In the Regulation of the Minster of Health of 26 April 2010 on the leaflet readability test (in Polish: rozporządzenie w sprawie badania czytelności ulotki), Journal of Laws of 18 May 2010, No. 84, item 551, the Polish Minister of Health provided the principles of examination under which the content of the information attached to the pharmaceutical products is understandable.

The readability test of a pharmaceutical product’s leaflet is carried out by the responsible entity (an entrepreneur who applies for or has received the marketing authorization for a medicinal product), or any other person on its behalf, to ensure that a consumer understands the relevant information contained in this leaflet and will be able to correctly apply the medicinal product. The readability test should be conducted with the following minimum requirements:
– a leaflet should be in the version that will be attached to the packaging of a pharmaceutical product, or its color layout design,
– test participants are those who may use the medicinal product, including those who have difficulty understanding written information.

The test is carried out with ten participants. A positive test result means that for each question, 90% of study participants may find the information on a given leaflet, of which 90% may show their understanding and give the correct answer and to proceed with the medicinal product.

Categories: consumer protection law | pharmaceutical law | Polish Act on Pharmaceutical Law | product packaging | regulations.