Human Tissue Authority

The regulator for human tissue and organs

Key information for Designated Individuals

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 differing demands.

It is important for DIs to bear in mind that they have a statutory responsibility to oversee activities that fall under an HTA licence – whatever the circumstances. HTA-licensed establishments are expected to comply with wide-ranging standards and may already have existing risk assessments, monitoring systems, contingency plans and adverse event reporting systems that can be used to assess, track and manage the impacts of the COVID-19 outbreak.

Contingency arrangements for DIs

If a DI is unable to fulfil their statutory responsibilities due to absence, they must make sure that there is a suitable replacement that can carry out the duties of the DI role. If this is the case for your establishment, please contact us with details. You can find our Change of Designated Individual forms on our website.

You may be able to make temporary cover arrangements by authorising Persons Designated (PDs) to oversee the day-to-day activities of the licence and to report the investigation of incidents.

We are also aware that many HTA licence contacts may be working remotely or away from the establishment site for an extended and unknown period. If this applies to your establishment, DIs must make sure that the establishment’s quality management systems cover remote working arrangements and oversight of HTA-licensed activities.

It is important that the HTA is able to contact the DI and Licence Holder of your establishment. If your contact details change, please email licensing.enquiries@hta.gov.uk. Please also contact us if your current working arrangements are significantly different from normal and where this is impacting on activities carried out under an HTA-licence.

Changes to licensable activities and licence variations

In response to the current situation, establishments may find it necessary to undertake new licensable activities or make changes to their existing licence.

Any changes to an HTA licence must still be reported to the HTA for evaluation. Please note, we will now be issuing licence paperwork electronically.

We will fast track any licence variations made in response to COVID-19 management. If your variation request is unrelated to COVID-19, please be aware that our assessment may take longer than usual. We advise that you allow sufficient time for a variation to take place.   

Please refer to our guidance on licence variations. Any changes to your licence(s) may affect your licence fees.

Please contact our licensing team for further information: licensing.enquiries@hta.gov.uk.

Last updated on: 15 Apr 2020