head JofIMAB
Journal of IMAB - Annual Proceeding (Scientific Papers)
Publisher: Peytchinski Publishing Ltd.
ISSN: 1312-773X (Online)
Issue: 2021, vol. 27, issue1
Subject Area: Medicine
DOI: 10.5272/jimab.2021271.3598
Published online: 04 March 2021

Original article

J of IMAB. 2021 Jan-Mar;27(1):3598-3603
Krasimira ValchevaORCID logo Corresponding Autoremail,
Department of Public Administration, Faculty of Management and Administration, University of National and World Economy, Sofia, Bulgaria.

In the last few decades, the problem with falsified medicine became a global threat that accounts for millions of human lives and billions of financial loses for the national health authorities and pharmaceutical industry. Different measures were developed to fight their uncontrolled spread but had only limited success. The resolution that united the pharmaceutical supply chain actors worldwide is the introduction of track-and-trace systems, based on product serialization and verification. The European Union also adopted this solution, and its official operation began in 2019. Each Member State has specifics that have to be accounted for in the national transposition process and should influence the system design and functionalities. In Bulgaria, the responsible authorities seriously delayed to adopt an adequate legal and regulatory framework to support its smooth operation. This created many problems for some of the key supply chain participants – the wholesalers. Since the European system is not a full track-and-trace solution, their role in the verification process is limited and left to the national authorities to decide how to regulate it. At present, more than one year after the launch of the system, the national bylaws that should regulate their activities with reference to the European policy are still not enforced. The wholesalers are left to align their operations in a regulatory vacuum that may compromise the effectiveness of the policy and lead to sanctions for noncompliance.

Keywords: falsified medicines, pharmaceutical regulation, verification system, pharmaceutical wholesaler,

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Please cite this article as: Valcheva K. The Impact of the European Directive Against Falsified Medicines on the Pharmaceutical Wholesalers in Bulgaria. J of IMAB. 2021 Jan-Mar;27(1):3598-3603. DOI: 10.5272/jimab.2021271.3598

Corresponding AutorCorrespondence to: Krasimira Valcheva, Department of Public Administration, Faculty of Management and Administration, University of National and World Economy, Sofia; Student Town, 1700 Sofia, Bulgaria; E-mail: kvalcheva@unwe.bg

1. Nayyar GML, Breman JG, Herrington JE. The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives. Am J Trop Med Hyg. 2015 Jun;92(6 Suppl):2-7. [PubMed] [Crossref]
2. Behner P, Hecht ML, Wahl F. Fighting counterfeit pharmaceuticals: New defenses for an underestimated and growing menace. Strategy&PwC. June 29 2017. [Internet]
3. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. [Internet]
4. Valkov A. [Strategic Management of Healthcare Organizations. The Customer-driven Healthcare Management]. Avangard Prima. 2010. pp.28-32. [in Bulgarian]
5. Bulgarian Medicines Verification Organization.  Press conference "Official start of the medicine verification system in Bulgaria". February 6, 2019. [Internet]
6. Van Baelen M, Dylst P, Lopes Pereira C, Verhaeghe J, Nauwelaerts K, Lyddon S. Fighting Counterfeit Medicines in Europe: The Effect on Access to Medicines. Medicine Access@Point of Care. June 28, 2017. [Crossref]
7. Bozukova M. [The authorities are aware of two cases of falsified medicines in the pharmacies.] [in Bulgarian]  Mediapool.bg. January 16, 2019. [Internet]
8. Nikolova D. [Bulgaria does not monitor falsified medicines because it is expensive.] [in Bulgarian] Capital.  January 18, 2019. [Internet]
9. Lavelle K. Europe Fights Back against Counterfeit Medication with the European Falsified Medicines Directive. Peak- Ryzex Direct. April 22, 2016. [Internet]
10. Paunova I. The Bulgarian Medicines Verification System Goes Live. Bulgarian Medicines Verification Organization. April 18, 2018. [Internet]
11. Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance). [Internet]
12. Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance).
13. Bozukova M. [One-third of the drugs are scanned for falsification when dispensed.] [in Bulgarian] Mediapool.bg. February 14, 2020. [Internet].

Received: 01 April 2020
Published online: 04 March 2021

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