Regulation 23

the biological and functional properties of the human tissue are preserved; and

the risk of contamination of the human tissue is minimised.

ensure that the human tissue is packaged and transported in a validated container;

distribute the human tissue in the appropriate environmental conditions;

take appropriate measures to ensure the human tissue is distributed to the intended recipient;

establish and implement written policies and procedures for —

the recall of the human tissue; and

the notification of any person who receives or has received the human tissue,where the suitability of any human tissue for its intended use is or is believed to have been adversely affected for any reason; and

ensure that an instruction sheet which includes all of the following information accompanies each human tissue distributed by the licensee:

the specific storage conditions for the human tissue prior to its transplant or other clinical use;

any special requirement or measure that the medical practitioner using the human tissue must take to ensure the safe and effective use of the human tissue;

the measures that must be taken if there is any evidence of damage to or mislabelling of the human tissue or its packaging.