| Granting marketing authorisation for medicines in South East European countries: the point of view of the authority. | |
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MedLine Citation:
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PMID: 20385190 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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European legislation for medicines places the emphasis on an assessment of quality, safety and efficacy during the procedure for the granting of marketing authorisations for medicines, in order to protect patient health. The integrated European regulatory system involves the participation of a network of experts from the agencies of the member states that takes part in the European procedures for the authorisation of medicines. On the way to full membership in the EU, candidate countries and potential candidates have to transpose and implement the European directives for medicinal products; they must also strengthen their scientific and administrative capacities. Croatia acquired good experience in implementing the simplified marketing authorisation procedure for medicines authorised in the EU pursuant to the New Collaboration Agreement between Drug Regulatory Authorities in Central and East European Countries (nCADREAC), which helps it to exchange information and prepare for the implementation of European procedures. However, there are still some provisions to transpose before actual full membership, and also dossier upgrading, in which the marketing authorisation holder has to harmonise its documentation about a medicinal product with the requirements of the directives, if a product already on the market was not previously approved in line with current European legislation. Collaboration with the European Medicines Agency (EMA) through an Instrument for Pre-Accession (IPA) provides candidate countries and potential candidates the opportunity for education and training in some regulatory activities as well as the participation of their representatives as observers in some EMA committees and working groups. Some characteristics of the national regulatory frameworks of the countries of South East Europe in their efforts to achieve harmonisation with EU legislation are presented in this paper. |
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Authors:
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Sinisa Tomić; Anita Filipović Sucić; Adrijana Ilić Martinac |
Publication Detail:
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Type: Journal Article Date: 2010-04-10 |
Journal Detail:
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Title: Regulatory toxicology and pharmacology : RTP Volume: 57 ISSN: 1096-0295 ISO Abbreviation: Regul. Toxicol. Pharmacol. Publication Date: 2010 Jul-Aug |
Date Detail:
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Created Date: 2010-06-02 Completed Date: 2010-09-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8214983 Medline TA: Regul Toxicol Pharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 325-32 Citation Subset: IM |
Copyright Information:
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Copyright 2010 Elsevier Inc. All rights reserved. |
Affiliation:
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Agency for Medicinal Products and Medical Devices, 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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Consumer Product Safety Drug Approval / legislation & jurisprudence*, organization & administration Europe, Eastern European Union Government Regulation Interinstitutional Relations Legislation, Drug* Marketing / legislation & jurisprudence* Pharmaceutical Preparations / adverse effects*, standards |
| 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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