An Extension

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 manageable, 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.

• unordered
• Open
• discriminators: value:url

The date at which the drug substance or drug product was manufactured. The specific operation/step in the process used to determine the date is specified by the manufacturingDateClassification element.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

A code that provides a rationale for the selection of the manufacturing date.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Describes the details of the actual manufacturer who produced this product on behalf of the sponsor or who wholly or partially produced the medication product. This is intended to identify the exact manufacturing location.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

A code that provides a rationale for the selection of the expiration date.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

A categorization of the batch that identifies its usage. Examples: commercial, development, etc.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

The amount of drug product produced in this batch.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

A placeholder for providing any comments that are relevant to the batch. Examples: first batch manufactured at a new facility; first batch manufactured using a new Active Pharmaceutical Ingredient (API) source, new process, new container closure, etc.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Information that applies to how the batch was packaged.

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 manageable, 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.

• unordered
• Open
• discriminators: value:url

A combination of letters, numbers, or symbols, or any combination of them to uniquely identify the container's manufacturing lot.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

The kind of container that drug substances and finished dosage forms are contained in, which could include both the immediate (or primary) and secondary containers.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Amount or volume of the drug product in the container. Expressed as a ratio of the amount of drug per volume of container.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

A description of the sum of container closure system (CCS) components that together contain and protect the dosage form or drug substance.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

The kind of closures used for the container in which the drug substances and finished dosage forms are stored.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

• unordered
• Open
• discriminators: value:url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).