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All establishments licensed under the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 must review their licensing records and complete a compliance update.
The information collected will be used to:
If the UK leaves the EU without a deal, it will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directives.
Today the Human Tissue Authority (HTA) has published licence fee levels for the 2019/20 business year.
The new licence fees come into effect from April 2019, with an increase of 2.7% (the CPI rate in August 2018) to the previous year’s fees across all sectors.
The Human Tissue Authority (HTA) had announced licence fee levels for the 2018/19 business year. These licence fees came into effect from April 2018 and was calculated on the same basis as 2017/18.
You can read the full sector breakdowns here.
All establishments licensed under the Human Tissue Act 2004 and the Quality and Safety of Organs for Transplantation Regulations 2012 must complete and submit the compliance update questionnaire on the HTA portal.
In certain circumstances, the Human Tissue Act 2004 makes provision for a Licence Holder or Designated Individual or Licence Applicant to make Representations against a proposed licensing decision and / or make an Appeal to the HTA about a licensing decision.
Do I need a licence under the Human Tissue (Quality and Safety for Human Application) Regulations 2007?
The HTA licenses a number of activities relating to human tissue. We are also responsible for carrying out inspections to ensure licence conditions are being met. These activities are laid out in the Human Tissue Act and associated Regulations.
The activities licensed by the HTA are:
The Human Tissue Act covers primarily England, Wales and Northern Ireland; only section 45 and schedule 4 of the Human Tissue Act include Scotland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA performs certain tasks on behalf of the Scottish...