Title Reguliranje proizvoda medicinske konoplje
Title (english) Regulation of medicinal cannabis products
Author Lara Ramić
Mentor Siniša Tomić (mentor)
Committee member Ana Šešelja Perišin (predsjednik povjerenstva)
Committee member Joško Božić (član povjerenstva)
Committee member Siniša Tomić (član povjerenstva)
Granter University of Split School of Medicine (Pharmacy) Split
Defense date and country 2021-10-15, Croatia
Scientific / art field, discipline and subdiscipline BIOMEDICINE AND HEALTHCARE Pharmacy Pharmacy
Abstract Cilj: Cilj ovog istraživanja je istražiti regulatorni okvir medicinske konoplje na globalnoj razini.
Materijal i metode: Napravljen je pregled postojeće regulacije proizvoda medicinske konoplje u EU, SAD-u, Kanadi, Japanu, Australiji i Novom Zelandu. Analizirani su pravni propisi i zakonski tekstovi koji definiraju status medicinske konoplje u pojedinoj državi. Fokus pretraživanja regulative medicinskog kanabisa bio je na lijekovima s odobrenjem za stavljanje u promet, načinu dobivanja odobrenja za uporabu medicinskog kanabisa, odobrenim indikacijama, načinu propisivanja te pojedinostima karakterističnim za pojedinu državu.
Rezultati: Medicinski kanabis predmet je rasprava i istraživanja na globalnoj razini. Primijećena je dioba proizvoda na bazi kanabisa na one s odobrenjem za stavljanje lijeka u promet i na one bez navedenog odobrenja. Lijek s odobrenjem osigurava pacijentu proizvod s visokim stupnjem kontrole i sigurnosti ustanovljenom kliničkim i ne kliničkim ispitivanjima. Regulatorne agencije u EU, Kanadi, SAD-u, Australiji i Novom Zelandu odobrile su nekoliko lijekova na bazi medicinskog kanabisa za određene indikacije. U Japanu je još uvijek na snazi strogi zakon koji brani ikakvu uporabu kanabisa u medicinske i ne medicinske svrhe. U većini zemalja uspostavljen je regulatorni okvir za uzgajanje medicinskog i ne medicinskog kanabisa te je je definiran postotak THC-a koji dijeli te kategorije. Zajedničko svim obrađenim državama, izuzev Japana, koji tek razmatra uvođenje medicinskog kanabisa, je trend liberalizacije i sve veća zasićenost tržišta svim proizvoda na bazi kanabisa- od prehrambenih proizvoda bez THC-a do odobrenih lijekova za točno definirane indikacije.
Zaključak: Zakoni o regulaciji medicinskog kanabisa variraju ovisno o kontinentu, državi te čak i pokrajini unutar države. Potrebno je ispitati različite modele kontrole te donijeti jedinstveni zaključak o budućnosti medicinskog kanabisa. Dodatna istraživanja o samoj farmakodinamici i farmakokinetici kanabinoida zasigurno će doprinijeti sigurnijem regulatornom okviru koji štiti pacijenta, ali i samog propisivača medicinskog kanabisa.
Abstract (english) Objectives: The aim of this study was to review the regulatory framework medicinal cannabis at a global level.
Material and methods: An overview of existing regulations for medical cannabis products in the EU, USA, Canada, Japan, Australia and New Zealand was made. Legal regulations and legal texts that define the status of medical cannabis in a particular country are analyzed. The focus of the search for medical cannabis regulations was on medicinal products with a marketing authorization, the method of obtaining an authorization for the use of medical cannabis, approved indications, the method of prescribing certain country-specific characteristics.
Results: Medical cannabis is the subject of discussion and research all over the world. A division of cannabis-based products into those with a marketing authorization and those without authorization was observed. The approved medicinal product means the patient wil get a product with a high degree of control and safety established by clinical and non-clinical trials. Regulatory agencies in the EU, Canada, the US, Australia and New Zealand have approved several medical cannabis-based drugs for specific indications. In Japan, a strict law is still in place that prohibits any use of cannabis for medical and non-medical purposes. In most countries, a regulatory framework has been established for the cultivation of medical and non-medical cannabis, and a percentage of THC that divides these categories has been defined. Common to all processed countries, except Japan, which is still considering the introduction of medical cannabis, is the trend of liberalization and increasing market saturation of all cannabis-based products - from food products without THC to approved drugs for well-defined indications.
Conclusion: Laws regulating medical cannabis vary depending on the continent, the state, and even the province within the state. Different control models need to be examined and a unique conclusion drawn about the future of medical cannabis. Additional research on the pharmacodynamics and pharmacokinetics of cannabinoids itself will certainly contribute to a safer regulatory framework that protects the patient, but also the prescriber of medical cannabis.
Keywords
Medicinska marihuana
Farmaceutsko zakonodavstvo
Keywords (english)
Medical Marijuana
Legislation Pharmacy
Language croatian
URN:NBN urn:nbn:hr:171:694699
Study programme Title: Pharmacy Study programme type: university Study level: integrated undergraduate and graduate Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
Type of resource Text
File origin Born digital
Access conditions Open access
Terms of use
Created on 2021-11-08 10:59:02