20.500.12556/DKUM-93070 Pravni izzivi spletne prodaje in oglaševanja zdravil na spletu magistrsko delo Legal challenges in online sale and advertising of medicines Magistrska naloga se osredotoča na pravno ureditev spletne prodaje in oglaševanja zdravil na spletu v Republiki Sloveniji, Evropski uniji in Združenih državah Amerike. Cilj naloge je analizirati obstoječe pravne okvirje, oceniti njihovo učinkovitost ter izpostaviti ključne izzive in tveganja. Posebna pozornost je usmerjena tudi v ugotavljanje morebitnih vrzeli v zakonodaji ter predlogom za izboljšanje pravne regulacije na tem hitro razvijajočem področju. Vsestranska sodobna globalizacija vpliva, tako kot na številna druga področja, tudi na področje izdelave in trženja nezakonitih zdravil. Zaradi pomanjkanja ustreznih in natančnih predpisov so v številnih državah takšna zdravila lahko dostopna tudi v trafikah, drogerijah in predvsem na spletu, kar omogoča vprašljivim posameznikom dobiček. Preko spleta lažje ostanejo anonimni in v neurejenih pogojih proizvajajo neustrezna zdravila, ki škodujejo zdravju ali so celo smrtonosna. Družbeni in tehnološki razvoj, zlasti izjemna moč spleta, omogoča vsakemu posamezniku, da do neustreznih zdravil dostopa kar iz udobja doma. Široka dostopnost tovrstnih izdelkov ustvarja številne priložnosti za razvoj kriminala, ki jo je zaradi njenega mednarodnega značaja težko zaznati in učinkovito sankcionirati. Na podlagi primerjalno pravne analize lahko ugotovimo, da kljub obstoju regulativnih mehanizmov v vseh treh obravnavanih sistemih, v Evropski uniji s skupnim logotipom in obvezno registracijo, v Republiki Sloveniji z usklajenostjo z evropsko ureditvijo ter dodatnimi zahtevami Javne agencije za zdravila in medicinske pripomočke ter v Združenih državah Amerike s sistemom VIPPS in nadzorom Uprave za hrano in zdravila, ostajajo številni skupni izzivi. Med najpomembnejšimi so nezadosten nadzor nad čezmejno spletno prodajo, neustrezne sankcije, pomanjkljiva ozaveščenost kupcev zdravil ter dejstvo, da pravna ureditev pogosto ne sledi hitremu razvoju digitalne tehnologije. The master's thesis focuses on the legal regulation of online sales and advertising of medicines in the Republic of Slovenia, the European Union, and the United States of America. The aim of the thesis is to analyze the existing legal frameworks, assess their effectiveness, and highlight key challenges and risks. Special attention is also given to identifying potential gaps in legislation and proposing improvements to the legal regulation in this rapidly evolving field. Today’s all-encompassing globalization, like in many other areas, also affects the production and marketing of illegal medicines. Due to a lack of adequate and precise regulations, such medicines are easily accessible in many countries, including in kiosks, drugstores, and especially online, enabling questionable individuals to make a profit. The internet allows them to remain anonymous and produce substandard medicines in unregulated conditions, which may be harmful to health or even deadly. Social and technological development, particularly the immense power of the internet, enables individuals to access unsafe medicines from the comfort of their own homes. The broad availability of such products creates numerous opportunities for the development of criminal activity, which, due to its international nature, is difficult to detect and effectively sanction. Based on a comparative legal analysis, it can be concluded that despite the existence of regulatory mechanisms in all three systems under consideration—within the European Union through a common logo and mandatory registration, in the Republic of Slovenia through alignment with EU legislation and additional requirements imposed by the Agency for Medicinal Products and Medical Devices, and in the United States through the VIPPS system and oversight by the Food and Drug Administration—numerous common challenges remain. The most significant among them include insufficient oversight of cross-border online sales, inadequate sanctions, low consumer awareness, and the fact that regulation often fails to keep pace with the rapid development of digital technology. farmacevtska zakonodaja e-lekarništvo oglaševanje zdravil na spletu dostopnost zdravil preko spleta varstvo potrošnikov. Pharmaceutical legislation E-pharmacy Online advertising of medicines Accessibility of medicines online Consumer protection. true true false N. Levanič Slovenski jezik Angleški jezik Magistrsko delo/naloga 2025-06-04 11:12:33 2025-09-03 15:16:22 2025-09-04 03:32:39 0000-00-00 00:00:00 2025 0 Maribor 0 Maribor 1 spletni vir (1 datoteka PDF (59 str.)) 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 346:61(043.3) 247576067 MAG_Levanic_Nika_2025.pdf MAG_Levanic_Nika_2025.pdf 1 D725FBF9266F5AAEA86045531C8E0A70 52c4b1de5c724c0e9b671bf2a5d7a93617d4c43995632ae3e836c7e22eb9bb26 88db0691-46a6-11f0-b893-00155d000105 https://dk.um.si/Dokument.php?lang=slv&id=192086 Pravna fakulteta 0 0 0