Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Sunset Clause in Germany – Provisions for nationally authorised human medicinal products under the responsibility of the Federal Institut for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)

Cora Bergmann (Abschlußjahr: 2015)

Summary
Language: English
The Sunset Clause (SSC) provision has been introduced by Directive 2004/27/EC, amending Directive 2001/83/EC, which has been transposed into the national laws of the European Member States by 30th October 2005 at the latest.
In Germany the provision of the SSC has been introduced in Section 31 of the Medicinal Products Act (Arzneimittelgesetz, AMG) by the 14th Law Amending the AMG dated 29th August 2005 which came into force on 06th September 2005.
This thesis takes a closer look at the implementation and interpretation of the SSC for nationally authorised human medicinal products under the responsibility of the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).
The legal basis, exemptions from the SSC and suspension of the 3-year period are discussed.
Further the obligation to notify the authorities regarding the marketing status of the medicinal products has been introduced by Directive 2004/27/EC and transposed into the national laws of the Member States. For conducting of these mandatory notifications and the tracking of the SSC, an online portal has been set up in Germany. The handling of this portal as well as the experiences made during the past years will be considered.
Pages: 60, Annexes: 3 (57 pages)