| New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation. | |
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MedLine Citation:
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PMID: 20860972 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Adrijana Ilić Martinac; Sinisa Tomić; Mirna Simicić |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Arhiv za higijenu rada i toksikologiju Volume: 61 ISSN: 0004-1254 ISO Abbreviation: Arh Hig Rada Toksikol Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-09-23 Completed Date: 2011-01-25 Revised Date: 2012-05-03 |
Medline Journal Info:
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Nlm Unique ID: 0373100 Medline TA: Arh Hig Rada Toksikol Country: Croatia |
Other Details:
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Languages: eng Pagination: 311-22 Citation Subset: IM |
Affiliation:
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Agency for Medicinal Products and Medical Devices, Zagreb. adrijana.ilic@halmed.hr |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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European Union* Legislation, Drug* Marketing / legislation & jurisprudence* Pharmaceutical Preparations / standards* Safety |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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