Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Evaluation of design and layout of folding boxes of centrally approved medicinal products using a decision matrix developed from legal requirements and available guidance documents ***

Svenja Seyler-Junker (Abschlußjahr: 2013)

Summary

Human medicinal products must be used safely and appropriate and medication errors must be avoided because they will cause a substantial threat to patient’s safety. Therefore the design of the immediate and outer packaging of medicines is very important and must guarantee a clear and unambiguous identification. Especially the critical information, like…., must be legible and easily accessible for the users so that they can understand and act according to this information. For non-prescription medicines this is particularly important as there is often no pharmacist´s advice reachable.
For this reason detailed legal requirements for labeling and European recommendations for the design process exist.
The objective of this thesis is to evaluate a number of different exemplary mock-ups with the help of above mentioned recommendations. They were read and assessed in terms of packaging design. A decision matrix was created containing just the points relevant for the overall layout and design of the folding boxes.
In total 19 mock-ups for different products were selected at random. The set could not be judged as representative one, but included prescription only and OTC products as well. The assessment demonstrated that lots of recommendations were not followed. Further on it could be identified that especially the presentation of the mock-ups was not satisfying. Therefore, proposals for the improvement of presentation of mock-ups were drawn up to support an easier review; arguments have been evaluated whether the decision matrix is a valuable tool to support Regulatory Affairs to assess compliance with regulatory requirements. Based on the practical experience it could be ascertained that it is a useful tool for Authorities to evaluate mock-ups.
In addition, MAHs must be given better advice how to present their mock-ups through improved guidelines and recommendations. These documents must be shortened, become more precise and should contain only the essential information. Furthermore, they should be better understandable, clearer and more practical. It would be also very helpful to harmonize and bring all the national recommendations together that exist apart from the European recommendations.

Pages:151, Annexes: pages: 94