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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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2011
Authors
Pejović, Gordana
Filipović, Jovan
Tasić, Ljiljana
Article (Published version)
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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.

Keywords:
Medicines agency / Quality infrastructure / Barriers to trade / Access to medicines
Source:
Accreditation and Quality Assurance, 2011, 16, 4-5, 253-261
Publisher:
  • Springer, New York

DOI: 10.1007/s00769-010-0749-7

ISSN: 0949-1775

WoS: 000289112600011

Scopus: 2-s2.0-79953283878
[ Google Scholar ]
3
3
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/1520
Collections
  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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