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How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia

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Abstract

The primary role of European pharmaceutical legislation is to safeguard public health while encouraging the development of the pharmaceutical industry, creation of single market for pharmaceuticals with removed barriers to medicines trade. This article presents some important characteristics of pharmaceutical legislation in Serbia, the potential EU candidate country, and the latest improvements of existing national pharmaceutical legislation. Additional explanation is given for the Serbian negotiations with World Trade Organization and measures taken for the harmonisation with Agreements on Technical barriers to Trade (TBT), especially with Agreement on Trade-Related Intellectual Property Rights. Current status of Serbian pharmaceutical market is described, with the highlight of domestic manufacturers’ capacity to comply with European Union requirements. National medicines agency is described in the framework of European medicines quality infrastructure. The role and responsibility of national medicines authority to assure access to quality, safe and efficacious medicines on Serbian market is described. The special emphasis is given to agency’s role in harmonisation process, in terms of removing unnecessary barriers to medicines trade in Serbia.

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Conflict of interest

Authors are declaring no conflict of interest, since this research is not sponsored and there are no personal commitments for either author.

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Authors and Affiliations

  1. Medicines and Medical Devices Agency of Serbia, Department for Quality Management, Faculty of Organizational Science, University of Belgrade, 458 Vojvode Stepe Street, 11152, Belgrade, Serbia

    Gordana Pejović

  2. Department for Quality Management, Faculty of Organizational Science, University of Belgrade, 154, Jove Ilica Street, 11040, Belgrade, Serbia

    Jovan Filipović

  3. Department for Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, 450, Vojvode Stepe Street, 11152, Belgrade, Serbia

    Ljiljana Tasić

Authors
  1. Gordana Pejović
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  2. Jovan Filipović
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  3. Ljiljana Tasić
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Correspondence to Gordana Pejović.

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Pejović, G., Filipović, J. & Tasić, L. How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia. Accred Qual Assur 16, 253–261 (2011). https://doi.org/10.1007/s00769-010-0749-7

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  • DOI: https://doi.org/10.1007/s00769-010-0749-7

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