Uredba (EZ) broj 1394/2007 Evropskog parlamenta i Saveta o lekovima za naprednu terapiju

Stojanović, Anđela (2011) Uredba (EZ) broj 1394/2007 Evropskog parlamenta i Saveta o lekovima za naprednu terapiju. Evropsko zakonodavstvo, X (35-36). pp. 241-247. ISSN 1451-3188

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Abstract

Regulation (EC) No 1394/2007 on advanced therapy medicinal products supplements the general provisions of EU law governing medicinal products for human use and Community procedures for the authorisation and supervision of medicinal products for human and veterinary use. The Regulation specifically governs gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products. The Regulation introduces new specific rules for tissue engineered products. Also, it sets up a Committee for Advanced Therapies within the European Medicines Agency.

Item Type: Article
Uncontrolled Keywords: advanced medicinal products, gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products, Committee for Advanced Therapies
Subjects: H Social Sciences > H Social Sciences (General)
Depositing User: iksi iksi
Date Deposited: 13 May 2022 12:08
Last Modified: 08 Dec 2023 12:10
URI: http://institutecsr.iksi.ac.rs/id/eprint/502

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