Tissue law

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Basic data
Title: Law on the quality and safety of human tissues and cells
Short title: Tissue law
Abbreviation: FabricG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Administrative law , medical law
Issued on: July 20, 2007 ( BGBl. I p. 1574 )
Entry into force on: August 1, 2007
Last change by: Art. 17 G of 9 August 2019
( Federal Law Gazette I p. 1202, 1218 )
Effective date of the
last change:
August 16, 2019
(Art. 21 G of August 9, 2019)
GESTA : M014
Weblink: Text of the law
Please note the note on the applicable legal version.

The Tissue Act is an amending act that adapts several laws relating to the handling of human tissues and cells, as well as medical preparations made from human tissue.

With the law, Directive 2004/23 / EC is implemented in German law. Among other things, the Medicines Act , the Transplantation Act and the Transfusion Act were changed.

aims

Transplant Act

The aim of the transplantation law was:

  • Extension of the TPG's scope of application to bone marrow and cells as well as embryonic and fetal organs and tissues.
  • Legal priority of organ donation over tissue donation .
  • Restriction of bone marrow collection from those unable to consent.
  • Regulation of the anonymity of tissue donation with the exception of sperm donation and bone marrow donation.
  • Regulations on tissue facilities and the documentation of the transferred tissues as well as the reporting of serious incidents and serious adverse reactions by medical care facilities.

Medicines Act

The aim of the Medicines Act was to:

  • Extension of the scope of application of the AMG to include corneas and tissue that are obtained, processed or used in hospitals under the responsibility of a doctor.
  • Simplified regulation for the authorization of the removal of tissues to be used in humans.
  • Permission to work or process tissues that are not industrially manufactured and whose machining or processing methods are sufficiently known in the European Union (e.g. heart valves , corneas)
  • Simplified approval procedure for the placing on the market of tissues that have been treated or processed using known procedures, also with the result that these tissues are subject to the trade ban under Section 17 (1) of the Transplantation Act.
  • Easier import permit for fabrics that are known and are to be imported into Germany from third countries.
  • Tissue facility reporting requirements for Serious Incidents and Responses.

See also

Web links

Individual evidence

  1. Directive 2004/23 / EC