Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Republic of Serbia on its way into the European Union? Review of regulatory preparation, discussion of challenges and future prospects for registration procedures of medicinal products

Doreen Stoof (Abschlußjahr: 2017)

Summary
Language: English
The Republic of Serbia has been a candidate country of the European Union since 2012. Already prior to the granting of candidate status, the EU started supportive measures for Serbia, including development of the pharmaceutical legislation. An analysis of the historical development of pharmaceutical legislation in Serbia reveals that it has been EU based since 2004. This was supported by cooperation with European regulatory agencies for medicines and medical devices, training and financial support by the Instrument for Pre-Accession Assistance (IPA). Especially the twinning programme between 2006 and 2009 with the French National Agency for Medicines and Health Products Safety (ANSM) led to the creation of several guidelines for Serbia. However, the support and development is not limited to assistance and training. Serbia is already a member of the European Pharmacopeia and General European Official Medicines Control Laboratory Network (GEON) and consequently participates in the formulation of EU requirements. Nevertheless, the pharmaceutical legislation, requirements and procedures are not yet completely harmonised.
The master thesis aims to analyse the status of adaptation of Serbian legislation to EU legislation, to illustrate the deficits, to discuss the consequences and to give recommendations related to further steps towards EU accession.
In order to analyse the status of this adaptation, the Law on Medicinal Products and Medical Devices, containing the basic information and subordinated regulations related to the details of specific topics, was examined. Analysis of the detailed information on the requirements and specifics of the marketing authorisation application, renewal and variation applications in Serbia demonstrates the conformities and shows that Serbia is already close to the EU requirements. However, there are still differences to EU legislation, such as the lacking implementation of type IA variations, annual reports or the granting of unlimited marketing authorisations after renewal, which shows that the Serbian agency is still struggling to implement all European procedures and requirements in full.
Further progress in cooperation with the EU could be the introduction of the nCADREAC procedure (new Collaboration Agreement of Drug Regulatory Authorities in Central and Eastern European Countries). This voluntary procedure was applicable in other candidate countries such as Bulgaria, Romania and Croatia to ease the application for already authorised EU products and to reduce the workload after EU accession. Comparison between the Serbian requirements and the nCADREAC requirements shows the analogy especially for variation procedures. However, Serbia has not yet signed the agreement or implemented the nCADREAC procedure.
Pages: 71;  Annexes 2, pages: 110