User testing of Patient leaflet

This service is provided by ARS in accordance with the Decision of the Council of the Eurasian Economic Commission of November 3, 2016 N 88 "On the Adoption of the Requirements for the Medication Guide and Summary of Product Characteristics of medicinal products for human use."

User testing or justification of its absence is mandatory in accordance with the Decision of the Council of the Eurasian Economic Commission of November 3, 2016 N 78 "On the Rules for the registration and examination of medicines for medical use" (Appendix 16).

User testing demonstrates how the patient leaflet works in practice, identifies barriers that reduce the ability of people to understand and use the information presented, and also open up problem areas that require adjustment.

The patient leaflet user testing includes the following steps:

  1. User testing protocol development
  2. Selection and training of the interviewer
  3. Recruitment of the target participants
  4. Pilot testing
  5. Review of pilot test results and making changes to the test protocol of the patient leaflet
  6. Conducting the main testing phase
  7. Processing of the user testing results
  8. Drawing up a report on the results of user testing, including but not limited to:
  • Brief description of the dosage form
  • Brief description of the conducted testing 
  • Used questionary and feedback forms
  • Original and revised Patient leaflet
  • Brief description and discussion of test results
  • Resulting deduction

Each of these steps includes a set of necessary aspects and regulatory requirements. A user testing report must be attached to the registration dossier for examination.