Olvashatósági teszt

glasses Readability tests should follow the below standards and guidelines:
  • 30/2005 (VIII. 2) Ministry of Health Decree
  • European Commission: Guideline on the readability of the labeling and package leaflet of medicinal products for human use. Revision 1, 12 January 2009. ENTR/F/2/SF/jr (2009)D/869
  • European Commission: Guidance concerning consultation with target groups for the package leaflet. May 2006
  • CMDh: Consultation with target patient groups - meeting the requirements of article 59(3) without the need for a full test - recommendations for bridging. Revision 1, April 2009. CMDh/100/2007

Readibility testing requires to perform interviews of at least 20 potential patients of a maximum of 45 minutes to assess the readability tests conducting proprietary formulations that are effective, patient prospectuses of the marketing authorization and the final sample approval, / interview extent, the leaflet content and extent dependent on a minimum of 10-15 issue occurs. Based on the interviews we compile the evaluation report and, if necessary, propose amendments to the MAH for a leaflet or co-operate in the official administration.

Based on the existing standards for pharmaceutical products as required in Hungary by 30/2005 (VIII. 2), the Minister of Health on medicinal products for human use, a label attached and package leaflet of the purpose of the leaflet finalize patients as the drug is indicated for target groups consulted (widespread unofficial designation readability test) must be conducted to ensure that the leaflet clearly legible, clear and easy to use. As a result of the need to reflect the package leaflet.

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