Medicinal products within the meaning of Directive 2001/83/EC Tissue and tissue preparations within the meaning of Directive 2004/23/EC

Draft Act updating the provisions concerning blood and tissue preparations

Adaptation of the provisions concerning advanced therapy medicinal products and tissue preparations in line with current scientific and technical developments and experience of enforcement, in particular the expansion of the documents to be presented in relation to the approval of these medicinal products, the extension of the obligation to disclose as regards amendments, the new authorisation requirement for certain changes, and adaptation of the definition of advanced therapy medicinal products 'prepared on a non-routine basis'.Procedural simplifications for advanced therapy medicinal products which comprise a genetically modified organism or contain such organisms, as well as for irradiated advanced therapy medicinal products and tissue preparations.