| Good manufacturing practice: the role of local manufacturers and competent authorities. | |
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MedLine Citation:
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PMID: 21183434 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insufficient resources may have a direct bearing on patients by limiting their access to affordable treatment. |
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Authors:
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Siniša Tomić; Anita Filipović Sučić; Adrijana Ilić Martinac |
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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 Dec |
Date Detail:
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Created Date: 2010-12-24 Completed Date: 2011-04-28 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: 425-36 Citation Subset: IM |
Affiliation:
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Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia. sinisa.tomic@almp.hr |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Croatia Drug Industry / standards* Equipment and Supplies / standards* Europe Humans International Cooperation Legislation, Drug* Licensure Quality Control* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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