COMMISSION DIRECTIVE 2006/86/EC of 24 October 2006 Implementing Directive 2004/23/EC of the European Parliament and of the Council as Regards Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements for the Coding, Processing, Preservation, Storage and Distribution of Human tissues and CellsT

Published by European Commission

Technical RequirementsHuman Tissue and Cells

This Comission Directive sets up measures concerning traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

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 European Commission. Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified. Version 5. November 2021

Published by European Commission

GMOGood PracticeClinical Trials

Guideline on Clinical trials with medicinal products that contain or consist of GMOs must also comply with applicable requirements under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms

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European Medicines Agency. Committee for Advanced Therapies (CAT). Procedural Advice on the Provision of Scientific Recommendation on Classification of Advanced Therapy Medicinal Products in Accordance with Article 17 of Regulation (EC) No 1394/2007. EMA/CAT/99623/2009 Rev.2. 5 November 2021

Published by EMA

Comittee for Advanced TherapiesScientific Recommendation

The purpose of this procedure is to allow applicants to clarify whether a given product based on genes, cells or tissues meets the scientific criteria which define ATMPs, in order to address questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops.

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F74European Parliament and Council of the European Union. REGULATION (EC)No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

Published by European Commission

Medicinal ProductsAdvanced Therapy Regulation

This regulation addresses issues related to the definition and  the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering

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