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. Model is suitable for generic/virtual medications as well as branded/real products.

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.

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

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.

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

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.

EDQM Standard Terms

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

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

Dose form

EDQM Standard Terms

Ingredients

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

Substance

EMA SPOR SMS

Strength of the product - amount of substance per unit

Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet

Substance that the strength refers to, in case it's different from the main substance

EMA SPOR SMS

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

EDQM Standard Terms

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

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

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

Type of package of the medication item

EDQM Standard Terms for packaging.

Administration device included in the product

Number of such devices

Device coded

Other features of the product

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.

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. Model is suitable for generic/virtual medications as well as branded/real products.

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.

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

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.

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

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.

EDQM Standard Terms

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

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

Dose form

EDQM Standard Terms

Ingredients

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

Substance

EMA SPOR SMS

Strength of the product - amount of substance per unit

Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet

Substance that the strength refers to, in case it's different from the main substance

EMA SPOR SMS

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

EDQM Standard Terms

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

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

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

Type of package of the medication item

EDQM Standard Terms for packaging.

Administration device included in the product

Number of such devices

Device coded

Other features of the product

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.

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. Model is suitable for generic/virtual medications as well as branded/real products.

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.

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

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.

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

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.

EDQM Standard Terms

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

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

Dose form

EDQM Standard Terms

Ingredients

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

Substance

EMA SPOR SMS

Strength of the product - amount of substance per unit

Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet

Substance that the strength refers to, in case it's different from the main substance

EMA SPOR SMS

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

EDQM Standard Terms

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

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

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

Type of package of the medication item

EDQM Standard Terms for packaging.

Administration device included in the product

Number of such devices

Device coded

Other features of the product

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.

Batch identifier of the medicinal product

Batch expiration date of the medicinal product.