Generated Narrative: StructureDefinition emaWriteApiMedicinalProductDefinitionRestrictions Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> MedicinalProductDefinition MedicinalProductDefinition implicitRules 0..0 language 0..0 text 0..0 contained 0..0 modifierExtension 0..0 version 0..0 statusDate 0..0 description 0..0 route 0..0 specialMeasures 0..0 marketingStatus 0..0 packagedMedicinalProduct 0..0 ingredient 0..0 impurity 0..0 code 0..0 <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
EMA Write API MedicinalProductDefinition Restrictions
Defines the restrictive rules a MedicinalProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
Detailed definition of a medicinal product
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).
If the resource is contained in another resource, it SHALL NOT contain nested Resources
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
Medicinal Product and Investigational Medicinal Product
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Must have either extensions or value[x], not both
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Business identifier for this product. Could be an MPID
Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.
Medicinal Product.MPID, Investigational Medicinal Product.IMPID
Regulatory type, e.g. Investigational or Authorized
Regulatory type, e.g. Investigational or Authorized.
Overall defining type of this medicinal product.
(indicates if this is Medicinal Product or an Investigational Medicinal Product)
If this medicine applies to human or veterinary uses
If this medicine applies to human or veterinary uses.
Applicable domain for this product (e.g. human, veterinary).
A business identifier relating to a specific version of the product
A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.
The status within the lifecycle of this product record
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.
This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
The date at which the given status became applicable
The date at which the given status became applicable.
The dose form for a single part product, or combined form of a multiple part product
The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).
Dose forms for a product as a whole, considering all individual parts, but before any mixing
Medicinal Product.Combined Pharmaceutical Dose Form
The path by which the product is taken into or makes contact with the body
The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.
A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
Pharmaceutical Product.Route of Administration
Description of indication(s) for this product, used when structured indications are not required
Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.
(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
The legal status of supply of the medicinal product as classified by the regulator
The legal status of supply of the medicinal product as classified by the regulator.
The prescription supply types appropriate to a medicinal product
Marketing Authorisation.Legal Status of Supply (moved here for practicality)
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.
Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
Medicinal Product.Additional Monitoring Indicator
Whether the Medicinal Product is subject to special measures for regulatory reasons
Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.
Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
If authorised for use in children, or infants, neonates etc.
Suitability for age groups, in particular children.
Medicinal Product.Pediatric Use Indicator
Allows the product to be classified by various systems
Allows the product to be classified by various systems, commonly WHO ATC.
This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
Marketing status of the medicinal product, in contrast to marketing authorization
Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).
Package type for the product. See also the PackagedProductDefinition resource.
Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).
The ingredients of this medicinal product - when not detailed in other resources
The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.
This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Medicinal Product.Ingredient (see also FHIR Ingredient resource)
Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.
Additional documentation about the medicinal product
Additional information or supporting documentation about the medicinal product.
A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.
A product specific contact, person (in a role), or an organization
A product specific contact, person (in a role), or an organization.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.
Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
Clinical trials or studies that this product is involved in
Clinical trials or studies that this product is involved in.
Investigational Medicinal Product.Clinical Trial Status
A code that this product is known by, within some formal terminology
A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.
A coded concept that defines the type of a medication.
The product's name, including full name and possibly coded parts
The product's name, including full name and possibly coded parts.
Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.
(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)
(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)
Identifying type for this part of the name (e.g. strength part)
Identifying type for this part of the name (e.g. strength part).
Type of part of a name for a Medicinal Product.
(which of the name parts this is e.g. Formulation Part)
Country and jurisdiction where the name applies
Country and jurisdiction where the name applies, and associated language.
Country code for where this name applies
Country code for where this name applies.
Jurisdiction code for where this name applies
Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).
Reference to another product, e.g. for linking authorised to investigational product
Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.
Reference to another product, e.g. for linking authorised to investigational product.
The type of relationship, for instance branded to generic or virtual to actual product
The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.
A manufacturing or administrative process for the medicinal product
A manufacturing or administrative process or step associated with (or performed on) the medicinal product.
The type of manufacturing operation e.g. manufacturing itself, re-packaging
The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.
Manufacturing / Business Operation.Operation Type
Manufacturing / Business Operation.Effective Date
The organization responsible for the particular process, e.g. the manufacturer or importer
The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.
Manufacturer / Establishment (Organisation)
Specifies whether this process is considered proprietary or confidential
Specifies whether this particular business or manufacturing process is considered proprietary or confidential.
Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
Manufacturing / Business Operation.Confidentiality Indicator
Key product features such as "sugar free", "modified release"
Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".
Package Item (Container).Physical Characteristics
A code expressing the type of characteristic
A code expressing the type of characteristic.
This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Physical Characteristics, all attributes
Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text.
Physical Characteristics, attribute's value