ISO 11616 pdf download – Health informatics一Identification of medicinal products一Data elements and structures for unique identification and exchange of regulated pharmaceutical product information.
— a PhPID has one or more active substances (cardinality relationship: 1..n);
— a PhPID has one or more active specified substances (cardiriality relationship: 1 .,n);
— a PHPID has one or more specifIed substances (cardinality relationship: 1..n);
— a PhPID has one strength (cardinality relationship: t..1) based on one to many active substances or specified substances (cardinality relationship: 1..n); for liquid preparations, the unit volume (cardinality relationship: 1..1) and total volume per container (cardiriality relationship: 1..1) shall both be represented:
— a PHPID has one reference strength (cardinality relationship: 1.1) but it can be composed from strength of one to many active substances or specified substances (cardinality relationship: l..i).
5.3 Representation of strength concentration
For liquid preperations. strength shall be represented by both the total volume of the container as authorized by a Regulatory Medicines Authority and strength concentration per unit volume (e.g. 1 ml). For PhPID generation arid assignment, the strength shall be expressed per total volume per container(MCID and PCID) with the corresponding strength concentration per unit volume represented n every instance oIPhPID Levels 2 and 4. Both representations shall be considered mandatory elements when illustrating the strength of a pharmaceutical product.
EXAMPLE It two products contavi the same strength per 1 ml, but with dilterent container volumes represented, (Product A at 25 mg/S ml and Product B at 50 mg/iC) ml), dilterent PhPIDs are assigned, edh the strength per unit volume o15 mg/ml represented wilhwi PSiPID levels 2 and 4,
The strength concentration per unit volume shall be calculated from the strength per total volume of the container and presented at all PhPID levels where strength is represented in accordance with the product authorization by a regulatory authonty.
The strength per unit volume shall be included as a data element and mapped to the strength per total volume at al applicable PhPID levels to support the interoperability and exchange of pharmaceutical product data.
The calculation and mapping of strength concentration per unit volume to the strength per total volume at all applicable PIiPID levels shall be addressed during implementation and maintenance of this International Standard,
5.4 Pharmaceutical product identifier (PhPID)
The PhPID Is a unique code assigned at the level of the pharmaceutical product and utilizes the identifying characteristics as outlined below. For products that need to be reconstituted in accordance with the authorization by a Regulatory Medicines Authority before they can be administered, the PhPID shall refer to the characteristics of the product after reconstitution.
NOTE A meconaI product may have two manufactured items, one with a manufactured dose form of powder and the oth with a manufactured dose form of “soivear. These are then reconstituted to an adminestrabte dose form SOkit.On for injection’ before bewig adnwnlstered to a patient.
5.6.3.1 AdminIstrable Dos. Form Term ID
The Admmistrablo Dose Fom, 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.
5.6.32 AdmInistrable Dose Form Term
The Adimnistrable Dose Form Term of the pharmaceutical product shall be speczfied on a value drawn from the value set as defined in ISO 11239. The standard term for the Administrable Dose Form (see ISO 11239) shall be described,
5.6.4 UnIt of presentation
Unit of presentation refers to the qualitative descriplion of the unit in which the strength(s) of the pharmaceutical product is presented and descflbed, often specifically at the point of delivery to the patient, in cases where a quantitative unit of measurement is not applicable. The unit 01 presentation standard term (see ISO 11239) shall be described.
EXAMPLE “Contains 100 mcg per spray” (uet 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.
ISO 11616 pdf download – Health informatics一Identification of medicinal products一Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
