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Tissues, Cells and Organs

Quality and Safety of Human Tissues and Cell
The increasing use of human tissues and cells for therapeutic purposes has focused attention on the need to ensure their quality and safety. This demands the setting of standards and binding requirements to ensure quality and safety of human tissues and cells throughout the whole transplantation process from donor to patient. Risks must be controlled by the application of stringent donor selection criteria and comprehensive quality systems. The Health Care Services Standards Directorate has prime role to play in the regulatory framework that puts in place such quality and safety standards.

The Legal Background
Standards for the quality and safety of blood, tissues and cells are set in Maltese legislation through the Blood and Transplants Act (Chapter 483) and its subsidiary legislation. This legislation transposes a number of EU directives dealing with substances of human origin.

Maltese Legislation
Tissues and Cells

Organs

EU Directives
Tissues and Cells
  1. Directive 2004/23/EC setting the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells
  2. Directive 2006/17/EC implementing Directive 2004/23 EC as regards certain technical requirements for the donation, procurement and testing of human tissue and cells, as amended by Directive 2012/39
  3. Directive 2006/86/EC implementing Directive 2004/23/EC 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 cells
  4. Directive 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
  5. Directive 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells​

Organs

Report Forms

Application Forms