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Tissues, Cells and Organs

Quality and Safety of Human Tissues and Cells

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 tissues and cells are set in Maltese legislation through the Blood and Transplants Act (Act IV of 2006) and through the Tissues and Cells (Quality and Safety) Regulations, 2006 (L.N. 271 of 2006) and the Human Tissues and Cells (Coding, Processing, Preservation, Storage and Distribution) Regulations, 2007, (L.N. 337 of 2007). These legislations transpose a total of 3 Directives dealing with human tissues and cells that have been adopted by the Commission of the European Communities (Directive 2004/23/EC, Directive 2006/17/EC and Directive 2006/86/EC. The Tissues and Cells (Quality and Safety) Regulations, 2006 L.N. 271 of 2006 transpose Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, and Directive 2006/17/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. The Human Tissues and Cells (Coding, Processing, Preservation, Storage and Distribution) Regulations, 2007, (L.N. 337 of 2007) transpose Commission Directive 2006/86/EC which implements 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 cells.


Maltese Legislation



EU Directives


DOWNLOADS

Report Forms

Serious Adverse Reaction Report Form for Human Tissues and Cells
       Serious Adverse Reaction Report Form for Human Tissues and Cells (WORD)

Serious Adverse Reaction Investigation Report Form For Human Tissues and Cells
       Serious Adverse Reaction Investigation Report Form for Human Tissues and Cells (WORD)

Serious Adverse Events Report Form for Human Tissues and Cells
       Serious Adverse Events Report Form for Human Tissues and Cells (WORD)

Serious Adverse Events Investigation Report Form For Human Tissues and Cells​
       Serious Adverse Events Investigation Report Form For Human Tissues and Cells (WORD)

 
Organ Transplants
Legislation
L.N. 345 of 2012- Organ Transplants (Quality and Safety) Regulations, 2012
Downloads