OTC analytical validation summary form
If your application to register or change an OTC medicine requires Module 3 analytical validation data, we recommend that you complete an OTC analytical validation summary form for each critical assay or identification method before submitting your application. This will help you:
- Check that the analytical validation data is complete.
- Identify and rectify deficient validation data before submitting the application.
Completing the OTC analytical validation summary form
Complete a form for each critical assay or identification method, including assay of
- Active ingredients
- Related substances
If more than one analyte is determined by an individual method, a separate form needs to be completed for each analyte. For example, if a single HPLC method is used to determine the content of three active ingredients, three separate forms will need to be completed; one for each active ingredient.
Further guidance on the requirements for analytical validation data is located in the ARGOM Appendix 2: Guidelines on quality aspects in OTC medicines.
Submitting the OTC analytical validation summary form
We encourage you to submit the completed analytical summary form with your application as it can help us evaluate the data more efficiently.
If you choose to submit the form with your application;
- Take time to check you have accurately completed the form
- Include the form as an attachment to the application cover letter
- State in the cover letter that you have supplied the analytical validation summary form.
- OTC medicine evaluation - Analytical validation summary (pdf,94kb)
- OTC medicine evaluation - Analytical validation summary (Microsoft Word,135kb)
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||OMA/OTCME||29 June 2011|
The requirement to supply an analytical validation form whenever Module 3 is provided has been changed to optional.
Changed the location for the form from Module 1.5 of the dossier to an attachment to the cover letter.
|COMB/OTCMES||3 June 2016|