Valentina Ciurlia -

For all medicinal products registered in Italy via national procedure, the Marketing Authorization Holder is requested to submit within December 1st, 2015 a variation to update the dossier including the results of the readability test or proper justifications for not presenting it.

The Readability User Test is a consultation with target patient groups which aims to ensure that the Patient Leaflet is easily legible, clear and easy to understand, in order to let the use of the medicinal product to be appropriate and safe.

The first step of this activity is the adaptation of the Patient Leaflet according to the last version of Working Group of Quality Review of Documents Template.

The PL to be used for the subsequent step should have the same graphical characteristics of the one that will be on the market.

The user test consists in a face-to-face interview based on questionnaires and is carried out through the following steps:

  • Pilot Test: three professionals familiar with the guidelines of the Readability User Test are tested in order to check if the PL content is clear and easy to understand and if the questionnaire is able to work in practice and elicit the expected answers.
  • User Test: at least 20 people, divided into 2 subsequent runs of 10 people each, are interviewed.

During each step, the PL may be subject to amendments on the basis of eventual suggestions by the testers, in order to obtain the final PL.

As an alternative to the Full Readability User Test, it is possible to carry out a Bridging study in which a successful User Test conducted on one PL (“parent” PL) can be used to support a justification for not testing other leaflets (“daughter” PLs); this type of study can take place only if these PLs have sufficiently similar characteristics in terms of content, design and layout.

Several exemptions for the submission to Readability Test or Bridging study are also foreseen.

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