Masterarbeit

The Maghrebian Region – current situation and regulatory framework concerning marketing authorization process in comparison with Europe - Could a centralized System for the Maghreb be built?

Mohamed Akram Maaouia (2020)

Summary
Language: English
In this thesis, the legal environment influencing the marketing authorization process in the European Union and the countries of the Maghreb region (Tunisia, Morocco and Algeria) was identified and the different levels of legislation were presented.
There is no global procedure in the Maghreb region, nor is there a harmonized process between Tunisia, Morocco, and Algeria; nevertheless, these countries share many similarities, in most cases following the standards of the European Union. In this context, the processes in the European Union and in the three Maghreb countries respectively were presented in detail.
Tunisia, Morocco, and Algeria have special needs. The assessment process and the organization of the competent authorities are very similar. If we delve into the details, some differences will be recognized, particularly with regard to the administrative part. This is mainly due to technical limitations. However, the application for marketing authorization and the evaluation process have a lot in common, which makes the development of a harmonized process in theory possible but nevertheless challenging. In this context, the potential advantages of a centralization were discussed.
The Maghreb countries should decide whether it is practically possible to develop a harmonized process and perhaps take the European Union's review and application processes as a model.
Pages: 49