ISO 11616:2012 pdf download – Health informatics ldentification ofmedicinal products -Data elements andstructures for unique identification and exchange of regulated pharmaceutical product information.
5.6.2.12 Specified Substance Term
The Specified Substance Term of the pharmaceutical product shall be specified on a value drawn from the value set as defined in ISO 11238. The standard term for the Specified Substance (see ISO 11238) shall be described.
5.6.2.2 Role
The role that the substance plays in the product shall be specified, for instance acUve ingredient, adjuvant.
5.6.3 Administrable dose form
This describes the pharmaceutical dose form to be administered in accordance with the terms as authorized by a Regulatory Medicines Authority, after it has undergone any necessary reconstitution. It is a value drawn from a value set specified in ISO 11239. It is to be specified using a CD data type.
EXAMPLES Tablet, capsule, oral solution, suspension. Each pharrnaceubcal product has only one pharmaceutical form,
NOTE A medicinal product may have two manufactured items, one with a manufactured dose form of powder and the other with a manufactured dose form of soivent, These are then reconstituted to an administrable dose form solution for lnectio& before being adminetered to a paben4
5.6.3.1 Administrable Dose Form T.rm4D
The Administrable Dose Form Term-ID of the pharmaceutical product shall be specified on a value drawn from the value set as defined in ISO 11239. The standard term identifier for the administrable dose form (see ISO 11239) shall be described
5.8.3.2 Administrable Dose Form Term
The Administrable Dose Form Term of the pharmaceutical product shall be specified on a value drawn from the value set as defined in ISO 11239. The standard term for the Administrable Dose Fom, (see ISO 11239) shall be describod,
5.6.4 Unit of presentation
Unit of presentation refers to the qualitative description of the unit in which the strength(s) of the pharmaceutical product is presented and described, often specifically at the point of delivery to the patient, in cases where a quantitative unit of measurement is not applicable The unit of presentation standard term (see ISO 11239) shall be described.
EXAMPLE Contains 100 mog per spray (unit of presentation = spray).
5.6.4.1 UnIt of Presentation T.rm-ID
The Unit of Presentation Term-ID of the pharmaceutical product shall be specified on a value drawn from the value set as defined in ISO 11239. The standard term identifier for the Unit of Presentation (see ISO 11239) shall be described.
5.6.4.2 Unit of Presentation Term
The Unit of Presentation Term of the pharmaceutical product shall be specified on a value drawn from the value
set as defined in ISO 11239. The standard term for the Unit of Presentation (see ISO 11239) shall be described.
5.6.5 Medical device
When a medical device is a component of a pharmaceutical product, the following data elements apply
5.6.5.1 Medical Device Term-ID
The ‘Medical Device Temi-ID’ of the pharmaceutical product shall be specified, when applicable, based on a value drawn from a defined value set. The UDI shall be descnbed based on an international reference terminology.
56.52 Medical Device Term
The Medical Device Term of the pharmaceutical product shall be specified, when applicable, based on a value drawn from a defined value set, The medical device term shall be described based on an international reference terminology.
5.7 identifying characteristics to express strength
5.7.1 Expressing strength
Depending on the practices in a region or country, the strength description shall be the content of the active substance/specified substance description expressed quantitatively (e.g. per dosage unit, per unit of volume or per unit of weight, according to the pharmaceutical form or unit of presentation).
For a medicinal product with a different dose form before and after reconstitution, the pharmaceutical product section shall describe the strength of the actual pharmaceutical product after reconstitution or dilution in accordance with the regulatory product information.
NOTE 1 PhPlDs shall not Include information related to dosing. The actual amount of product administered to a patient by a heahh cere provider or self-administration is outside the scope of this International Standard,
For some pharmaceutical products, the exact dose strength cannot be indicated and therefore needs to be expressed as a range e.g. as ‘nOt greater than or as ‘nOt less than a particular value.
The strength indicated for the pharmaceutical product shall be identical to the strength after reconstitution to the volume as authorized by a Regulatory Medicines Authority.
EXAMPLE 1 Docetaxel concentrate 20 mgIO,5 ml Including 1,5 ml solvent the dose form nd strength for the PhPID will be docetaxel solution br infection 20 mgf2 ml (10 mg/mI)
EXAMPLE 2 Abatacept powder for concentrate for solution for .nusiOri does not contain solvent. The dose form and strength after ddution is stated in the product labelling. wtiid shall be utilized se the dose form and strength of the PhPlD:
abatacept concentrate for solution for infusIon 25 mg/mt.
NOTE 2 A description of strength is Included Annex C.
5.7.2 Attributes for representation of strength in PhPID stratum elements
5.7.2.1 Strength (concentration).