In the registration procedure for medicinal products in accordance with the EAEU rules, one of the requirements is to conduct Product Information Leaflet (PIL) Readability User Testing (RUT) in the national language in the country of the Union. As a rule, in the EAEU countries the results of PIL RUT are provided for the draft PIL, which, if the PIL is corrected by the regulator, 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 conducted after the final version of the PIL has been approved upon according to the diagram below. This allows pharmaceutical companies to avoid additional costs for re-testing, and in some cases reduce the overall time of the registration process. The PIL RUT is given 90 working days to agree and execute, provided with an XML-based response to the expert’s request.

Process scheme in Kazakhstan:

Inpharmatis Group is one of the leading experts in conducting PIL RUT according to the EAEU in Russia, Belarus, and Kazakhstan (including in the Kazakh language). More than a hundred successful PIL RUTs have been carried out for many pharmaceutical companies in the EAEU, CIS and EU countries, as well as for leading international manufacturers.

PIL RUT with Inpharmatis is a focus on the Client’s needs, a separate team of experts and experienced interviewers, optimal timing and flexible prices.

For more information, please contact us: info@inpharmatis.com.

Article author
Arshat Kadrushev,
Regulatory Affairs Specialist
Inpharmatis