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Commission of the European Communities. COMMISSION DIRECTIVE 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products.

Published by European Commission (EC)

Medicinal ProductsAdvanced Therapy Regulation

This Directive addresses the definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products should be updated

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DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.

Published by European Commission (EC)

GMOGenetically Modified Organisms

This Directive set the regulation of the environment of genetically modified organisms. The protection of human health and the environment  from the deliberate releaset of genetically modified organisms 

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DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

Published by European Commission (EC)

Quality and SafetyDonationProcessingPreservationDistributionHuman Tissues and Cells

This Directive sets the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

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COMMISSION DIRECTIVE 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

Published by European Commission (EC)

Human Tisssue and CellsDonationTechnical RequirementsTesting

This Directive that set the technical requirements for the donation, procurement and testing of human tissues and cells.

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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 (EC)

Human Tissue and CellsTechnical Requirements

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 (EC)

Good PracticeClinical TrialsGMO

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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