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All establishments licensed under the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 must review their licensing records and complete a compliance update.The information collected will be used to:
Please read this guidance document and prepare your data for submission. It is important that you enter accurate data as you will not be able to make changes once you have submitted the form. We recommend you consider gathering data in advance by sharing this document with your colleagues.
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:
You should read the relevant guidance document before you start to fill in the application form.
The guidance documents will tell you:
The guidance will help you to decide whether you need a licence. The guidance will also help you determine which licence you need and the licensable activities it should cover.
You can find information about how to meet the requirements of the Regulations in our documentary framework.
Codes of Practice
Introduction to the Regulations
The Quality and Safety of Organs Intended for Transplantation Regulations 2012 transpose the European Union Organ Donation Directive (EUODD). The purpose of this Directive is to establish standards for the quality and safety of organs intended for donation...
Two new EU Directives are being put in place for the coding and import of tissues and cells for human application. These Directives are in force throughout the EU but have not been transposed into the UK law. When implemented, all establishments licensed in the human application sector will need...
Licensable activities
Under the Q&S Regulations, the HTA licences and inspects establishments that undertake the following activities using tissues and cells intended for human application: