Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Marketing Authorization transfer in the LATAM countries - Brazil, Mexico, Argentina, Colombia, Chile, Peru (major LATAM economies) and Panama, Guatemala, Costa Rica (SICA countries) & Venezuela

Spyros-Dimitrios Roussos (Abschlußjahr: 2022)

Summary
Language: English
The Marketing Authorization Transfer ("MAT") regards the transfer of the legal rights of the Marketing Authorization of a medicinal products from a successor company - "Transferor" to a successive company - "Transferee", after a legally binding transfer agreement between these companies takes place.
The Marketing Authorization Transfer is becoming nowadays a more and more common practice for pharmaceutical companies, who are multinational actors trying to expand their presence in the international economic stage by making mergers or acquiring me-dicinal products from other companies.
Within this Thesis is given an overview and a critical review of the Marketing Authoriza-tion Transfer procedure in the major LATAM countries from the point of view of market growth: Brazil, Mexico, Argentina, Colombia, Chile, Peru (major LATAM economies) and Panama, Guatemala, Costa Rica (SICA countries) & Venezuela for allopathic, synthetically manufactured medicinal products.
The Thesis starts providing with a detailed description of the core information related to the Marketing Authorization Transfer Application in each of the above LATAM countries.  This regards a description of the Legal Basis and the Regulatory Framework, the main Assembly requirements, the possible Submission ways, also referring to correlated pecu-liarities, the Review process and the Timelines up to the Implementation of the MAT, af-ter its approval.
It follows the discussion part, where the information provided at the beginning are re-viewed from a critical point of view. A comparison is made between the Review Timelines established within the regulation and the actual time necessary until approval get grant-ed. Furthermore, a comparison is also made to the several stages of the MAT procedure (from Submission to Implementation) among these LATAM countries, trying to point out the main differences and similarities to the process among these LATAM countries.   
Subsequently, the discussion is being extended referring to other regulatory activities, which must be taken into consideration when designing the MAT submission strategy, as they may have a serious impact in regard with the smooth outcome of the MAT proce-dure.
Finally, a critical comparison is made between the MAT procedure in the LATAM coun-tries versus the EU countries, pointing out the main differences between these two re-gions in this regard.
Pages: 74 / Annexes: 2, Pages: 7