The Falsified Medicines Directive and Legal Guarantees to Ensure Authenticity of Medicines. The Impact of Drug Serialization on Medicine Safety in the EU

• Autorzy: Marek Stych
• Języki publikacji: EN

Abstrakty

EN

The aim of this study is to present the impact of the new legal solutions introduced in the so-called Falsified Medicines Directive on medicine safety in the EU. For the purposes of this study, it was necessary to analyze and interpret the provisions of the said Directive and the Delegated Regulation. The guarantees of medicine authenticity, such as a code to be scanned and placed on the medicine packaging (serialization) have been discussed in the paper. These activities are aimed at reducing the market of counterfeit medicines across the EU. The research tool used in the study was the dogmatic and legal method, which made it possible to conclude, that the provisions of the Falsified Medicines Directive increase the guarantee of drug safety. Considering the fact that these regulations are apolitical, one can assume that they will be implemented in other legal systems. (original abstract)

Słowa kluczowe

EN

Medicine; Medications; Pharmaceutical law

PL

Medycyna; Leki; Prawo farmaceutyczne

• Czasopismo: Zeszyty Naukowe. Organizacja i Zarządzanie / Politechnika Śląska
• Rocznik: 2019
• Numer: z. 139 Competitiveness and Development of Regions in the Context of European Integration and Globalization. State - Trends - Strategies
• Strony: 551--558

Twórcy

autor

Marek Stych

• Pedagogical University in Krakow

Bibliografia

• 1. Commission Delegated Regulation (EU) 2016/161 of October 2, 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 (OJ L 32/1, 09.02.2016).
• 2. Directive 2011/62/EU of the European Parliament and of the Council of June 8, 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 (OJ L 174/74, 01.07.2011),
• 3. Fijałek, Z., Sarna, K. (2009). Fałszowanie leków i inne przestępstwa farmaceutyczne [Falsification of medicines and other pharmaceutical crimes]. Problemy Kryminalistyki, 263, 5-11.
• 4. Hamilton, W.L., Doyle, C., Halliwell-Ewen, M., Lambert, G. (2016). Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies. Health Policy and Planning, 10(31), 1448-1466.
• 5. Kovacs, S., Hawes, S.E., Maley, S.N., Mosites, E., Wong, L., Stergachis, A. (2014). Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries. PLoS ONE, 9(3), e90601. https://doi.org/10.1371/journal.pone.0090601.
• 6. Maksim, I.K. (2017). Fałszowanie Produktów leczniczych - Uwagi na tle Kodeksu Karnego i regulacji poza kodeksowych [Falsification of medicinal products - comments on the Penal Code and other regulations]. Zeszyty Prawnicze, 17.2, 39-43.

Identyfikatory

DOI

10.29119/1641-3466.2019.139.43