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: Journal Article
Uncontrolled Keywords: advanced medicinal products, gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products, Committee for Advanced Therapies
Depositing User: Ana Vukićević
Date Deposited: 17 Apr 2019 10:34
Last Modified: 24 Mar 2023 09:49
URI: http://repozitorijum.diplomacy.bg.ac.rs/id/eprint/163

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