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Assurances to accompany an OTC new medicine N2 application

Last updated

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

How to access a pdf or Word document

This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

Supporting documents

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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