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Assurances to accompany an OTC new medicine N2 application

Provide the required assurances to support an OTC new medicine N2 application.

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The completed assurances form is required in Module 1.5 of your OTC new medicine N2 application.

Version history

VersionDescription of changeAuthorEffective date
V1.0Original publicationCOMB - Over the Counter Medicine Evaluation Section25 July 2014
V2.0Reformatted and updated assurances regarding TSE and preservative efficacyCOMB - Over the Counter Medicine Evaluation Section30 November 2015
V3.0New template
Updated hyperlinks
Minor edits
Added reference to TGO 92
Reference to CPMP/QWP/2054/03 updated to EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1
Reference to CPMP/ICH/283/95 updated to ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr.*
Reference to TGO 80 updated to TGO 95
Title of Ph. Eur. Monograph 2.9.27 updated		COMB - Over the Counter Medicine Evaluation SectionFebruary 2026

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Page history

Show all page updates (1)
  • New template
  • Updated hyperlinks
  • Minor edits
  • Added reference to TGO 92
  • Reference to CPMP/QWP/2054/03 updated to EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1
  • Reference to CPMP/ICH/283/95 updated to ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr.*
  • Reference to TGO 80 updated to TGO 95
  • Title of Ph. Eur. Monograph 2.9.27 updated
  • New template
  • Updated hyperlinks
  • Minor edits
  • Added reference to TGO 92
  • Reference to CPMP/QWP/2054/03 updated to EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1
  • Reference to CPMP/ICH/283/95 updated to ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr.*
  • Reference to TGO 80 updated to TGO 95
  • Title of Ph. Eur. Monograph 2.9.27 updated