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

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 level identifier of the product.

The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status.

General description of this product.

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

General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication.

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.

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

Pharmaceutical aspects of product.

Package representation for the product.

The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here.

Supporting documentation, typically for regulatory submission.

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, Pharmacovigilence 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.

Idenifying 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.

An operation applied to the product, for manufacturing or adminsitrative purpose.

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 manufacturer or establishment associated with the process.

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

To indicate if this proces is commercially confidential.