Assurances to accompany an OTC new medicine N2 application
The completed assurances form is required in Module 1.5 of your OTC new medicine N2 application.
|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|
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.