Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Inclusion of the German purely national marketing authorisations in the scope of the Variations Regulation and use of the new Classification Guideline of 2013 in practice compared to the previous guideline and the former national German variation system ***

Dr. Klaus Löchner (Abschlußjahr: 2014)

Summary
Language: English
On 04.08.2013 the inclusion of the purely national marketing authorisations (MA) in the scope of Commission Regulation (EC) No 1234/2008, also known as ‘the Variations Regulation’, became effective together with the new, updated Classification Guideline of 16.05.2013. This thesis investigates the consequences of the related changes from an industrial point of view.
In a first step, the differences between the former and updated Classification Guideline were analysed. Secondly, differences between the former national German variation system and the European variation system as defined by the Variations Regulation and Classification Guideline were investigated. Subsequently, potential practical consequences of the differences found were drawn up. Lastly, in order to assess the potential consequences of the new regulatory situation, a survey was performed.
The new, updated Classification Guideline has been revised comprehensively and with due care. It contains an improved and comprehensive catalogue of change categories and it was amended with an opening clause for type II variations. This makes the use of the Classification Guideline easier and more convenient in practice. Nevertheless, there is still some room for improvement. For MA holders an increased awareness of the many positive aspects of the update would be beneficial in practical use.
Compared to the lean former national German variation system the European variation system is more laborious. Whereas for companies with many purely national MAs of identical medicinal products in different member states the use of the European variation system results in easier variation tracking and reduced workload, the benefits of the harmonisation do not take effect for companies, which hold mainly German purely national MAs. According to the survey, overall workload and costs increased and no time is saved by the MA holders.
In order to mitigate the consequences of the transition to the European variation system, the BfArM developed a sophisticated system of status mails and remarkably facilitated horizontal and vertical grouping of variations to purely national MAs. Furthermore, a first draft of the revised AMGKostV suggests the reduction of fees for national variations in Germany.
Beyond this, reduced fees for IB variations that require only very little assessment should be considered to encourage the submission of general updates of the dossier.
Some transitional problems have been resolved, others are still open. A slight optimisation like allowing simply more uploads in the PharmNet.Bund portal would save the applicants plenty of time and costs and would avoid workarounds.
As not all possible changes to a MA are covered by the Variations Regulation, notifications of change according to Section 29(1) AMG will still remain necessary. In this respect, the handling of non-variations (changes in labelling or PL outside of the SmPC) and the national notification of pack sizes already approved in MRP/DCP are internally still under discussion at the BfArM.
To further improve the European variation system, the positive approach of the BfArM in terms of variations to purely national MAs should serve as a model for other member states.
Pages: 82, Annexes: 24 pages