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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...
There are licensing exemptions in the HT Act 2004 and further specific exemptions in the HT Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006. These regulations came into force on 1 September 2006.
The removal licence is one of the HTA's lesser used licence type, principally because the activity of removal is covered by many of our other licences. A removal licence can be applied for if you wish to only remove relevent material, rather than storing or processing it as well.
Designated Individuals have a key role to play in implementing the requirements of the Human Tissue Act. They are the person under whose supervision the licensed activity is authorised to be carried out. They have the primary (legal) responsibility under Section 18 of...
DIs and LHs both play key roles in the licensing arrangements under the Human Tissue Act (2004) and the Q&S Regulations. This section explains the roles and responsibilities of these individuals under the Q&S Regulations. Separate guidance is available on the role of Designated...
Procurement is defined as the processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation.
The Regulations (PDF) were implemented on 5 July 2007 bringing the into UK law. The directive and it's subsequent updates are as follows: