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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Concept Paper for the revision of Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products |
| Internet: | http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500059112.pdf |
| Origin/Publisher: | European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/ |
| Content: | The revision of the Note for Guidance, Guideline according to the new terminology, will address the issues identified from clinical experience and provision of Scientific Advice on gene
therapy medicinal products and will lay down detailed and updated requirements for the quality, nonclinical
and clinical aspects of gene therapy medicinal products. |
| Document Type: | Concept Paper |
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