Leaflet Readability Testing

Considering Directive 2001/83/EC, amended by Directive 2004/27/EC and legislations regulating Marketing Authorisation of Pharmaceuticals, with Marketing Authorisation Application, the results of performed Package Leaflet (PL) readability testing or Bridging report should be submitted.

Sveikuva prepares Package Leaflets and performs Package Leaflet testing for readability according to EU legislation and guidelines.

Testing methodology and systematization of patient consultations’ results allow us to prepare clear and understandable Package Leaflets, which contains easily accessible information.

We perform PL readability testing since 2007. We have already performed hundreds of orders which 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.

Sveikuva offers Readability Testing services:

  • Preparation of Package Leaflet to be in-line with CMD(h) guidelines
  • Elaboration of testing strategy
    Identifying
  • Performing Readability Testing of Package Leaflet
  • Preparation of Bridging Report
  • Translation of Package Leaflet

 

Leaflet Readability Testing

Considering Directive 2001/83/EC, amended by Directive 2004/27/EC and legislations regulating Marketing Authorisation of Pharmaceuticals, with Marketing Authorisation Application, the results of performed Package Leaflet (PL) readability testing or Bridging report should be submitted.

Sveikuva prepares Package Leaflets and performs Package Leaflet testing for readability according to EU legislation and guidelines.

Testing methodology and systematization of patient consultations’ results allow us to prepare clear and understandable Package Leaflets, which contains easily accessible information.

We perform PL readability testing since 2007. We have already performed hundreds of orders which 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.

Sveikuva offers Readability Testing services:

  • Preparation of Package Leaflet to be in-line with CMD(h) guidelines
  • Elaboration of testing strategy
    Identifying
  • Performing Readability Testing of Package Leaflet
  • Preparation of Bridging Report
  • Translation of Package Leaflet