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Stated template view:
Gliffy Diagram size 1000 macroId 8513079c-bb49-4b15-b725-161249405857 displayName RCD Stated Template name RCD Stated Template pagePin 1
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Example: multiple active ingredient substance (presentation strength) branded product (Inegy): stated view followed by the inferred view
Figure 20: Multiple active ingredient substance (presentation strength) real clinical example stated view
Figure 21: Multiple active ingredient substance (presentation strength) real clinical example inferred view
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Figure 24: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug real clinical example stated view
Figure 25: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug real clinical example inferred view
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In this example, a concentration and presentation strength clinical drug has been NOT authored in the national extension and therefore the real clinical drug classifies under this the concentration strength concept in the international edition
Figure 26: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug real clinical example stated view
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In jurisdictions where repackaging and/or "parallel importing" are authorised, a national extension may wish to consider having a relationship between the repackaged or parallel imported real clinical drug and the real clinical drug supplied by the original manufacturer, if that is present within the jurisdiction.Product search systems and product matching systems using more detailed "name parts" may also be required.
IDMP Compatibility
For most authorised medicinal products, this class is roughly equivalent to the core Medicinal Product class, with its MPID identification in ISO 11615 of IDMP. However, the Medicinal Product class in IDMP explicitly includes combination (kit) products within it whereas this model describes combination products as packaged products only (see below). Implementation considerations may require combination products to be available to users alongside clinical drug and real clinical drug concepts; mechanisms such as the use of reference sets can support this requirement.
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