Model describes the administration of immunisation products, including vaccines and immunoglobulins, covering active and passive immunisations. It focuses on immunisation as a clinical procedure rather than the resulting immunity. The model supports routine immunisations at standard doses and may overlap with medication summaries or prescription lists. Natural immunity, immunisation outcomes, refusals, and administration or planning details are out of scope.

Basic metadata for this information

Patient/subject information

Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).

The author of the immunisation statement.

Date and optionally time of authoring/issuing

Status of the immunisation event (completed, not-done).

Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.

Language in which the resource is written. Language is expressed by the IETF language tag.

BCP 47

Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus).

ICD-10, SNOMED CT

Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.

SNOMED CT, ATC

Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.

An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.

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

WHO ATC

Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.

Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.

Name of the organisation holding the authorisation for marketing/manufacturing

Identifier of the organisation and/or its physical location

Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm.

EDQM Standard Terms

Textual description of the product, e.g. including package description.

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

Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.

EDQM Standard Terms

Ingredients

Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.

Substance

EMA SPOR SMS

Strength of the product - amount of substance per unit

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

Substance that the strength refers to, especially when different from .item.strength.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 per one item (3 ml / 1 vial)

Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.

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. Devices that are not inside the medication package are excluded.

Number of such devices

Device coded

Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.

A code expressing the type of characteristic.

Description of the characteristic value.

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.

The date and optionally the exact time when the vaccination was administered.

Administering centre or a health authority responsible for the vaccination event

Health professional responsible for administering the immunisation product.

Any additional free-text information about the immunisation

Model describes the administration of immunisation products, including vaccines and immunoglobulins, covering active and passive immunisations. It focuses on immunisation as a clinical procedure rather than the resulting immunity. The model supports routine immunisations at standard doses and may overlap with medication summaries or prescription lists. Natural immunity, immunisation outcomes, refusals, and administration or planning details are out of scope.

Basic metadata for this information

Patient/subject information

Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).

The author of the immunisation statement.

Date and optionally time of authoring/issuing

Status of the immunisation event (completed, not-done).

Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.

Language in which the resource is written. Language is expressed by the IETF language tag.

BCP 47

Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus).

ICD-10, SNOMED CT

Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.

SNOMED CT, ATC

Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.

An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.

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

WHO ATC

Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.

Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.

Name of the organisation holding the authorisation for marketing/manufacturing

Identifier of the organisation and/or its physical location

Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm.

EDQM Standard Terms

Textual description of the product, e.g. including package description.

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

Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.

EDQM Standard Terms

Ingredients

Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.

Substance

EMA SPOR SMS

Strength of the product - amount of substance per unit

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

Substance that the strength refers to, especially when different from .item.strength.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 per one item (3 ml / 1 vial)

Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.

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. Devices that are not inside the medication package are excluded.

Number of such devices

Device coded

Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.

A code expressing the type of characteristic.

Description of the characteristic value.

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.

The date and optionally the exact time when the vaccination was administered.

Administering centre or a health authority responsible for the vaccination event

Health professional responsible for administering the immunisation product.

Any additional free-text information about the immunisation