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
TY - JOUR
AU - Pejović, Gordana
AU - Filipović, Jovan
AU - Tasić, Ljiljana
PY - 2011
UR - http://farfar.pharmacy.bg.ac.rs/handle/123456789/1520
AB - 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.
PB - Springer, New York
T2 - Accreditation and Quality Assurance
T1 - How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia
VL - 16
IS - 4-5
SP - 253
EP - 261
DO - 10.1007/s00769-010-0749-7
ER -
@article{
author = "Pejović, Gordana and Filipović, Jovan and Tasić, Ljiljana",
year = "2011",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/1520",
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.",
publisher = "Springer, New York",
journal = "Accreditation and Quality Assurance",
title = "How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia",
volume = "16",
number = "4-5",
pages = "253-261",
doi = "10.1007/s00769-010-0749-7"
}
Pejović, G., Filipović, J.,& Tasić, L. (2011). How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia.
Accreditation and Quality Assurance
Springer, New York., 16(4-5), 253-261.
https://doi.org/10.1007/s00769-010-0749-7
Pejović G, Filipović J, Tasić L. How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia. Accreditation and Quality Assurance. 2011;16(4-5):253-261
Pejović Gordana, Filipović Jovan, Tasić Ljiljana, "How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia" Accreditation and Quality Assurance, 16, no. 4-5 (2011):253-261,
https://doi.org/10.1007/s00769-010-0749-7 .
