Information for all Designated Individuals and named contacts
The HTA ’s powers come from three pieces of legislation:
- The Human Tissue Act 2004 (HT Act)
- The Human Tissue (Quality and Safety for Human Application) Regulations 2007
- The Quality and Safety of Organs Intended for Transplantation Regulations 2012
These set out the consent and licensing requirements for different sectors, as well as the responsibilities of Designated Individuals.
The HTA licenses and inspects organisations across the six different sectors:
- Public Display
- Human Application
- Organ Donation and Transplantation
The information below lists the HTA’s governing legislation along with the types of licences created by each.
The Human Tissue Act 2004 and associated Regulations:
The Human Tissue (Quality and Safety for Human Application) Regulations 2007:
The Quality and Safety of Organs Intended for Transplantation Regulations 2012:
If you are a DI or a named contact, you will need access to the HTA Portal. You will use the HTA portal to securely send data and reports to the HTA.
- submitting compliance updates
- submitting annual activity data
- reporting Serious Adverse Events or Reactions
- reporting post mortem HTA Reportable Incidents
We recommend that you make sure your PDs also have access to the Portal.
Licences are granted for particular activities, for example the removal of tissue from the body of a deceased person, or storage of human tissue, for a particular purpose, to take place on specified premises. These activities are stated on your licence certificate as well as on the licensed establishment page on our website.
If you are licensed in any of the following sectors:
- Human Application;
- Post Mortem;
- Public Display; or
your licence will specify the premises where the licensed activities are authorised to take place.
For the Organ Donation and Transplantation sector, a licence will authorise corporate bodies or individuals to carry out licensed activities.
You can vary your licence at any time. To do this, you will need to apply for a licence variation. Your application needs to be approved before you implement any changes.
To change any details about your licence, please refer to guidance on licence variations.
Any changes to your licence(s) may affect your licensing fees.
Please contact our licensing team for further information: firstname.lastname@example.org.
You can apply for other premises to be licensed as part of your licensing arrangements with the HTA. A satellite site is a separate location where licensed activities can be carried out, provided they are subject to the same governance arrangements as the main (hub) site with oversight by the same DI.
DIs have a legal duty to ensure that statutory and regulatory requirements are met. They are responsible for supervising licensed activities and ensuring suitable practices are taking place. An establishment licensed under the HT Act or Q&S Regulations must have a DI.
For licences under The Quality and Safety of Organs Intended for Transplantation Regulations 2012, there must be a Named Contact for each clinical area of specialty.
PDs assist DIs in ensuring compliance with HTA standards. PDs can assist with developing procedures, as well as reporting incidents. If you have satellite sites, there should be at least one PD for each site.
A licence holder can be an individual or a corporate body. We recommend that a licence holder is a senior manager from a corporate body, acting as the representative on its behalf.
We carry out inspections of premises licensed in the Anatomy, Human Application, Post mortem, Public Display and Research sectors.
Information about the standards you will be inspected against is contained in the sector-specific pages of this section.
You can also read our general guidance on HTA inspections.
When you have a planned inspection coming up, we will send you a draft timetable for the day. We will usually also send you a document review checklist, relevant to your sector:
- Human Application
- Post mortem
- Public Display
In most cases, you will be notified in advance of your inspection. However, we may also carry out an unannounced inspection if we think it is necessary.
We carry out audits of establishments licensed in the organ donation and transplantation sector.
We audit establishments against specific assessment criteria and gather evidence through a combination of an audit of the premises, review, and interviews with staff involved in each aspect of the ‘organ pathway’.
In most cases, you will be notified in advance of your audit. However, we may also carry out an unannounced audit if we think it is necessary.
We collect compliance information every two years from establishments licensed in the Anatomy, Organ Donation and Transplantation, Post mortem, Public Display and Research sectors.
We will contact DIs and named contacts directly to notify you when you need to submit compliance information.