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The completed assurances form is required in Module 1.5 of your OTC new medicine N2 application.
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | COMB - Over the Counter Medicine Evaluation Section | 25 July 2014 |
| V2.0 | Reformatted and updated assurances regarding TSE and preservative efficacy | COMB - Over the Counter Medicine Evaluation Section | 30 November 2015 |
| V3.0 | 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 | COMB - Over the Counter Medicine Evaluation Section | February 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.