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Stručni rad
https://doi.org/10.2478/10004-1254-61-2010-2015

New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

Adrijana Ilić Martinac ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Siniša Tomić ; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Mirna Šimičić ; Jadran Galenski Laboratorij d.d., Rijeka, Croatia

Puni tekst: engleski, pdf (124 KB) str. 311-321 preuzimanja: 586* citiraj
APA 6th Edition
Ilić Martinac, A., Tomić, S. i Šimičić, M. (2010). New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation. Arhiv za higijenu rada i toksikologiju, 61 (3), 311-321. https://doi.org/10.2478/10004-1254-61-2010-2015
MLA 8th Edition
Ilić Martinac, Adrijana, et al. "New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation." Arhiv za higijenu rada i toksikologiju, vol. 61, br. 3, 2010, str. 311-321. https://doi.org/10.2478/10004-1254-61-2010-2015. Citirano 27.11.2021.
Chicago 17th Edition
Ilić Martinac, Adrijana, Siniša Tomić i Mirna Šimičić. "New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation." Arhiv za higijenu rada i toksikologiju 61, br. 3 (2010): 311-321. https://doi.org/10.2478/10004-1254-61-2010-2015
Harvard
Ilić Martinac, A., Tomić, S., i Šimičić, M. (2010). 'New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation', Arhiv za higijenu rada i toksikologiju, 61(3), str. 311-321. https://doi.org/10.2478/10004-1254-61-2010-2015
Vancouver
Ilić Martinac A, Tomić S, Šimičić M. New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation. Arh Hig Rada Toksikol. [Internet]. 2010 [pristupljeno 27.11.2021.];61(3):311-321. https://doi.org/10.2478/10004-1254-61-2010-2015
IEEE
A. Ilić Martinac, S. Tomić i M. Šimičić, "New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation", Arhiv za higijenu rada i toksikologiju, vol.61, br. 3, str. 311-321, 2010. [Online]. https://doi.org/10.2478/10004-1254-61-2010-2015

Sažetak
Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

Ključne riječi
efficacy; Medicinal Products Act; quality; registration documentation; safety

Hrčak ID: 58443

URI
https://hrcak.srce.hr/58443

[hrvatski]

Posjeta: 1.045 *