Medicinska konoplja - regulatorni status i kontrola kakvoće

postgraduate specialist thesis

• Author: Ivana Mihalic
• Mentor: Sanda Vladimir-Knežević (mentor)
• Committee member: Renata Jurišić Grubešić (predsjednik povjerenstva)
• Committee member: Sanda Vladimir-Knežević (član povjerenstva)
• Committee member: Josipa Cvek (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmacognosy); Zagreb
• Defense date and country: 2024-09-27, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja
Cilj ovog specijalističkog rada je dati sveobuhvatan pregled recentnih podataka o regulativi i
metodama ispitivanja kakvoće biljne droge i ljekovitih pripravaka na bazi medicinske konoplje
te tako doprinijeti boljem razumijevanju važećih zakonskih propisa za stavljanje na tržište i
osiguranje njihove kakvoće.
Materijal i metode
Istraživanje u okviru ovog rada je teorijskog karaktera i uključuje pregled dostupne znanstvene
i stručne literature o predloženoj temi te odgovarajući zakonodavni akti i smjernice dostupne
na stranicama nadležnih regulatornih tijela. Dostupni podaci su kritički razmotreni i
sistematično prikazani u obliku preglednog rada.
Rezultati
Intenzivno se razvijaju različite analitičke metode pogodne za analizu sastava različitih
pripravaka na bazi medicinske konoplje. Osnove za ujednačenu kontrolu kakvoće biljnih tvari,
pripravaka i lijekova na bazi medicinske konoplje na razini EU postavljene su u farmakopejskoj
monografiji Cannabis flos u Europskoj Farmakopeji koja je uspostavljena u srpnju 2024.
godine. S regulatornog aspekta, svi lijekovi na bazi medicinske konoplje i kanabinoida moraju
imati dozvolu za primjenu u liječenju, odnosno proći registracijski postupak pri nadležnim
Europskim ili nacionalnim regulatornim tijelima. Svi trenutačno dostupni lijekovi na bazi
kanabinoida u Europi odobreni su putem ocjene cjelovite dokumentacije u standardnom
registracijskom postupku.
Zaključci
Zbog povijesnih okolnosti, dinamika odobravanja medicinske upotrebe konoplje značajno je
različita u pojedinim državama Europe. U Republici Hrvatskoj dozvoljena je medicinska
upotreba i uzgoj medicinske konoplje, uz poštivanje važećeg regulatornog okvira. Uvrštavanje
monografije biljne droge konopljin cvijet (Cannabis flos) u Europsku farmakopeju predstavlja
značajan iskorak u osiguranju kakvoće lijekova i pripravaka od medicinske konoplje.

Abstract (english)

Objectives
The aim of this work was to provide a comprehensive overview of recent data on regulations
and analytical methods for the quality control of herbal drug and medicinal products based
on medical cannabis and to contribute to a better understanding of the current legal
framework for placing them on the market and ensuring their quality.
Material and methods
The research conducted for this work is theoretical in nature and includes a review of the
available scientific and professional literature on the proposed topic, as well as the relevant
legislation and guidance on the websites of the relevant regulatory authorities. The data was
critically reviewed and systematically presented in the form of a review paper.
Results
There has been intensive development of analytical methods specifically designed to analyze
the composition of various medical cannabis-based preparations. The basis for uniform quality
control of plant substances, preparations and medicinal products based on medical cannabis
at EU level was created with the pharmacopoeial monograph Cannabis flos, published in July
2024. From a regulatory perspective, all cannabis-based medicinal products must be approved
by the competent European or national regulatory authorities. All cannabinoid-based
medicinal products currently available in Europe have been authorized through full
documentation under the standard registration procedure.
Conclusion
Due to historical circumstances, the dynamics of authorizing the medicinal use of cannabis
vary widely across different European countries. In the Republic of Croatia, the medicinal use
and cultivation of medical cannabis are permitted in accordance with the applicable
regulatory framework. The inclusion of the monograph Cannabis flos in the European
Pharmacopoeia represents a significant step forward in ensuring the quality of medicinal
products and preparations based on medical cannabis

• Keywords: medicinska konoplja; Europska farmakopeja; legislativa; kontrola kvalitete
• Keywords (english): medical cannabis; European Pharmacopoeia; legislation; quality control
• Language: croatian
• URN:NBN: urn:nbn:hr:163:721393
• Study programme: Title: Phytopharmacy with dietotherapy - specialistic study - university study; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni specijalist fitofarmacije s dijetoterapijom (sveučilišni specijalist fitofarmacije s dijetoterapijom)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2025-02-11 12:38:46