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Changes to your licence

This section provides details on how to make changes to your licence.

How to make changes to your contact details

It is important that the HTA is able to contact the Designated Individual (DI) and Licence Holder (LH).  If your contact details change please let us know.  You can email any changes to licensing.enquiries@hta.gov.uk

How to make an application for a licence variation

Applications can be made to vary a licence by either the Designated Individual (DI) or the Licence Holder (LH). The HTA can also vary a licence and will do so by issuing a notice of proposal to the LH and, if different, the DI.  The HTA does not plan to charge separately for these minor licence variations as they are subsumed within the annual fee.  However, the applications for licence variations are subject to evaluation and consideration by a Licensing Panel and may be refused if there is insufficient reason to make the changes requested.

Establishments storing tissue and cells for therapeutic use are licensed both under the Human Tissue Act (the Act) and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Regulations 2007) and should make an application for a variation using only the forms under  the Regulations 2007.  All other establishments should make an application using the forms under the  Act.

The following changes to a licence constitute the most common licence variations:- 

Change of Designated Individual

If you need to replace the DI due to a change of circumstances, for example change of staff, incapacity, ill health or long term suspension from duties pending an investigation, you will need to download and complete one of the forms below.

Application to vary a licence to replace the DI under the Act
Application to vary a licence to replace the DI under the Regulations 2007

Change of Licence Holder

If you need to replace the Licence Holder due to a change of circumstances, for example change of staff, incapacity, ill health or long term suspension from duties pending an investigation, you will need to download and complete one of the forms below.

Application to vary a licence to replace the Licence Holder under the Act
Application to vary a licence to replace the Licence Holder under the Regulations 2007

Change of Corporate Licence Holder

If due to change of circumstances you need to replace the Corporate Licence Holder with another corporate body or replace an individual Licence Holder with a Corporate Licence Holder, you will need to download and complete one of the forms below.

N.B. If you need to replace the named contact on behalf of the Corporate Licence Holder you will need to notify the Regulation Department in writing either by email or mail.

Application to vary a licence to replace the Corporate Licence Holder under the Act
Application to vary a licence to replace the Corporate Licence Holder under the Regulations 2007

Minor changes to premises

If you are making a minor amendment to the premises, for example, an addition of a room to the existing site, you will need to download and complete the form below.

Application to vary the licence to reflect minor change to premises

Major changes to a licence

The addition of a new licensed activity, move to a new building replacing the existing set of premises or a significant change to premises (e.g. installation of clean air facilities) will need a new licence/s rather than a change to the existing licence/s.  In this situation the DI and LH will need to complete a new compliance report licence application.  This must be considered at the time the proposed work is being planned so that the time needed for completion of the compliance report and its evaluation by the HTA is factored into the project. If you are making a major change to your licence and therefore completing a new application, please email licensing.enquiries@hta.gov.uk prior to submission.

Information for DIs at establishments licensed for post-mortem activities

One of the HTA’s key strategic aims is not to hold up tissue-based research. In this regard, the HTA have written to all Designated Individuals (DIs) at establishments licensed for post-mortem activities to advise them to apply for the removal licence, ensuring that tissue can be obtained following a post mortem for the use of research. Download a copy of this letter.

 

See also