Identification of the prescribed product. Section A1.4 of the eHN guideline

Brand name of the authorised medicinal product. It has to be noted, that according to Implementing Directive 2012/52/EU additional requirements may apply. [not applicable for generic prescriptions]

Identifier of a medicinal product refers to the product inside the package, not the packaged item as such. It could be MPID according to ISO 11615, EMA PMS ID and/or a national identifier. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Identifier of a pharmaceutical product refers to unique PhPID according to ISO 11616. This could be a part of a description of a specific medicinal product or an attribute of a generic prescription. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Identifier of a packaged medicinal product refers to a specific pack size of a specific product. It could be PCID according to ISO 11615 and/or its national equivalent. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Organisation that holds the marketing authorisation of the prescribed product. [not applicable for generic prescriptions]

All active substances according to ISO 11238. Referred to by ""common name"" in implementing directive 2012/52/EU.

• Preferred system(s): EMA SMS

Presentation and/or concentration strength of the active substances. In addition, reference strength could be provided (Article 1 of Directive 2001/83/EC).

• Preferred system(s): UCUM; EDQM

WHO ATC code of the product

• Preferred system(s): ATC

Dose form of a product could be either authorised dose form (includes EDQM combination pack dose forms), administrable dose form or manufactured item dose form. It must be made clear which type of dose forms are provided. For example, for the same product several different dose forms can be provided: ?powder and solvent for solution for injection? as authorised dose form, ?solution for injection? as administrable dose form, and ?powder? and ?solvent? as the dose forms for the manufactured items in the inner packaging. Referred to by ""pharmaceutical formulation"" in implementing directive 2012/52/EU.

• Preferred system(s): EDQM

Unit of presentation is used as a unit when describing the strength, but according to ISO IDMP it is also a separate attribute of the pharmaceutical product and manufactured item.

• Preferred system(s): EDQM

Type of the container, Examples: bottle, blister, box

• Preferred system(s): EDQM

Typically, the pack size is the number of unit of presentations in the package. It could also be presented using units of measurement (ml, g). In some cases, there is a need to refine the package size that it describes the amounts of different manufactured items in more than one inner packages. However, the overall amount of a prescribed product must be calculable from the pack size description.

• Preferred system(s): UCUM; EDQM

Identification of the prescribed product. Section A1.4 of the eHN guideline

Brand name of the authorised medicinal product. It has to be noted, that according to Implementing Directive 2012/52/EU additional requirements may apply. [not applicable for generic prescriptions]

Identifier of a medicinal product refers to the product inside the package, not the packaged item as such. It could be MPID according to ISO 11615, EMA PMS ID and/or a national identifier. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Identifier of a pharmaceutical product refers to unique PhPID according to ISO 11616. This could be a part of a description of a specific medicinal product or an attribute of a generic prescription. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Identifier of a packaged medicinal product refers to a specific pack size of a specific product. It could be PCID according to ISO 11615 and/or its national equivalent. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Organisation that holds the marketing authorisation of the prescribed product. [not applicable for generic prescriptions]

All active substances according to ISO 11238. Referred to by ""common name"" in implementing directive 2012/52/EU.

• Preferred system(s): EMA SMS

Presentation and/or concentration strength of the active substances. In addition, reference strength could be provided (Article 1 of Directive 2001/83/EC).

• Preferred system(s): UCUM; EDQM

WHO ATC code of the product

• Preferred system(s): ATC

Dose form of a product could be either authorised dose form (includes EDQM combination pack dose forms), administrable dose form or manufactured item dose form. It must be made clear which type of dose forms are provided. For example, for the same product several different dose forms can be provided: ?powder and solvent for solution for injection? as authorised dose form, ?solution for injection? as administrable dose form, and ?powder? and ?solvent? as the dose forms for the manufactured items in the inner packaging. Referred to by ""pharmaceutical formulation"" in implementing directive 2012/52/EU.

• Preferred system(s): EDQM

Unit of presentation is used as a unit when describing the strength, but according to ISO IDMP it is also a separate attribute of the pharmaceutical product and manufactured item.

• Preferred system(s): EDQM

Type of the container, Examples: bottle, blister, box

• Preferred system(s): EDQM

Typically, the pack size is the number of unit of presentations in the package. It could also be presented using units of measurement (ml, g). In some cases, there is a need to refine the package size that it describes the amounts of different manufactured items in more than one inner packages. However, the overall amount of a prescribed product must be calculable from the pack size description.

• Preferred system(s): UCUM; EDQM

Identification of the prescribed product. Section A1.4 of the eHN guideline

Brand name of the authorised medicinal product. It has to be noted, that according to Implementing Directive 2012/52/EU additional requirements may apply. [not applicable for generic prescriptions]

Identifier of a medicinal product refers to the product inside the package, not the packaged item as such. It could be MPID according to ISO 11615, EMA PMS ID and/or a national identifier. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Identifier of a pharmaceutical product refers to unique PhPID according to ISO 11616. This could be a part of a description of a specific medicinal product or an attribute of a generic prescription. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Identifier of a packaged medicinal product refers to a specific pack size of a specific product. It could be PCID according to ISO 11615 and/or its national equivalent. [not applicable for generic prescriptions]

• Preferred system(s): EMA PMS

Organisation that holds the marketing authorisation of the prescribed product. [not applicable for generic prescriptions]

All active substances according to ISO 11238. Referred to by ""common name"" in implementing directive 2012/52/EU.

• Preferred system(s): EMA SMS

Presentation and/or concentration strength of the active substances. In addition, reference strength could be provided (Article 1 of Directive 2001/83/EC).

• Preferred system(s): UCUM; EDQM

WHO ATC code of the product

• Preferred system(s): ATC

Dose form of a product could be either authorised dose form (includes EDQM combination pack dose forms), administrable dose form or manufactured item dose form. It must be made clear which type of dose forms are provided. For example, for the same product several different dose forms can be provided: ?powder and solvent for solution for injection? as authorised dose form, ?solution for injection? as administrable dose form, and ?powder? and ?solvent? as the dose forms for the manufactured items in the inner packaging. Referred to by ""pharmaceutical formulation"" in implementing directive 2012/52/EU.

• Preferred system(s): EDQM

Unit of presentation is used as a unit when describing the strength, but according to ISO IDMP it is also a separate attribute of the pharmaceutical product and manufactured item.

• Preferred system(s): EDQM

Type of the container, Examples: bottle, blister, box

• Preferred system(s): EDQM

Typically, the pack size is the number of unit of presentations in the package. It could also be presented using units of measurement (ml, g). In some cases, there is a need to refine the package size that it describes the amounts of different manufactured items in more than one inner packages. However, the overall amount of a prescribed product must be calculable from the pack size description.

• Preferred system(s): UCUM; EDQM