Email this article 
Comparison of Kosovo pharmaceutical legislation to the requirements of the European Union
Abstract
Introduction: The importance of the pharmaceutical legislation of a country consists in establishing rules, laws, bylaws and decisions based on which the daily work takes place in health institutions in general and the pharmaceutical sector in particular. The structure of today's pharmaceutical legislation, in terms of drug laws, the scope of drug regulatory agencies, drug evaluation boards, quality control laboratories and drug information centers has evolved over time.
Aim: The purpose of this paper is to collect existing information related to the pharmaceutical sector and assess the pharmaceutical profile of Kosovo according to the WHO form. Comparing the pharmaceutical legislation of Kosovo with those of the EU, with the aim of identifying aspects which require harmonize with EU laws and directives, with the laws in force in Kosovo, as well as suggesting options for improvement.
Materials and Methods: The pharmaceutical legislation of the European Union, Kosovo, and Austrian have been used as materials. For the comparison of pharmaceutical legislation, we have done the analysis according to four dimensions: administrative elements, regulatory functions, technical elements and level of regulation. We have collected data through a standardized form for regulatory assessment developed by the WHO and through the method of studying the archive. The method of studying the archive has included the evaluation of relevant documentation and records, which includes laws, executive orders, reports of relevant authorities, economic, health and other state indicators, as well as reports of other studies in this field. In the study we used the comparative approach to achieve the comparison of inter-state experiences related to pharmaceutical legislation.
Conclusions: Relevant state institutions of Kosovo should be engaged in providing institutional reports related to data on the pharmaceutical sector, in order to institutionally complete the pharmaceutical profile of Kosovo, as required by the WHO.
Keywords: Pharmaceutical legislation, European Union, Kosovo, Comparison
Full Text:
PDFReferences
Sauwakon Ratanawijitrasin, Eshetu Wondemagegnehu. Effective Drug Regulation: A multicountry study. World Health Organization 2002.)
Howells S. World Health Organization: international workshop on counterfeit drugs, Geneva, 26-28 November 1997 (abstract). (Document WHO/DRS/CFD/98.1).
Adams C. FDA launches probe of drugs from overseas. Wall Street journal, 12 September 2000.).
World Health Organization. Effective drug regulation: what can countries do?(discussion paper). Geneva, WHO Essential Drugs and Medicines Programme, 1999 (Document WHO/HTP/EDM/MAC(11)/99.6).
Geiling E, Cannon P. Pathogenic effects of elixir of sulfanilamide (diethylene glycol) poisoning. A clinical and experimental correlation. Final report. Journal of the American Medical Association, 1938, 111:919-926.
Dukes G. The effects of drug regulation: a survey based on the European studies of drug regulation. Lancaster, MTP Press Ltd., 1985.
O’Brien KL et al. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. Journal of the American Medical Association, 1998, 279(15):1175-78.
Singh J et al. Diethylene glycol poisoning in Gurgaon, India, 1998. Bulletin of the World Health Organization, 2001, 79(2):88-95.
Fake meningitis vaccine in Niger (editorial). Scrip, 23 August 1996, 2157:12.
http://apps.who.int/medicinedocs/en/d/Js2300e/17.html).
REKOS2011 - Census preliminary results.
Enti i Statistikave i Kosovës, 2011
IMF, 2010 projection
CIA World Factbook - Unless otherwise noted, information in this page is accurate as of July 12, 2011
PERINATAL SITUATION IN KOSOVO FOR YEARS 2000 – 2004
UNICEF. www.unicef.org/kosovo/children.html
KIS/IOM/UNFPA, 1999
SA = Statistics Austria
WHS – World Health Statistics
World Bank 2005, burimet MEF, LSMS 2000, HBS 2002; MTEF 2008-2010; MLGA
Calculated for the NHA (National Health Accounts), 2008
Aizhan Imasheva. Pharmaceutical sector of the Western Balkan countries. 2008 Annual Meeting & Exposition San Diego, CA October 25-29, 2008
Calculated for the NHA (National Health Accounts), 2007
Ministria e Shëndetësisë e Republikës së Kosovës. www.msh-ks.org/
2008 SPHS – Statistic Pharmacy Sector 2010
Agjencioni i Kosovës për Produkte Medicinale (AKPM). http://www.k-ma.org/
2008 WC – Written communication by Austrian Doctors’ Assocition
2008 PHIS – PHIS Hospital Pharma Report 2009
WHS – World Health Statistics
MSHP, Divizioni i Administrimit të pagesave dhe listpagesa e pagave. Marrë nga ESK 2008.
2010 WC – Written communication by Austrian Doctors’ Assocition
Agjencia e Akreditimit e Kosoves (AAK), MSH. 2011 www.akreditimi-ks.org/
Ruki Kondaj. Sfidat e Farmaceutikës. Toena. Tiranë, Shqipëri, 2010; fq. 129
Ruki Kondaj. Sfidat e Farmaceutikës. Toena. Tiranë, Shqipëri, 2010; fq. 130
Ruki Kondaj. Sfidat e Farmaceutikës. Toena. Tiranë, Shqipëri, 2010; fq. 31
Ruki Kondaj. Sfidat e Farmaceutikës. Toena. Tiranë, Shqipëri, 2010; fq. 139
Ruki Kondaj. Sfidat e Farmaceutikës. Toena. Tiranë, Shqipëri, 2010, fq. 116
DOI: http://dx.doi.org/10.52155/ijpsat.v33.1.4379
Refbacks
- There are currently no refbacks.
Copyright (c) 2022 Fitim Alidema, Flakron Alidema, Arieta Hasani Alidema, Mirzade Alidema Krasniqi
This work is licensed under a Creative Commons Attribution 4.0 International License.