Masterarbeit

New safety features against falsified medicines according to the Delegated Regulation (EU) 2016/161: Consequences for Parallel Distributors

Immanuel Weber (2016)

Summary
Language: English
The increase in the numbers of falsified medicines is a worldwide problem. The majority of falsified medicines are traded illegally over the internet, but also cases in the legal distribution chain were repeatedly observed. In some of these cases also parallel distributors were affected. This situation made it clear for all involved parties in the European Union, that new safety measures had to be introduced to further on guarantee safe medicines for the public.
The legislation, that finally introduced the details of the new measures, was the Commission Delegated Regulation (EU) 2016/161. On 9th February 2016, it was published and the implementation date for all stakeholders was set three years later for the 9th of February 2019. In the so-called “delegated act” primarily technical details about the unique identifier and the anti-tampering device as the new safety features were introduced.
The Unique Identifier as a unique code is imprinted in a 2D matrix code on each single pharmaceutical package. The storage, control and transfer of the data will be managed via a system of a central European server, connected to national repositories in the European Stakeholder Model. The system is designed as an end-to-end verification system which means that the manufacturer uploads and the point of dispense decommissions the unique identifier after the verification of the safety features. The second safety feature that needs to be verified at the point of dispense is the anti-tampering device. The device allows to identify manipulations at the original package and needs to be adequately replaced by the parallel distributor. Parallel distributers as part of the legal distribution chain are fully integrated into the use of the safety features. Their obligation is to verify the existing safety features and place their own unique identifier and anti-tampering device on each product before distribution.
Both safety features will make the legal distribution chain much safer than it is today. Beside this positive aspect, a lot of work and technical challenges are lying ahead for the stakeholders. The whole manufacturing processes has to be changed from a lot focused production to a single unit production, with all its implications. Like the original manufacturers, the parallel distributors will face significant investments and technical challenges during the implementation.
This master thesis intends to provide a brief overview about the current situation of falsified medicines in the European Union and wants to describe and discuss the changes that are introduced through the new "delegated act". A special focus will be on the current situation and its future consequences for parallel distributors.
Pages: 66, Annexes: pages : 4