Masterarbeit
Regulatory Considerations regarding Multilingual Labelling in the EU
Dr. Felicitas Wendling (2020)
Summary
Language: English
Outer and immediate labelling contributes substantially to the unambiguous identification of a medicinal product. In addition, labelling is designed to give adequate directions to patients and healthcare professionals and to communicate benefit-risk information accurately and up-to-date.
The first subparagraph of Article 63(1) of Directive 2001/83/EC states that labelling must be in an official language of the member state in which it is to be marketed. Nonetheless, according to the second subparagraph of the same article, it is explicitly allowed to display the required particulars in several languages - provided that the same information appears in all languages used.
Multilingual labelling is pursued by marketing authorisation holders for various reasons, for instance, due to several official languages in one member state or voluntarily as it may provide more flexibility and the chance of supplying medicinal products in small markets. Furthermore, there may be a possible reduction in costs.
This thesis aims to present the numerous regulatory challenges involved in the creation and maintenance of multilingual labelling. The regulatory framework based on Directive 2001/83/EC, exemplary national regulations and guidance documents regarding multilin-gual labelling in the EU are compiled. Furthermore, already established joint assessment concepts, like the Nordic or Baltic Package, are presented. Also, an overview of how the situation is handled in exemplary multilingual member states is given.
While multilingual packages are already used successfully in various combinations, the thesis demonstrates that there still is room for further improvement. More pragmatic re-quirements and greater harmonisation within the member states could lead to broader use of common packaging. Especially considering the existing supply shortages, multilingual and also foreign language labelling may contribute to an improvement of these problems.
Pages: 90
Annexes: 6, Pages: 4