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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

Organs

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)

Template for the Annual Activity Report on Tissue and Cell Establisments
Notification of Import of Tissues and Cells from EEA area
Notification of Import of Tissues and Cells from outside EEA area