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:

  User testing protocol development

  Selection and training of the interviewer

  Recruitment of the target participants

  Pilot testing

  Review of pilot test results and making changes to the test protocol of the patient leaflet

  Conducting the main testing phase

  Processing of the user testing results

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.

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