Regulatorni aspekti pripravaka s vitaminom D

postgraduate specialist thesis

• Author: Vladimir Mihalic
• Mentor: Ivan Pepić (mentor)
• Committee member: Dubravka Vitali Čepo (predsjednik povjerenstva)
• Committee member: Ivan Pepić (član povjerenstva)
• Committee member: Maja Lusina Kregar (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical technology); Zagreb
• Defense date and country: 2024-09-26, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja
Cilj ovog specijalističkog rada je dati sveobuhvatan pregled regulatornih aspekata pripravaka s
vitaminom D s naglaskom na regulatorne specifičnosti pojedine skupine proizvoda (dodaci prehrani i
lijekovi), njihove sličnosti i razlike koje pridonose kakvoći i sigurnosti primjene pripravaka s vitaminom
D.
Materijal i metode
Istraživanje u okviru ovog rada je teorijskog karaktera i uključuje pregled dostupne znanstvene i stručne
literature o predloženoj temi te odgovarajućih zakonodavnih akata i smjernica dostupnih na stranicama
nadležnih regulatornih tijela. Dostupni podaci su kritički razmotreni i sistematično prikazani u obliku
preglednog rada.
Rezultati
Prema podacima iz registra dodatka prehrani i baze lijekova, u Republici Hrvatskoj na tržištu se nalazi
više od 300 pripravaka s vitaminom D, pretežito u kategoriji dodataka prehrani. Osnovne karakteristike
pripravaka s vitaminom D poput količine vitamina D po doznoj jedinici, farmaceutski oblici i namjena
čine dodatke prehrani i lijekove s vitaminom D međusobno usporedivim proizvodima. Dodaci prehrani
s vitaminom D i lijekovi s vitaminom D prolaze različite regulatorne procedure za stavljanje na tržište
te moraju zadovoljiti različite regulatorne zahtjeve kako bi se osigurala kakvoća i sigurnost primjene.
Oba regulatorna okvira imaju međusobne sličnosti s obzirom na svoj osnovni cilj da se na tržištu nalaze
djelotvorni, kvalitetni i sigurni proizvodi, međutim uočene su i prikazane brojne specifične razlike.
Zaključci
Regulatorni zahtjevi iz aspekata kakvoće i sigurnosti primjene koje je potrebno ispuniti da bi dodatak
prehrani s vitaminom D stigao na tržište nisu tako sveobuhvatni kao što je to slučaj za lijekove s
vitaminom D. Krajnja odgovornost za osiguranje kakvoće i zdravstvene ispravnosti dodataka prehrani s
vitaminom D na tržištu Republike Hrvatske, a time i odgovornost za sigurnost potrošača, leži na
poslovnom subjektu koji predmetni dodatak prehrani stavlja na tržište. S druge strane, sustav
regulacije lijekova u Europskoj uniji i Republici Hrvatskoj osigurava visoke standarde sigurnosti,
kvalitete i djelotvornosti lijekova s vitaminom D dostupnih na tržištu Republike Hrvatske.

Abstract (english)

Objectives
The aim of this work is to provide a comprehensive overview of the regulatory aspects of vitamin D
preparations, with an emphasis on the regulatory specificities of each group of products (food
supplements and medicines), their similarities and differences that contribute to the quality and safe
use of vitamin D preparations.
Material and methods
The research within this work is of a theorethical nature and includes a review of the avaliable scientific
and professional literature on the proposed topic and corresponding legal acts and the guidelines
avaliable on the websites of the competent regulatory authorities. The avaliable data were critically
reviewed and systematically presented in the form of an overview paper.
Results
According to data from the register of food supplements and medicinal products database, there are
more than 300 preparations with vitamin D on the market in the Republic of Croatia, predominantly
in the category of food supplements. The basic characteristics of preparations, such as the amount of
vitamin D per dosage unit, pharmaceutical forms and usage, make food supplements and medicines
with vitamin D mutually comparable products. Vitamin D food supplements and vitamin D medicines
are subject to different regulatory procedures before being placed on the market and must comply
with different regulatory requirements to ensure quality and safety. Both regulatory frameworks have
similarities concerning their basic goal of ensuring effective, quality and safe products on the market,
however, numerous specific differences have been observed and presented.
Conclusions
The regulatory requirements in terms of quality and safety that a product must meet to reach the
market are not so comprehensive for a vitamin D food supplement as they are for vitamin D medicines.
The ultimate responsibility for ensuring the quality and health suitability of food supplements with
vitamin D on the market of the Republic of Croatia, and thus the responsibility for consumer safety,
lies with the business operator that places particular food supplement on the market. On the other
hand, the regulatory system for medicines in the European Union and the Republic of Croatia ensures
high standards of safety, quality and effectiveness of vitamin D medicines available on the market of
the Republic of Croatia.

• Keywords: vitamin D; pripravci s vitaminom D; regulativa lijekova
• Keywords (english): vitamin D; vitamin D preparations; drug regulation
• Language: croatian
• URN:NBN: urn:nbn:hr:163:484282
• Study programme: Title: Clinical pharmacy - specialistic study - university study; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni specijalist kliničke farmacije (sveučilišni specijalist kliničke farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2025-03-26 10:57:53