Package Leaflet Readability Test
All medicinal products which are placed on the market are required by the law to be accompanied by labelling and package leaflet which provide a set of comprehensible information enabling the Patient to use the medicinal product safely and appropriately.
In accordance with Article 59(3) of Directive 2001/83/EC, the package leaflet shall reflect the results of consultations with target Patient groups to ensure that it is legible, clear and easy to use.
What is Package Leaflet Readability Test?
As mentioned above and in reference to the Article 63(2) of Directive 2001/83/EC, the package leaflet must be written and designed in such a way as to be clear and understandable, enabling users to act appropriately (when necessary with the help of health professionals). Furthermore, the package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market.
The Package Leaflet Readability Test is a flexible tool that allows to determine whether the way the information is presented in the leaflet allows for its correct reception and understanding by appropriately selected test participants.
The test should be carried out using the same leaflet which will be attached to the medicinal product and in accordance with the existing graphic design (mock-up) of the leaflet.
Information regarding the ’user consultation’ performed together with the presentation of results must be included in section 1.3.4 of module 1 for all new applications and for relevant post-authorisation applications introducing significant changes to the package leaflet, e.g. OTC - switch. More information about it you can find in our article OTC status - what is it all about?
Stages of Package Leaflet Readability Test
The steps for testing the readability of the leaflet are as follows:
- Preparation of documents (questionnaire, randomization of questions, protocol, final leaflet mock-up/specimen).
- Recruitment of participants.
- Conducting a pilot phase.
- Conducting a Package Leaflet Readability Test.
- Readability Report Test preparation and submission to the appropriate Agency.
Take advantage of our experience
Support of experienced Experts in terms of Package Leaflet Readability Test – for who?
- for Marketing Authorisation Holders (MAHs) who want to submit registration dossier and need some help with Package Leaflet Readability Test conduction;
- for MAHs who need some help with Package Leaflet Readability Test conduction and Package Leaflet Readability Test Report preparation in any stage of product lifecycle.
Use our experience
Our Experts have extensive experience in Package Leaflet Readability Tests conduction and appropriate dossier preparation - all submitted Package Leaflet Readability Test Reports prepared by SciencePharma have been approved by European Agencies.
Pharmaceutical companies from all over the world have used our support many times and often come back to us.
Keeping abreast of the latest Competent Authorities requirements is much easier with the support of an experienced and well-informed team.
At SciencePharma, we offer:
- Package Leaflet Readability Test dossier preparation (Readability Test Protocol, Readability Test Questionnaire);
- Package Leaflet Readability Test conduction (consultation with target Patients groups);
- Package Leaflet Readability Test Report preparation (compilation of the results in form ready for submission).
Furthermore, we do have many years of experience with National, European and Centralised Procedures registration dossier submission, depending on the individual needs of the Marketing Authorization Holder.
If you are interested in working with us, please do not hesitate to contact us. Our Experts will answer all your questions and resolve the doubts.