Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile.

Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.

Non-conflicting change

Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)

No change

WHO ATC

Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.

No change

Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product.

No change, but subelements added

Name of the organisation holding the authorisation for marketing/mahufacturing

Identifier of the organisation and/or its physical location

Dose form(s) on a product level. Dose form for a single package item is defined below.

No change

EDQM Standard Terms

Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)

No change

UCUM for units of measure. EDQM Standard Terms for units of presentation.

A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined

Structure changed, elements repeated for complex packages

Dose form

No change

EDQM Standard Terms

Ingredients

No conflicting change

Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.

Added

Substance

EMA SPOR SMS

Concentration or presentation strength

Concentration or presentation strength of the precise active ingredient

No change

Type of strength that is expressed

Added

Substance that the strength refers to, if different from the main substance

Added (eHN guidelines A.1.4.4.1 'in addition reference strength could be provided')

EMA SPOR SMS

Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.

No change

EDQM Standard Terms

Manufactured item quantity for liquids (3ml / 1 vial)

Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)

Number of such manufactured items in this product (5 vials)

Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)

UCUM for units of measure. EDQM Standard Terms for units of presentation.

Type of package of the medication item

Added (eHN guidelines A.1.4.8 Package type)

EDQM Standard Terms for packaging.

Administration device included in the product

Number of such devices

Device coded

Added

Other features of the product

Added for any other information. Currently missing from the model A.1.4.8 Package type (unit of presentation sometimes providing this info)

A code expressing the type of characteristic

Description of the characteristic

Additional information about product - for example, a reference to a product catalogue

Added

Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile.

Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.

Non-conflicting change

Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)

No change

WHO ATC

Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.

No change

Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product.

No change, but subelements added

Name of the organisation holding the authorisation for marketing/mahufacturing

Identifier of the organisation and/or its physical location

Dose form(s) on a product level. Dose form for a single package item is defined below.

No change

EDQM Standard Terms

Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)

No change

UCUM for units of measure. EDQM Standard Terms for units of presentation.

A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined

Structure changed, elements repeated for complex packages

Dose form

No change

EDQM Standard Terms

Ingredients

No conflicting change

Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.

Added

Substance

EMA SPOR SMS

Concentration or presentation strength

Concentration or presentation strength of the precise active ingredient

No change

Type of strength that is expressed

Added

Substance that the strength refers to, if different from the main substance

Added (eHN guidelines A.1.4.4.1 'in addition reference strength could be provided')

EMA SPOR SMS

Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.

No change

EDQM Standard Terms

Manufactured item quantity for liquids (3ml / 1 vial)

Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)

Number of such manufactured items in this product (5 vials)

Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)

UCUM for units of measure. EDQM Standard Terms for units of presentation.

Type of package of the medication item

Added (eHN guidelines A.1.4.8 Package type)

EDQM Standard Terms for packaging.

Administration device included in the product

Number of such devices

Device coded

Added

Other features of the product

Added for any other information. Currently missing from the model A.1.4.8 Package type (unit of presentation sometimes providing this info)

A code expressing the type of characteristic

Description of the characteristic

Additional information about product - for example, a reference to a product catalogue

Added

Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile.

Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.

Non-conflicting change

Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)

No change

WHO ATC

Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.

No change

Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product.

No change, but subelements added

Name of the organisation holding the authorisation for marketing/mahufacturing

Identifier of the organisation and/or its physical location

Dose form(s) on a product level. Dose form for a single package item is defined below.

No change

EDQM Standard Terms

Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)

No change

UCUM for units of measure. EDQM Standard Terms for units of presentation.

A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined

Structure changed, elements repeated for complex packages

Dose form

No change

EDQM Standard Terms

Ingredients

No conflicting change

Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.

Added

Substance

EMA SPOR SMS

Concentration or presentation strength

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.

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.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Concentration or presentation strength of the precise active ingredient

No change

Type of strength that is expressed

Added

Substance that the strength refers to, if different from the main substance

Added (eHN guidelines A.1.4.4.1 'in addition reference strength could be provided')

EMA SPOR SMS

Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.

No change

EDQM Standard Terms

Manufactured item quantity for liquids (3ml / 1 vial)

Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)

Number of such manufactured items in this product (5 vials)

Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)

UCUM for units of measure. EDQM Standard Terms for units of presentation.

Type of package of the medication item

Added (eHN guidelines A.1.4.8 Package type)

EDQM Standard Terms for packaging.

Administration device included in the product

Number of such devices

Device coded

Added

Other features of the product

Added for any other information. Currently missing from the model A.1.4.8 Package type (unit of presentation sometimes providing this info)

A code expressing the type of characteristic

Description of the characteristic

Additional information about product - for example, a reference to a product catalogue

Added