Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs).

Business identifier for this product. Could be an MPID.

Regulatory type, e.g. Investigational or Authorized.

If this medicine applies to human or veterinary uses.

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. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.

The date at which the given status became applicable.

General description of this product.

The dose form for a single part product, or combined form of a multiple part product.

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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate.

The legal status of supply of the medicinal product as classified by the regulator.

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.

Whether the Medicinal Product is subject to special measures for regulatory reasons.

If authorised for use in children.

Allows the product to be classified by various systems.

Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

Marketing status of the medicinal product, in contrast to marketing authorization.

The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here.

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 information or supporting documentation about the medicinal product.

A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).

A product specific contact, person (in a role), or an organization.

Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

A product specific contact, person (in a role), or an organization.

Clinical trials or studies that this product is involved in.

The product's name, including full name and possibly coded parts.

The full product name.

Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

Coding words or phrases of the name.

A fragment of a product name.

Identifying type for this part of the name (e.g. strength part).

Country where the name applies.

Country code for where this name applies.

Jurisdiction code for where this name applies.

Language code for this name.

Reference to another product, e.g. for linking authorised to investigational product.

Reference to another product, e.g. for linking authorised to investigational product.

The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version.

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. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute.

Date range of applicability.

The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.

An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part.

Specifies whether this particular business or manufacturing process is considered proprietary or confidential.

Package representation for the product.

A descriptive type for this package, such as box, carton or bottle.

The amount of items, or of substance, in the package.

Full package representation for the product.

The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item.

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.

Full description of the administrable product.