Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations), the HTA licenses and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human application.
More information can be found on our Licensing under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Q&S Regulations) page.
Information on licence fees can be found on our Licence fees and payments page.
Licensing requirements following the end of the Brexit transition period
The United Kingdom (UK) has left the European Union (EU) single market and customs union, which has resulted in regulatory changes within the UK.
These changes require some Human Application (HA) sector establishments to update their licences in order to start, or continue, to import or export tissues and cells for human application from/to the European Economic Area (EEA).
The changes also apply to the import and export of tissues and cells that form the starting material for Advanced Therapy Medicinal Products (ATMPs).
You can read more about the regulatory changes and the new licence requirements on our UK Transition guidance pages.
Licence application and variation forms
The HTA has issued new forms to help establishments apply for a licence or update (vary) an existing licence.
Whilst the forms all follow the same basic structure, the content has been adjusted to reflect the amount of information that needs to be submitted to support the licence application or variation across a range of licensing scenarios.
Please use the tools below to identify the form(s) that you need to complete. If you have any HTA licensing questions, please email: firstname.lastname@example.org so that we can provide you with guidance and the relevant application forms.