--- type: "resource" title: "MedicinalProductDefinition" resource: "MedicinalProductDefinition" --- # MedicinalProductDefinition ## Introduction ## Scope and Usage **_For an overview of this resource and others in the Medication Definition domain, also see the [module page](medication-definition-module)_** 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](medication)). This product resource is associated with others that describe the [packaging](packagedproductdefinition), the actual medication in its [manufactured form](manufactureditemdefinition) (e.g. the tablet itself), its [ingredients](ingredient), and the [substances](substancedefinition) within. These products are generally regulated by national or regional bodies or agencies. See note below about the [RegulatedAuthorization](#auth) 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](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. ### Authorizations 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](regulatedauthorization) resource is created which points back to this resource. ### Contained Resources 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](medicinalproductdefinition-with-contained-package-and-ingredient) demonstrates both of these cases. ## StructureDefinition ### Elements (Simplified) - **[MedicinalProductDefinition](/medicinalproductdefinition-definitions#MedicinalProductDefinition)** [0..*]: - Detailed definition of a medicinal product - **[MedicinalProductDefinition.identifier](/medicinalproductdefinition-definitions#MedicinalProductDefinition.identifier)** [0..*]: [Identifier](/Identifier) Business identifier for this product. Could be an MPID - **[MedicinalProductDefinition.type](/medicinalproductdefinition-definitions#MedicinalProductDefinition.type)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-type](/valueset-medicinal-product-type) Regulatory type, e.g. Investigational or Authorized - **[MedicinalProductDefinition.domain](/medicinalproductdefinition-definitions#MedicinalProductDefinition.domain)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-domain](/valueset-medicinal-product-domain) If this medicine applies to human or veterinary uses - **[MedicinalProductDefinition.version](/medicinalproductdefinition-definitions#MedicinalProductDefinition.version)** [0..1]: [string](/string) A business identifier relating to a specific version of the product - **[MedicinalProductDefinition.status](/medicinalproductdefinition-definitions#MedicinalProductDefinition.status)** [0..1]: [CodeableConcept](/CodeableConcept) preferred:[publication-status](/valueset-publication-status) The status within the lifecycle of this product record - **[MedicinalProductDefinition.statusDate](/medicinalproductdefinition-definitions#MedicinalProductDefinition.statusDate)** [0..1]: [dateTime](/dateTime) The date at which the given status became applicable - **[MedicinalProductDefinition.description](/medicinalproductdefinition-definitions#MedicinalProductDefinition.description)** [0..1]: [markdown](/markdown) General description of this product - **[MedicinalProductDefinition.combinedPharmaceuticalDoseForm](/medicinalproductdefinition-definitions#MedicinalProductDefinition.combinedPharmaceuticalDoseForm)** [0..1]: [CodeableConcept](/CodeableConcept) example:[combined-dose-form](/valueset-combined-dose-form) The dose form for a single part product, or combined form of a multiple part product - **[MedicinalProductDefinition.route](/medicinalproductdefinition-definitions#MedicinalProductDefinition.route)** [0..*]: [CodeableConcept](/CodeableConcept) example:[route-codes](/valueset-route-codes) The path by which the product is taken into or makes contact with the body - **[MedicinalProductDefinition.indication](/medicinalproductdefinition-definitions#MedicinalProductDefinition.indication)** [0..1]: [markdown](/markdown) Description of indication(s) for this product, used when structured indications are not required - **[MedicinalProductDefinition.legalStatusOfSupply](/medicinalproductdefinition-definitions#MedicinalProductDefinition.legalStatusOfSupply)** [0..1]: [CodeableConcept](/CodeableConcept) example:[legal-status-of-supply](/valueset-legal-status-of-supply) The legal status of supply of the medicinal product as classified by the regulator - **[MedicinalProductDefinition.additionalMonitoringIndicator](/medicinalproductdefinition-definitions#MedicinalProductDefinition.additionalMonitoringIndicator)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-additional-monitoring](/valueset-medicinal-product-additional-monitoring) Whether the Medicinal Product is subject to additional monitoring for regulatory reasons - **[MedicinalProductDefinition.specialMeasures](/medicinalproductdefinition-definitions#MedicinalProductDefinition.specialMeasures)** [0..*]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-special-measures](/valueset-medicinal-product-special-measures) Whether the Medicinal Product is subject to special measures for regulatory reasons - **[MedicinalProductDefinition.pediatricUseIndicator](/medicinalproductdefinition-definitions#MedicinalProductDefinition.pediatricUseIndicator)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-pediatric-use](/valueset-medicinal-product-pediatric-use) If authorised for use in children - **[MedicinalProductDefinition.classification](/medicinalproductdefinition-definitions#MedicinalProductDefinition.classification)** [0..*]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-classification](/valueset-medicinal-product-classification) Allows the product to be classified by various systems - **[MedicinalProductDefinition.marketingStatus](/medicinalproductdefinition-definitions#MedicinalProductDefinition.marketingStatus)** [0..*]: [MarketingStatus](/MarketingStatus) Marketing status of the medicinal product, in contrast to marketing authorization - **[MedicinalProductDefinition.packagedMedicinalProduct](/medicinalproductdefinition-definitions#MedicinalProductDefinition.packagedMedicinalProduct)** [0..*]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-package-type](/valueset-medicinal-product-package-type) Package type for the product - **[MedicinalProductDefinition.comprisedOf](/medicinalproductdefinition-definitions#MedicinalProductDefinition.comprisedOf)** [0..*]: [Reference(ManufacturedItemDefinition](/Reference(ManufacturedItemDefinition), [DeviceDefinition)](/DeviceDefinition)) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes - **[MedicinalProductDefinition.ingredient](/medicinalproductdefinition-definitions#MedicinalProductDefinition.ingredient)** [0..*]: [CodeableConcept](/CodeableConcept) example:[substance-codes](/valueset-substance-codes) The ingredients of this medicinal product - when not detailed in other resources - **[MedicinalProductDefinition.impurity](/medicinalproductdefinition-definitions#MedicinalProductDefinition.impurity)** [0..*]: [CodeableReference](/CodeableReference) example:[substance-codes](/valueset-substance-codes) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product - **[MedicinalProductDefinition.attachedDocument](/medicinalproductdefinition-definitions#MedicinalProductDefinition.attachedDocument)** [0..*]: Reference([DocumentReference](/DocumentReference)) Additional documentation about the medicinal product - **[MedicinalProductDefinition.masterFile](/medicinalproductdefinition-definitions#MedicinalProductDefinition.masterFile)** [0..*]: Reference([DocumentReference](/DocumentReference)) A master file for the medicinal product (e.g. Pharmacovigilance System Master File) - **[MedicinalProductDefinition.contact](/medicinalproductdefinition-definitions#MedicinalProductDefinition.contact)** [0..*]: [BackboneElement](/BackboneElement) A product specific contact, person (in a role), or an organization - **[MedicinalProductDefinition.contact.type](/medicinalproductdefinition-definitions#MedicinalProductDefinition.contact.type)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-contact-type](/valueset-medicinal-product-contact-type) Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information - **[MedicinalProductDefinition.contact.contact](/medicinalproductdefinition-definitions#MedicinalProductDefinition.contact.contact)** [1..1]: [Reference(Organization](/Reference(Organization), [PractitionerRole)](/PractitionerRole)) A product specific contact, person (in a role), or an organization - **[MedicinalProductDefinition.clinicalTrial](/medicinalproductdefinition-definitions#MedicinalProductDefinition.clinicalTrial)** [0..*]: Reference([ResearchStudy](/ResearchStudy)) Clinical trials or studies that this product is involved in - **[MedicinalProductDefinition.code](/medicinalproductdefinition-definitions#MedicinalProductDefinition.code)** [0..*]: [Coding](/Coding) example:[medication-codes](/valueset-medication-codes) A code that this product is known by, within some formal terminology - **[MedicinalProductDefinition.name](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name)** [1..*]: [BackboneElement](/BackboneElement) The product's name, including full name and possibly coded parts - **[MedicinalProductDefinition.name.productName](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.productName)** [1..1]: [string](/string) The full product name - **[MedicinalProductDefinition.name.type](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.type)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-name-type](/valueset-medicinal-product-name-type) Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary - **[MedicinalProductDefinition.name.part](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.part)** [0..*]: [BackboneElement](/BackboneElement) Coding words or phrases of the name - **[MedicinalProductDefinition.name.part.part](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.part.part)** [1..1]: [string](/string) A fragment of a product name - **[MedicinalProductDefinition.name.part.type](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.part.type)** [1..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-name-part-type](/valueset-medicinal-product-name-part-type) Identifying type for this part of the name (e.g. strength part) - **[MedicinalProductDefinition.name.usage](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.usage)** [0..*]: [BackboneElement](/BackboneElement) Country and jurisdiction where the name applies - **[MedicinalProductDefinition.name.usage.country](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.usage.country)** [1..1]: [CodeableConcept](/CodeableConcept) example:[country](/valueset-country) Country code for where this name applies - **[MedicinalProductDefinition.name.usage.jurisdiction](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.usage.jurisdiction)** [0..1]: [CodeableConcept](/CodeableConcept) example:[jurisdiction](/valueset-jurisdiction) Jurisdiction code for where this name applies - **[MedicinalProductDefinition.name.usage.language](/medicinalproductdefinition-definitions#MedicinalProductDefinition.name.usage.language)** [1..1]: [CodeableConcept](/CodeableConcept) required:[all-languages](/valueset-all-languages) Language code for this name - **[MedicinalProductDefinition.crossReference](/medicinalproductdefinition-definitions#MedicinalProductDefinition.crossReference)** [0..*]: [BackboneElement](/BackboneElement) Reference to another product, e.g. for linking authorised to investigational product - **[MedicinalProductDefinition.crossReference.product](/medicinalproductdefinition-definitions#MedicinalProductDefinition.crossReference.product)** [1..1]: [CodeableReference](/CodeableReference) Reference to another product, e.g. for linking authorised to investigational product - **[MedicinalProductDefinition.crossReference.type](/medicinalproductdefinition-definitions#MedicinalProductDefinition.crossReference.type)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-cross-reference-type](/valueset-medicinal-product-cross-reference-type) The type of relationship, for instance branded to generic or virtual to actual product - **[MedicinalProductDefinition.operation](/medicinalproductdefinition-definitions#MedicinalProductDefinition.operation)** [0..*]: [BackboneElement](/BackboneElement) A manufacturing or administrative process for the medicinal product - **[MedicinalProductDefinition.operation.type](/medicinalproductdefinition-definitions#MedicinalProductDefinition.operation.type)** [0..1]: [CodeableReference](/CodeableReference) The type of manufacturing operation e.g. manufacturing itself, re-packaging - **[MedicinalProductDefinition.operation.effectiveDate](/medicinalproductdefinition-definitions#MedicinalProductDefinition.operation.effectiveDate)** [0..1]: [Period](/Period) Date range of applicability - **[MedicinalProductDefinition.operation.organization](/medicinalproductdefinition-definitions#MedicinalProductDefinition.operation.organization)** [0..*]: Reference([Organization](/Organization)) The organization responsible for the particular process, e.g. the manufacturer or importer - **[MedicinalProductDefinition.operation.confidentialityIndicator](/medicinalproductdefinition-definitions#MedicinalProductDefinition.operation.confidentialityIndicator)** [0..1]: [CodeableConcept](/CodeableConcept) example:[medicinal-product-confidentiality](/valueset-medicinal-product-confidentiality) Specifies whether this process is considered proprietary or confidential - **[MedicinalProductDefinition.characteristic](/medicinalproductdefinition-definitions#MedicinalProductDefinition.characteristic)** [0..*]: [BackboneElement](/BackboneElement) Key product features such as "sugar free", "modified release" - **[MedicinalProductDefinition.characteristic.type](/medicinalproductdefinition-definitions#MedicinalProductDefinition.characteristic.type)** [1..1]: [CodeableConcept](/CodeableConcept) example:[product-characteristic-codes](/valueset-product-characteristic-codes) A code expressing the type of characteristic - **[MedicinalProductDefinition.characteristic.value[x]](/medicinalproductdefinition-definitions#MedicinalProductDefinition.characteristic.value%5Bx%5D)** [0..1]: [CodeableConcept](/CodeableConcept), [markdown](/markdown), [Quantity](/Quantity), [Range](/Range), [integer](/integer), [date](/date), [boolean](/boolean), [Attachment](/Attachment) A value for the characteristic ## Mappings - [MedicinalProductDefinition Mappings](/medicinalproductdefinition-mappings) — 100 mapping entries ## Operations - [everything](/medicinalproductdefinition-operation-everything) — Fetch Product Record — This operation is used to return all the information related to one or more products described in the resource or context on which this operation is invoked. [Full Operations](/medicinalproductdefinition-operations) ## Resource Packs ### list-MedicinalProductDefinition-packs.xml ```xml ``` ## Search Parameters - [characteristic](/medicinalproductdefinition-search#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](/medicinalproductdefinition-search#characteristic-type) — **token** — A category for the characteristic — `MedicinalProductDefinition.characteristic.type` - [contact](/medicinalproductdefinition-search#contact) — **reference** — A product specific contact, person (in a role), or an organization — `MedicinalProductDefinition.contact.contact` - [domain](/medicinalproductdefinition-search#domain) — **token** — If this medicine applies to human or veterinary uses — `MedicinalProductDefinition.domain` - [identifier](/medicinalproductdefinition-search#identifier) — **token** — Business identifier for this product. Could be an MPID — `MedicinalProductDefinition.identifier` - [ingredient](/medicinalproductdefinition-search#ingredient) — **token** — An ingredient of this product — `MedicinalProductDefinition.ingredient` - [master-file](/medicinalproductdefinition-search#master-file) — **reference** — A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) — `MedicinalProductDefinition.masterFile` - [name](/medicinalproductdefinition-search#name) — **string** — The full product name — `MedicinalProductDefinition.name.productName` - [name-language](/medicinalproductdefinition-search#name-language) — **token** — Language code for this name — `MedicinalProductDefinition.name.usage.language` - [product-classification](/medicinalproductdefinition-search#product-classification) — **token** — Allows the product to be classified by various systems — `MedicinalProductDefinition.classification` - [status](/medicinalproductdefinition-search#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](/medicinalproductdefinition-search#type) — **token** — Regulatory type, e.g. Investigational or Authorized — `MedicinalProductDefinition.type` - [operation-type](/medicinalproductdefinition-search#operation-type) — **reference** — The type of manufacturing operation, as a reference to a plan or activity — `MedicinalProductDefinition.operation.type.reference` - [operation-type-code](/medicinalproductdefinition-search#operation-type-code) — **token** — The type of manufacturing operation, as a coded value — `MedicinalProductDefinition.operation.type.concept` - [operation-organization](/medicinalproductdefinition-search#operation-organization) — **reference** — The organization or establishment responsible for (or associated with) the particular process or step — `MedicinalProductDefinition.operation.organization` - [operation-organization-type](/medicinalproductdefinition-search#operation-organization-type) — **composite** — Operaton organization and type, as a reference — `MedicinalProductDefinition` - [operation-organization-type-code](/medicinalproductdefinition-search#operation-organization-type-code) — **composite** — Operaton organization and type, as a code — `MedicinalProductDefinition` - [name-country](/medicinalproductdefinition-search#name-country) — **token** — A country applicable to this product, as expressed by its name properties — `MedicinalProductDefinition.name.usage.country` [Full Search Parameters](/medicinalproductdefinition-search) ## Examples - [Acetamin-500-20-generic](/medicinalproductdefinition-example-Acetamin-500-20-generic) — medicinalproductdefinition-acetaminophen-500mg-tablets-box-of-20 — Acetaminophin product, pack and tablet (using contained resources) - [drug-and-device](/medicinalproductdefinition-example-drug-and-device) — medicinalproductdefinition-example-co-packaged-liquid-and-syringe — A liquid that comes with a syringe in the pack, basic details only - [drug-and-device-complete](/medicinalproductdefinition-example-drug-and-device-complete) — medicinalproductdefinition-example-co-packaged-liquid-and-syringe-complete — A powder and solution for injection that comes with a syringe in the pack (complete example) - [drug-combo-product](/medicinalproductdefinition-example-drug-combo-product) — medicinalproductdefinition-example-combo-product — Combination product - tablet and cream co-packaged and showing layers (as one resource, with others contained) - [drug-combo-product-bundle](/medicinalproductdefinition-example-drug-combo-product-bundle) — medicinalproductdefinition-example-combo-product-bundle — Combination product - tablet and cream co-packaged and showing layers (same but as a bundle) - [equilidem-basics](/medicinalproductdefinition-example-equilidem-basics) — medicinalproductdefinition-example-equilidem-basics — Basic details of a product, only using MedicinalProductDefinition and no other resources - [equilidem-with-ing-and-auth](/medicinalproductdefinition-example-equilidem-with-ing-and-auth) — medicinalproductdefinition-example-equilidem-using-ingredient-and-auth — Simple version of a product (more than basic), only using MedicinalProductDefinition, Ingredient and RegulatedAuthorization - [example](/medicinalproductdefinition-example-example) — medicinalproductdefinition-example — General example - [medicinalproductdefinition-example](/medicinalproductdefinition-example-medicinalproductdefinition-example) — medicinalproductdefinition-example - [medicinalproductdefinition-example-co-packaged-liquid-and-syringe](/medicinalproductdefinition-example-medicinalproductdefinition-example-co-packaged-liquid-and-syringe) — medicinalproductdefinition-example-co-packaged-liquid-and-syringe - [medicinalproductdefinition-example-co-packaged-liquid-and-syringe-complete](/medicinalproductdefinition-example-medicinalproductdefinition-example-co-packaged-liquid-and-syringe-complete) — medicinalproductdefinition-example-co-packaged-liquid-and-syringe-complete - [medicinalproductdefinition-example-combo-product](/medicinalproductdefinition-example-medicinalproductdefinition-example-combo-product) — medicinalproductdefinition-example-combo-product - [medicinalproductdefinition-example-combo-product-bundle](/medicinalproductdefinition-example-medicinalproductdefinition-example-combo-product-bundle) — medicinalproductdefinition-example-combo-product-bundle - [medicinalproductdefinition-example-equilidem-basics](/medicinalproductdefinition-example-medicinalproductdefinition-example-equilidem-basics) — medicinalproductdefinition-example-equilidem-basics - [medicinalproductdefinition-example-equilidem-using-ingredient-and-auth](/medicinalproductdefinition-example-medicinalproductdefinition-example-equilidem-using-ingredient-and-auth) — medicinalproductdefinition-example-equilidem-using-ingredient-and-auth - [medicinalproductdefinition-examples-header](/medicinalproductdefinition-example-medicinalproductdefinition-examples-header) — medicinalproductdefinition-examples-header - [product-with-contained-package-and-ingredient](/medicinalproductdefinition-example-product-with-contained-package-and-ingredient) — medicinalproductdefinition-with-contained-package-and-ingredient — Product with Contained Package and Ingredient [Full Examples](/medicinalproductdefinition-examples) ## Mapping Exceptions ### medicinalproductdefinition-fivews-mapping-exceptions.xml ### Unmapped Elements - **FiveWs.what** — Unknown - **FiveWs.recorded** — Unknown - **FiveWs.author** — Unknown - **FiveWs.actor** — Unknown - **FiveWs.cause** — Unknown - **FiveWs.version** — Unknown - **FiveWs.witness** — Unknown - **FiveWs.where** — Unknown - **FiveWs.context** — Unknown - **FiveWs.init** — Unknown - **FiveWs.why** — Unknown - **FiveWs.identifier** — Unknown - **FiveWs.source** — Unknown - **FiveWs.who** — Unknown - **FiveWs.grade** — Unknown - **FiveWs.status** — Unknown - **FiveWs.planned** — Unknown - **FiveWs.done** — Unknown - **FiveWs.subject** — Unknown