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Original scientific paper

Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices

Siniša Tomić ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Anita Filipović Sučić ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Ana Plazonić ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Rajka Truban Žulj ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Viola Macolić Šarinić ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Branka Čudina ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Adrijana Ilić Martinac ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia

Fulltext: english, pdf (302 KB) pages 104-112 downloads: 554* cite
APA 6th Edition
Tomić, S., Filipović Sučić, A., Plazonić, A., Truban Žulj, R., Macolić Šarinić, V., Čudina, B. & Ilić Martinac, A. (2010). Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices. Croatian medical journal, 51 (2), 104-112. Retrieved from https://hrcak.srce.hr/53512
MLA 8th Edition
Tomić, Siniša, et al. "Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices." Croatian medical journal, vol. 51, no. 2, 2010, pp. 104-112. https://hrcak.srce.hr/53512. Accessed 11 Jul. 2020.
Chicago 17th Edition
Tomić, Siniša, Anita Filipović Sučić, Ana Plazonić, Rajka Truban Žulj, Viola Macolić Šarinić, Branka Čudina and Adrijana Ilić Martinac. "Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices." Croatian medical journal 51, no. 2 (2010): 104-112. https://hrcak.srce.hr/53512
Harvard
Tomić, S., et al. (2010). 'Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices', Croatian medical journal, 51(2), pp. 104-112. Available at: https://hrcak.srce.hr/53512 (Accessed 11 July 2020)
Vancouver
Tomić S, Filipović Sučić A, Plazonić A, Truban Žulj R, Macolić Šarinić V, Čudina B, et al. Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices. Croat Med J. [Internet]. 2010 [cited 2020 July 11];51(2):104-112. Available from: https://hrcak.srce.hr/53512
IEEE
S. Tomić, et al., "Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices", Croatian medical journal, vol.51, no. 2, pp. 104-112, 2010. [Online]. Available: https://hrcak.srce.hr/53512. [Accessed: 11 July 2020]

Abstracts
Aim To present the activities of the Agency for Medicinal
Products and Medical Devices in the first 5 years of its existence
and to define its future challenges.
Methods Main activities within the scope of the Agency
as a regulatory authority were retrospectively analyzed for
the period from 2004-2008. Data were collected from the
Agency’s database and analyzed by descriptive statistics.
Results The number of issued medicine authorizations
rose from 240 in 2004 to 580 in 2008. The greatest number
of new chemical and biological entities was approved
in 2005. The greatest number of regular quality controls
(n = 5833) and special quality controls was performed in
2008 (n = 589), while the greatest number of off-shelf quality
controls (n = 132) was performed in 2007. The greatest
number of medicine labeling irregularities was found
in 2007 (n = 19) and of quality irregularities in 2004 (n = 9).
The greatest number of adverse reactions was reported in
2008 (n = 1393). The number of registered medical devices
rose from 213 in 2004 to 565 in 2008.
Conclusion Over its 5 years of existence, the Agency has
successfully coped with the constant increase in workload.
In the future, as Croatia enters the European Union, the
Agency will have to face the challenge of joining the integrated
European regulatory framework.

Keywords
medicinal product; marketing authorization; variations; quality control; quality defect; pharmacovigilance; international co-operation; medical devices

Hrčak ID: 53512

URI
https://hrcak.srce.hr/53512

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