Leaflet Readability Testing

Considering directive 2001/83/EC, amended by directive 2004/27/EC and legislations regulating pharmaceuticals marketing authorisation, with marketing authorisation application it should be submitted results to performed Package Leaflet readability testing or Bridging report.

JSC Sveikuva prepares the Package Leaflets and performs package leaflet testing for readability according EU legislation requirements and guidelines.

Testing methodology and consultations results systematization with patients allows us to prepare clear and understandable package leaflets, which contains easy findable information.

We perform PL readability testing since 2007. We performed hundreds orders which were successfully passed marketing authorisation procedures in Lithuania and other EU countries.

We are flexible, so we can propose solution which satisfies client’s specific needs at competitive terms.

JSC Sveikuva offers readability testing services:

  • Preparation of package leaflet in-line with CMD(h) guidelines
  • Elaboration of testing strategy.
    Identifying necessity of testing, patient groups, important information
  • Performing package leaflet readability testing
  • Preparation of bridging reports
  • Package leaflet translations

Leaflet Readability Testing

Considering directive 2001/83/EC, amended by directive 2004/27/EC and legislations regulating pharmaceuticals marketing authorisation, with marketing authorisation application it should be submitted results to performed Package Leaflet readability testing or Bridging report.

JSC Sveikuva prepares the Package Leaflets and performs package leaflet testing for readability according EU legislation requirements and guidelines.

Testing methodology and consultations results systematization with patients allows us to prepare clear and understandable package leaflets, which contains easy findable information.

We perform PL readability testing since 2007. We performed hundreds orders which were successfully passed marketing authorisation procedures in Lithuania and other EU countries.

We are flexible, so we can propose solution which satisfies client’s specific needs at competitive terms.

JSC Sveikuva offers readability testing services:

  • Preparation of package leaflet in-line with CMD(h) guidelines
  • Elaboration of testing strategy.
    Identifying necessity of testing, patient groups, important information
  • Performing package leaflet readability testing
  • Preparation of bridging reports
  • Package leaflet translations