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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:
We inspect establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 at least every two years.
The HTA’s HA licensing standard, GQ2c, requires an audit to be conducted in an independent manner at least every two years. We do this to verify compliance with protocols and HTA standards and that any findings and corrective actions are documented.
You should read the relevant guidance document before you start to fill in the application form.
The guidance documents will tell you:
We have taken a decision to temporarily suspend all scheduled site visit inspections due to the continued increase in COVID-19 cases across the UK.
Establishments still have a duty to uphold our licensing standards and in order to maintain our regulatory oversight, the HTA will be...
In the current circumstances, accessing facilities to undertake routine tasks may be difficult. However, HTA-licensed establishments must make sure that they have arrangements in place to maintain the dignity of the deceased.
We understand that the COVID-19 pandemic is presenting establishments with unprecedented challenges and we recognise the current pressures they are facing.
During this emergency period, it is likely that Designated Individuals (DIs) will have to adapt quickly to changing circumstances or...
During this period, it is likely that Human Application establishments will have to adapt quickly to changing circumstances, whether as a result of staffing or supply chain issues.
A list of qualifying regulatory provisions and a summary of non-qualifying regulatory provisions for the reporting period 8 May 2015 to 8 June 2017 can be found below:
HTA Regulator Qualifying Regulatory Provisions Summary
Under the Enterprise Act 2016, the HTA and all other statutory regulators have a duty to report against the Government’s Business Impact Target. The target for the 2015-2020 Parliament is a £10 billion reduction in the cost of regulation to business.