2025-07-03: DEUSG Virtual

Opening

2

@Shane Byrnes 
@Alejandro Lopez Osornio

Welcome & Notification of Recording

Substances Co-ordination

10

@Krista Lilly @Alejandro Lopez Osornio 

Updates on Substances Co-Ordination:

• Step 1: Substances in multiple extensions

• Step 2: Substances in one extension

  • Country self-review/first pass

  • Then, SI will review in scope

Hydration - Demonstrate Examples

35

@Yongsheng Gao 

@Guillermo Reynoso @Linda Bird (Unlicensed) 

Updates on development work in relation to hydration substances.

• SI Hydration subsumption.pdf

• Canada

Vaccine Substances

2

@Shane Byrnes 

For Information: WHO recommended flu vaccine antigen substances for 2025/2026 season (Northern Hemisphere) are now available in International Release

• 1366440009 Antigen of Influenza B virus B/Austria/1359417/2021 (B/Victoria lineage)-like virus strain (substance)

• 1366438004 Antigen of Influenza A virus A/Croatia/10136RV/2023 (H3N2)-like virus strain (substance)

• 1366437009 Antigen of Influenza A virus A/Victoria/4897/2022 (H1N1)pdm09-like virus strain (substance)

• 1366436000 Antigen of Influenza A virus A/District of Columbia/27/2023 (H3N2)-like virus strain (substance)

• 1366435001 Antigen of Influenza A virus A/Wisconsin/67/2022 (H1N1)pdm09-like virus strain (substance)

• 1366374009 Antigen of Influenza B virus B/Phuket/3073/2013 (B/Yamagata lineage)-like virus strain (substance)

Has Container Type

5

@Linda Bird (Unlicensed) 

Feedback on Canada plans to use the |Physical object| hierarchy (specifically < 398124009 |Drug container (physical object)|) for the range of the |Has container type| relationship

'Drug Therapy' v 'Administration of drug'

5

@Nicola Ingram 

Group feedback sought on 'Drug Therapy' versus 'Administration of Drug' on Discussion Forum

AOB

All

1. National Extension Model Guide: User query on FSNs and PTs for combination 'Packaged Clinical Drug'. How are countries approaching this?

Topic Backlog

• Hydration Subsumption

• Less Granular Clinical Drug

• Elemental Substances (Matt, AUS)

• Substances Co-ordination

  • Step 1: Substances in multiple extensions

  • 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)

• Group Input on Patch Strength Representation

• Dose Form Intended Site v Route of Administration (BEL)

• Drug extension MRCM attributes (CA, AUS)