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

Strength of the product - amount of substance per unit

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

Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.

Added from Patient Summary

Batch identifier of the medicinal product

Batch expiration date of the medicinal product.

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

Strength of the product - amount of substance per unit

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

Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.

Added from Patient Summary

Batch identifier of the medicinal product

Batch expiration date of the medicinal product.

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

Strength of the product - amount of substance per unit

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

Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.

Added from Patient Summary

Batch identifier of the medicinal product

Batch expiration date of the medicinal product.