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Human Tissue Regulations

The Human Tissue (Quality and Safety for Human Application) Regulations 2007, which transpose the EU Tissue and Cells Directive into UK law, came into force on 5th July 2007.

Please notice that the HTA  released Directions 004/2007, which are made under section 23 (1) of the Human Tissue Act 2004 in order to comply with Regulation 15 (1) of the Regulations. These Directions came into force on 7th October 2007 and apply only to import of tissue from non European Economic Area (EEA) states. Member states of the EEA comprise the member states of the EU and Iceland, Liechtenstein and Norway.

Directions 003/2010

The Directions consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007.

These Directions revoke Directions 001/2006, 002/2007 and 004/2007

Covering letter

Directions 003/2010

Guide to quality and safety assurance of human tissues and cells for patient treatments

It is very important that all UK ophthalmologists be familiar with these new Directions prior to any import of ocular tissue from a non EEA state.

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