

... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)

... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization

.... type Σ 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: Product Contact Type (Example)
.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in

... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMED CT Medication Codes (Example)

... name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts

.... productName Σ 1..1 string The full product name
.... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Product Name Type (Example)
.... part Σ 0..* BackboneElement Coding words or phrases of the name

..... part Σ 1..1 string A fragment of a product name
..... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: Product Name Part Type (Example)
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies

..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: Country ValueSet (Example)
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: Jurisdiction ValueSet (Example)
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: All Languages (Required)
Additional BindingsPurpose
Common Languages Starter Set

... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product

.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: Product Cross Reference Type (Example)
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product

.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer

.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: Product Confidentiality (Example)
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"

.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Product Characteristic (Example)
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format icon

See the Extensions for this resource

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

Path ValueSet Type Documentation
MedicinalProductDefinition.type MedicinalProductType Example

Overall defining type of this Medicinal Product.

MedicinalProductDefinition.domain MedicinalProductDomain Example

Applicable domain for this product (e.g. human, veterinary)

MedicinalProductDefinition.status PublicationStatus Preferred

The lifecycle status of an artifact.

MedicinalProductDefinition.combinedPharmaceuticalDoseForm CombinedDoseForm Example

Dose forms for a product as a whole, considering all individual parts, but before any mixing

MedicinalProductDefinition.route SNOMEDCTRouteCodes Example

This value set includes all Route codes from SNOMED CT - provided as an exemplar.

MedicinalProductDefinition.legalStatusOfSupply LegalStatusOfSupply Example

The prescription supply types appropriate to a medicinal product

MedicinalProductDefinition.additionalMonitoringIndicator AdditionalMonitoring Example

Extra monitoring defined for a Medicinal Product.

MedicinalProductDefinition.specialMeasures SpecialMeasures Example

Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.

MedicinalProductDefinition.pediatricUseIndicator PediatricUse Example

Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

MedicinalProductDefinition.classification ProductClassification (a valid code from WHO ATC icon) Example

This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

MedicinalProductDefinition.packagedMedicinalProduct MedicinalProductPackageType Example

Types of medicinal product packs

MedicinalProductDefinition.ingredient SNOMEDCTSubstanceCodes Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

MedicinalProductDefinition.impurity SNOMEDCTSubstanceCodes Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

MedicinalProductDefinition.contact.type ProductContactType Example

Contact type for a Medicinal Product.

MedicinalProductDefinition.code SNOMEDCTMedicationCodes Example

This value set includes all drug or medicament substance codes and all pharmaceutical/biologic products from SNOMED CT - provided as an exemplar value set.

MedicinalProductDefinition.name.type ProductNameType Example

Type of a name for a Medicinal Product.

MedicinalProductDefinition.name.part.type ProductNamePartType Example

Type of part of a name for a Medicinal Product.

MedicinalProductDefinition.name.usage.country CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code icon) Example

This value set defines a base set of codes for countries.

Note: The codes for countries are taken from ISO 3166 icon.

MedicinalProductDefinition.name.usage.jurisdiction JurisdictionValueSet Example

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.

MedicinalProductDefinition.name.usage.language AllLanguages (a valid code from Tags for the Identification of Languages icon) Required

This value set includes all possible codes from BCP-47 (see http://tools.ietf.org/html/bcp47)

  Common Languages starter
MedicinalProductDefinition.crossReference.type ProductCrossReferenceType Example

Relationship to another Medicinal Product.

MedicinalProductDefinition.operation.confidentialityIndicator ProductConfidentiality Example

Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

MedicinalProductDefinition.characteristic.type ProductCharacteristic Example

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.



Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
characteristic token Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import" MedicinalProductDefinition.characteristic.value.ofType(Quantity) | MedicinalProductDefinition.characteristic.value.ofType(CodeableConcept)
characteristic-type token A category for the characteristic MedicinalProductDefinition.characteristic.type
contact reference A product specific contact, person (in a role), or an organization MedicinalProductDefinition.contact.contact
(Organization, PractitionerRole)
domain token If this medicine applies to human or veterinary uses MedicinalProductDefinition.domain
identifier token Business identifier for this product. Could be an MPID MedicinalProductDefinition.identifier
ingredient token An ingredient of this product MedicinalProductDefinition.ingredient
master-file reference A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) MedicinalProductDefinition.masterFile
(DocumentReference)
name string The full product name MedicinalProductDefinition.name.productName
name-language token Language code for this name MedicinalProductDefinition.name.usage.language
product-classification token Allows the product to be classified by various systems MedicinalProductDefinition.classification
status token The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status MedicinalProductDefinition.status
type token Regulatory type, e.g. Investigational or Authorized MedicinalProductDefinition.type