Summary

Language: English

All medicinal products are required by Article 54, Article 55 and Article 59 of Directive 2001/83/EC to be accompanied by outer/inner labelling text and a package leaflet setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use their medicine safely and appropriately [...].
Article 63(2) of Directive 2001/83/EC also requires that the package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals [...].
Article 59(3) of Directive 2001/83/EC provides that the package leaflet shall reflect the results of consultations with target patient groups to ensure the requirements of Article 63(2) are met.

It is of paramount importance to define the key (safety) information of medicinal products upfront for the conduction of target populations consultations. A definition of "key (safety) information" is paraphrased in a complex way and spread over many text passages in several legal guidance documents, but no compiled definition is given.

This master thesis investigates on the importance of "key (safety) information" for the submission of readability user testings via a questionnaire sent out to approximately 200 colleagues working in Regulatory Affairs throughout Europe. It evaluates the background information on regulatory submissions of readability user testings and studies how colleagues define the expression "key (safety) information" in their daily regulatory practice. Additionally, the master thesis investigates on further importance of this term with regard to current ongoing discussions in the regulatory environment.
 

It elaborates a definition of the term "key (safety) information" considering both the results from the questionnaire and the available guidance documents. Furthermore, recommendations for the pharmaceutical industry how to handle "key (safety) information" in readability user testing appropriately are given.

Pages: 69, Annexes: 3, pages: 22