OTC analytical validation summary form

3 June 2016

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
  • Preservatives

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.

Form

How to access a pdf or Word document

Version history

Version Description of change Author Effective date
V1.0 Original publication OMA/OTCME 29 June 2011
V1.1

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