LEGAL FRAMEWORk GOVERNING THE TYPES AND HANDLING OF MEDICINAL PRODUCTS WITH AN OVERVIEW OF PRINCIPLES OF GOOD PHARMACY IN THE PROVISION OF PHARMACEUTICAL SERVICES IN SERBIA

Jovana Cicmil

doi:10.51738/kpolisa.2026.1r.jc

Autori

Jovana Cicmil Farmaceutski fakultet, Novi Sad https://orcid.org/0000-0003-0254-3685

DOI:

https://doi.org/10.51738/kpolisa.2026.1r.jc

Ključne reči:

lek, medicinsko sredstvo, farmaceutska delatnost, Dobra apotekarska praksa, zdravstvena zaštita

Apstrakt

Zdravstveni sistem predstavlja jedan od najsloženijih sistema u bilo kojoj državi. Članom 65. Zakona o zdravstvenoj zaštiti uređeno je da se u zdravstvenu delatnost na primarnom nivou zdravstvene zaštite ubraja, između ostalog i farmaceutska zdravstvena zaštita. Na nacionalnom nivou svaka država ima uspostavljen pozitivnopravni sistem uređenja oblasti koja se odnosi na vrste i tretman lekova, kao i svih drugih ključnih pitanja, a koji je zasnovan na donošenju odgovarajućih zakona i podzakonskih akata. Smatra se da svaka terapija lekom obavezno imlicira koherentnost u pristupu svih učesnika - i pacijenta, i lekara, i farmaceuta, kao i drugih učesnika u ovom procesu čije su medicinske usluge potrebne. U radu je nakon kraćeg osvrta na pojam i značaj farmaceutske delatnosti, lekova i medicinskih sredstava, analizirana pravna regulativa koja uređuje vrste i tretman lekova, pri čemu su pored analize važećih zakona predstavljeni i relevantni podzakonski akti. Na kraju, učininjen je osvrt na principe Dobre apotekarske prakse u pružanju farmaceutske usluge u Srbiji.

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Reference

Alanazi, A. S., Alfadl, A. A. & Hussain, A.S. (2016). Pharmaceutical care in the community pharmacies of Saudi Arabia: present status and possibilities for improvement, Saudi J Med Med Sci, 4, 9–14. DOI 10.4103/1658-631X.170881.

Alen, L. V., Popovich, N.G. & Ansel, H.C. (2011). Ansel's pharmaceutical dosage forms and drug delivery systems. Baltimore: Lippincott wi liams & wilkins.

Alrasheedy, A. A. (2024). Pharmaceutical Activities, Services, Medicines, and Products at Community Pharmacies in the Qassim Region of Saudi Arabia: Findings and Implications for the Future, Cureus, 16 (8), e67957. DOI 10.7759/cureus.67957.

Bel, J.S., Vaananen, M., Ovaskainen, H., Narhi, U. & Airaksinen, M. S. (2007). Providing patient care in community pharmacies: practice and research in Finland, Ann Pharmacother; 41 (6), 1039–1046. DOI: 10.1345/aph.1H638.

Cucić, V., Simić, S., Bjegović, V., Živković, M., Doknić Stefanović, D. & Vuković, D. (2000). Socijalna medicina [Social medicine]. Beograd: Savremena administracija.

Đekić, Lj., Čalija, B. & Vuleta, G. (2013). Izrada magistralnih i galenskih lekova – propisi i standardi [Production of magisterial and galenic medicines - regulations and standards], Arhiv za farmaciju, 63 (5), 443–469.

Evans, D. B., Tandon, A., Murray, C. J. & Lauer, J. A. (2001). Comparative e ficiency of national health systems: cross national econometric analysis. BMJ, 323 (11), 307–310. DOI: 10.1136/bmj.323.7308.307.

Farmaceutska komora Srbije [Pharmaceutical Chamber of Serbia] (2021). Vodič dobre apotekarske prakse [Guide to good pharmacy practice]. Beograd. https://www.farmkom.rs/pdf/stranice/Vodi%C4%8D%20DAP.pdf

Herborg, H., Sorensen, E. w. & Frokjaer, B. (2007) Pharmaceutical care in community pharmacies: practice and research in Denmark, Ann Pharmacother, 41 (4), 681-689. DOI: 10.1345/aph.1H645.

Janković, D. (2011). Zdravstveno osiguranje kao faktor troškova zdravstvene zaštite [Health insurance as a factor in health care costs], Škola biznisa, 4, 69–82.

Jovanović, S., Milovanović, S., Mandić, J. & Jovović, S. (2015). Sistemi zdravstvene zaštite [Health care systems]. Engrami, 37 (1), 75-82.

Jovanović, Ž. (2016). Upravljanje strateškim promenama u farmaceutskoj industriji (Doktorska disertacija, Fakultet organizacionih nauka, Univerzitet u Beogradu) [Strategic Change Management in Pharmaceutical Industry, Faculty of Organizational Sciences, University of Belgrade]. Beograd. https://nardus.mpn.gov.rs/bitstream/handle/123456789/6876/Disertacija.pdf

Jović, S. & Tasić, Lj. (2009). Dobra apotekarska praksa – značaj i uloga u farmaceutskoj delatnosti Srbije [Good pharmacy practice - importance and role in the pharmaceutical industry of Serbia], Arhiv za farmaciju, 59 (1), 1–12.

Kočović, J., Rakonjac-Antić, T. & Rajić, V. (2013). Dobrovoljno zdravstveno osiguranje kao dopuna obaveznom zdravstvenom osiguranju u Srbiji [Voluntary health insurance as a supplement to mandatory health insurance in Serbia]. Ekonomske teme, 51 (3), 541–560.

Kosanović, R. (2011). Socijalno pravo [Social law]. Beograd: Friedrich Ebert Stiftung.

Kosanović, R. & Anđelski, H. (2015). Osnovni pravci razvoja zdravstvenog osiguranja u Republici Srbiji (1922−2014) [Basic trends in the development of health insurance in the Republic of Serbia (1922−2014)]. Zdravstvena zaštita, 44 (3), 48–70.

Ministarstvo zdravlja [Ministry of Health] (2011). Pravilnik o načinu kontrole kvaliteta lekova i medicinskih sredstava [Rulebook on the method of quality control of medicines and medical devices], Službeni glasnik RS, br. 64/2011, 63/2013, 99/2018 - dr. pravilnik, 93/2022, 102/2022, 87/2023 i 63/2024. https://www.paragraf.rs/propisi/pravilnik-o-nacinu-kontrole-kvaliteta-i-lekova-i-medicinskihsredstava.html

Ministarstvo zdravlja [Ministry of Health] (2022). Pravilnik o kliničkom ispitivanju lekova u humanoj medicine [Rulebook on clinical testing of drugs in human medicine], Službeni glasnik RS, br. 51/2022, 65/2023, 86/2023 i 97/2024. https://pravno-informacioni-sistem.rs/eli/rep/sgrs/ministarstva/pravilnik/2024/97/5

Ministarstvo zdravlja [Ministry of Health] (2025). Smernice dobre kliničke prakse [Good clinical practice guidelines], Službeni glasnik RS, br. 65/2025. https://pravno-informacioni- sistem.rs/eli/rep/sgrs/ministarstva/drugiakt/2025/65/1/reg

Ministarstvo zdravlja [Ministry of Health] (2011). Pravilnik o načinu prijavljivanja, prikupljanja i praćenja neželjenih reakcija na lekove [Rulebook on how to report, co lect and monitor adverse drug reactions], Službeni glasnik RS, br. 64/2011, 75/2017, 82/2017 – ispr. i 107/2023. https://www.paragraf.rs/propisi/pravilnik-o-nacinu-prijavljivanja-prikupljanja-i-pracenja-nezeljenihreakcija-na-lekove.html

Ministarstvo zdravlja [Ministry of Health] (2018). Pravilnik o obrascu i sadržini lekarskog recepta, načinu izdavanja i propisivanja lekova [Rulebook on the form and content of a doctor's prescription, the method of issuing and prescribing medicines], Službeni glasnik RS, br. 74/2018, 87/2018, 47/2019, 90/2019, 150/2020, 127/2021, 134/2022, 143/2022, 2/2023, 115/2023, 24/2024, 55/2024, 101/2024 i 105/2025. https://pravno-informacioni-sistem.rs/eli/rep/sgrs/ministarstva/pravilnik/2018/74/2/reg

Ministarstvo zdravlja [Ministry of Health] (2010). Pravilnik o načinu oglašavanja leka, odnosno medicinskog sredstva [Rulebook on the method of advertising a medicine, that is, a medical device], Službeni glasnik RS, br. 79/2010 i 102/2018 – dr. pravilnik. https://www.paragraf.rs/propisi/pravilnik_o_nacinu_oglasavanja_leka_odnosno_medicinskog_sredstva.html

Mitrović, M. & Gavrilović, A. (2013). Organizacija i menadžment u zdravstvenom sistemu Srbije [Organization and management in the healthcare system of Serbia]. FBIM Transactions, 1 (2), 145–158.

Mohammed, E., Khanal, S., Jalal, Z., Cheema, E., Abutaleb, M. H. &, Paudyal, V. (2021). Perceived barriers and facilitators to uptake of non-traditional roles by pharmacists in Saudi Arabia and implications for COVID-19 pandemic and beyond: a qualitative study using Theoretical Domain Framework, J Pharm Policy Pract, 14 (1), 25. DOI: 10.1186/s40545-021-00307-w.

Mujović Zornić, H. (2008). Farmaceutsko pravo [Pharmaceutical law], Beograd: Nomos.

Narodna skupština Republike Srbije [National Assembly of the Republic of Serbia] (2010). Zakon o lekovima i medicinskim sredstvima [Law on Medicines and Medical Devices], Službeni glasnik RS, br. 30/2010, 107/2012, 113/2017 – dr. zakon i 105/2017 – dr. zakon. https://www.paragraf.rs/propisi/zakon_o_lekovima_i_medicinskim_sredstvima.html

Narodna skupština Republike Srbije [National Assembly of the Republic of Serbia] (2017). Zakon o medicinskim sredstvima [Law on medical devices], Službeni glasnik RS, br. 1052017. https://www.paragraf.rs/propisi/zakon-o-medicinskim-sredstvima.html

Narodna skupština Republike Srbije [National Assembly of the Republic of Serbia] (2006). Ustav Republike Srbije [Constitution of the Republic of Serbia], Službeni glasnik RS, br. 98/2006 i 115/2021. https://www.paragraf.rs/propisi/ustav_republike_srbije.html

Narodna skupština Republike Srbije [National Assembly of the Republic of Serbia] (2019). Zakon o zdravstvenoj zaštiti [Health Care Law]. Službeni glasnik RS, br. 25/2019, 92/2023 – autentično tumačenje i 29/2025 – odluka US. https://www.paragraf.rs/propisi/zakon_o_zdravstvenoj_zastiti.html

Narodna skupština Republike Srbije [National Assembly of the Republic of Serbia] (2019). Zakon o zdravstvenom osiguranju [Law on Health Insurance]. Službeni glasnik RS, br. 25/2019, 92/2023 i 109/2025 – dr. zakon. https://www.paragraf.rs/propisi/zakon_o_zdravstvenom_osiguranju.html

Noyce, P. R. (2007). Providing patient care through community pharmacies in the UK: policy, practice, and research. Ann Pharmacother. 41 (5), 861-868. DOI: 10.1345/aph.1K015.

Radivojević, V. & Vesić, S. (2020). Neki aspekti razvoja zdravstvenog sistema Srbije i Japana [Some aspects of the development of the healthcare system in Serbia and Japan]. Naučne publikacije Državnog univerziteta u Novom Pazaru – Serija B: Društvene & humanističke nauke, 3 (2), 152–165.

Remington, J. P. (2012). The Science and Practice of Pharmacy, London: Pharmaceutical Press.

Republički fond za zdravstveno osiguranje [Republic Fund for Health Insurance] (2025). Pravilnik o listi lekova koji se propisuju i izdaju na teret sredstava obaveznog zdravstvenog osiguranja [Rulebook on the list of medicines that are prescribed and issued at the expense of compulsory health insurance funds], Službeni glasnik RS, br. 50/2025, 91/2025 i 13/2026. https://www.paragraf.rs/propisi/pravilnik_o_listi_lekova_koji_se_propisuju_i_izdaju_na_teret_sredstava_obaveznog_zdravstvenog_osiguranja.html

Rossing, C., Hansen, E. H., Traulsen, J. M. & Krass, I. (2005). Actual and perceived provision of pharmaceutical care in Danish community pharmacies: the pharmacists' opinions, Pharm World Sci, 27 (3), 175-181. DOI: 10.1007/s11096-004-1732-3.

Simic, S. (2012). Zdravstveni sistemi [Health systems]. Beograd: Medicinski fakultet, Centar – Škola javnog zdravlja.

Tasić, Lj., Hadži-Arsić Novaković, S. (2005). Znanjem do kvaliteta u farmaceutskom poslovanju [From knowledge to quality in pharmaceutical business], Total quality management & exce lence, 33 (12), 225-227.

Vrcelj Jovanović, S., Vukajlović, I. & Stajković, Z. (2022). Nacionalni registar lekova [National Medicines Registry]. Beograd: Agencija za lekove i medicinska sredstva Srbije.

Westerlund, L.T. & Bjork, H.T. (2006). Pharmaceutical care in community pharmacies: practice and research in Sweden, Ann Pharmacother, 40 (6), 1162-1169. DOI: 10.1345/aph.1G680.