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IDMP-ISO-11616

IDMP PhPID substance + form.

Definition

ISO 11616:2017 distinguishes 4 PhPID levels: Level 1 (substance), Level 2 (substance + strength), Level 3 (substance + strength + form), Level 4 (substance + strength + form + route). Cross-cutting reference grouping equivalent products (e.g. paracetamol 500mg tablet) across generics.

Origin

ISO 11616 published 2017 by ISO/TC 215.

Example in context

The PhPID L4 of paracetamol 500mg oral tablet aggregates ~150 medicinal products marketed worldwide.

Last updated: May 16, 2026