Conducting standard user testing (preparation and conducting pilot and main testing of the package insert in accordance with the requirements of the EAEU 88 Solutions in Kazakh and Russian)

In the procedure for registration of medicinal products in accordance with the EAEU rules, one of the requirements is to conduct user testing of the package leaflet (PL) in the national language in the Union country. As a rule, in the EAEU countries, the results of user testing (UT) are provided for the draft package leaflet, which in the event of adjustment of the package leaflet by the expert organization may lead to the need for repeated user testing.

The provision of user testing results in Kazakhstan is carried out according to a different algorithm — testing is carried out after the approval of the final version of the package leaflet according to the scheme below. This allows you to avoid additional costs for repeated testing, and in some cases reduce the overall time of the registration process. 90 working days are given for the approval and execution of user testing, provided in response to the expert’s request in XML format in the form of a response to the expert’s request.