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Discussion items

Item

Description

Mins

Owner

Notes & Actions

1Opening2

Welcome & Notification of Recording

2Substances Co-Ordination10Workshop/Clinic to support queries from countries currently undergoing reviews in advance of promotion. Policies related to substance submissions during this project.  Substances Co-ordination
3Implementation of Routes of Administration for medicines15

Update from New Zealand on Implementation of Routes of Administration

Presentation: 

4Editorial advice for PCDs PTs10

Consultation received from members about improving the guidance on this topic

5

Drug Administration vs Therapy

10

Highlight discussion topic

6AOB2Alejandro Lopez Osornio 

Prioritize backlog for next steps

Next meeting: August 7th, 2025

Antwerp 2025:

7Topic Backlog

  • Less Granular Clinical Drug
  • Elemental Substances (Matt, AUS)
  • Substances Co-ordination
    • Step 1: Substances in multiple extensions Batch promotions complete, SI review and authoring underway
    • Step 2: Substances in one extension
    • Step 3: Ongoing Substance Co-ordination (capturing at regulator level)
  • Medication Stopped v Medication Discontinued (Karen, SI)
  • Medicinal Product promotion co-ordination (Oslo group discussion as linked to substances work + ES)
  • Value range of a |Has container type| attribute (Linda, CA)
  • Top level children of 373873005 |Pharmaceutical / biologic product| hierarchy - are members using/how are members using? (AUS) 
  • Routes of Administration - Implementation Considerations (Mia, NZ)
  • Increase range of has active ingredient to include microorganisms and natural products (Guillermo)
  • Link between Substances and the organism they come from (Cat dander protein → Cat organism) see PCP-68


Done or in progress:

  • Hydration Subsumption 'Option 3' proposed by DEUSG for communication/consultation with MAG and EAG
  • Group Input on Patch Strength Representation Briefing note now being implemented
  • Dose Form Intended Site v Route of Administration (BEL) Pending implementation use-cases associated with intended site
  • Drug extension MRCM attributes (CA, AUS) SI facilitating links with CA and AUS for cross-promotion, next steps: other countries to be invited to add to catalogue
  • No labels