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Licensing and inspections

The HTA licenses more than 800 organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions.

Following a review of regulatory methodology, which included feedback from the licensed sectors, we have moved from a fixed-term to a continuous licensing system. Fixed-term licences will now only be issued in exceptional cases, for example to temporary mortuaries, temporary exhibitions and establishments that we deem to be a high risk.

The continuous licensing system is supported by a new sector-specific compliance monitoring framework that involves the collection of regular compliance updates from licensed establishments. We will inform you of the method by which the compliance information will be collected in due course.

We also conduct inspections to check that licensed establishments maintain good standards and follow appropriate procedures.

Professionals can use this section to find out more about HTA licensing and inspections, serious adverse event reporting, plus HTA regulatory alerts.

If you have any questions about licensing or inspections, please email or phone 020 7269 1900 and ask to speak to a member of the regulation directorate.

  • People at licensed establishments

    Each licensed establishment has to nominate a person, the Designated Individual, who will supervise the activities being carried out. Each establishment also has a Licence Holder that oversees the licence. This page provides information for these people.

  • List of licensed establishments

    Take a look at which establishments hold an HTA licence.

  • Inspections

    Find out more about being inspected by the HTA.

  • Inspection reports

    An HTA inspection report is completed following an inspection of a licensed establishment. It includes background information about the activities being carried out and an indication of what standards were found not to be fully met.

  • Regulatory alerts

    Take a look at regulatory alerts from the HTA and find out what to do if you are affected.

  • Fees and payments

    To reflect the amount of work involved in evaluating each licence application, plus providing advice and guidance before a licensing decision is proposed, you will be charged for a full business year regardless of when you apply. Find out about HTA fees and how to pay for a licence.

  • Consent exemptions

    Find out if you need a licence from the HTA or if your work requires consent.

  • Licensing under the Quality and Safety Regulations

    Here you will find information on the licensing requirements under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations).

  • Satellite premises

    Satellite sites are small premises under the same governance processes as a larger establishment with the same Designated Individual. Find out more about satellite sites.

  • Licence application guidance

    Use our straightforward guide to apply for a licence.

  • Emergency mortuaries

    A mass fatality incident may result in the need for an emergency temporary mortuary. Find out how to prepare, what to do if an emergency temporary mortuary is needed and what to do after the event.

  • Reporting to the HTA

    The HTA has an online system for the reporting of any serious adverse events and/or reactions that are linked to the tissue and cells for patient treatment (human application) sector and HTA-licensed establishments in the post mortem sector are required to notify the HTA of serious untoward incidents.

  • Licensing under the Human Tissue Act

    Here you will find information on the licensing requirements under the Human Tissue Act 2004 [HT Act].