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Interim guidance for the prequalification assessment of spatial emanator products

Interim guidance for the prequalification assessment of spatial emanator products


This interim guidance was developed to provide information to stakeholders on the necessary requirements for a complete prequalification dossier specifically for spatial emanators. Its aim is to establish baseline guidance for dossier requirements which are necessary to assess spatial emanator products for the purposes of prequalification, describe the data requirements for fulfilling each dossier module, and provide information for applicants and testing facilities generating data for spatial emanator prequalification dossiers. The document is supported by implementation guidance documents which provide specific information and considerations for how applicants may approach the generation of supporting information and compilation of a complete product dossier.

This guidance is meant to be relied upon as an interim approach while a guideline is developed through the established procedures.  

Interim guidance for the prequalification assessment of spatial emanator products

Related to:

Document title:

Current version

Publication Date

Identification of changes

Parent guideline

Glossary of terms

August 2025

13/08/2025

1. Module 1

1.1 Module 1 Data Requirements Table

August 2025

13/08/2025

1.2 Module 1 Index

August 2025

13/08/2025

2. Module 2

2.1 Module 2 Data Requirements Table

August 2025

13/08/2025

2.2 Module 2 Index

August 2025

13/08/2025

2.3 IG - Product Summary

August 2025

13/08/2025

 

2.4 IG - Module 2 Summary of Quality Dossier Template

August 2025

13/08/2025

 

3. Module 3

3.1   Module 3 Data Requirements Table

August 2025

13/08/2025

3.2   Module 3 Index

August 2025

13/08/2025

3.3   IG - Declaration of product formulation

August 2025

13/08/2025

3.3.1 IG – Template DPF for spatial emanator products

August 2025

13/08/2025

3.4   IG – Product Manufacturing Details

August 2025

13/08/2025

 

3.4.1 IG – Template DMS

August 2025

13/08/2025

3.5   IG – Declaration of product sampling

August 2025

13/08/2025

 

3.6. IG – Emanation rate study

August 202513/08/2025 

3.7   IG – Storage Stability Study

August 2025

13/08/2025

 
3.8 IG – Template Manufacturing release specifications 

August 2025

13/08/2025

 

4. Module 4

4.1 Module 4 Data requirements table

August 2025

13/08/2025

 

4.2   Module 4 Index

August 2025

13/08/2025

 

5. Module 5

5.1 Module 5 Data requirements table

August 2025

13/08/2025

 

5.2   Module 5 Index

August 2025

13/08/2025

 

5.3   IG – Free-flight room studies

August 2025

13/08/2025

 

5.4   IG – Semi-field studies

August 2025

13/08/2025

 

5.5   IG – Strain selection

August 2025

13/08/2025

5.5.1 IG – MSMS

 

August 2025

13/08/2025

5.5.2 IG – Template MSMS

 

August 2025

13/08/2025

5.6   IG – Considerations for the selection of controls

August 2025

13/08/2025

6. Module 6

6.1   Module 6 Data requirements table

August 2025

13/08/2025

6.2   Module 6 Index

August 2025

13/08/2025

7. Module 7

7.1   Module 7 Data requirements table

Under development

7.2   Module 7 Index

Under development