Masterarbeit
EudraVigilance Medicinal Product Dictionary - a challenge for authorities and marketing authorisation holders
Christian Biegel (2012)
Summary
On 31st December 2010 the new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) entered into force which was the biggest change in the regulation for medicinal products for humans.
The first part of this thesis describes the legal background for the implementation of the EudraVigilance Medicinal Product Dictionary which is connected to a legal deadline. For better understanding also the changes regarding the new pharmacovigilance legislation in comparison to the existing legislation are described.
As the EudraVigilance Medicinal Product Dictionary is one part of the EudraVigilance Database Management System the second part gives a short overview over the structures, modules and scope of EudraVigilance.
The third part includes the four phases of the implementation of the EudraVigilance Medicinal Product Dictionary. These four phases can be understood as the implementation plan of the EMA to meet the legal deadline of 2nd July 2012. At this time point the new database has to include all authorized medicinal products across Europe. In phase one the EMA has to define the submission format for the necessary data, in phase two the submission of the requested data is performer by the marketing authorisation holders. Phase 3 is the processing and validation of the submitted information and phase 4 is the migration of the format in compliance with the ISO IDMP standard.
During implementation of the EudraVigilance Medicinal Product Dictionary the European Medicines Agency as well as the marketing authorisation holders were confronted with several challenges and problems, which is described in part 4 of this thesis. It is also an overview of the initial time plan as well as the realistic progress of the project characterized.
In the last part of this thesis an overall conclusion is given as well as a critical discussion on the implementation of such a huge project limited by a relative short time frame.