Human Tissue Authority

The regulator for human tissue and organs

Existing HTA licence holders

The six-month phase for Human Application sector establishments to comply with new import and export licensing requirements ends on 1 July 2021.

We are contacting HTA-licensed establishments directly regarding licence variations to include import and export activity. However, if your activities have changed since your last Annual Activity data submission, please contact us as soon as possible.

Alternatively, visit our Human Application sector licence forms page and select the variation form that applies to your activities.

Below are steps you can take to prepare for your licence variation:

Import

Importing Tissue Establishment Licence Certificates (ITELCs) are specific to the tissue type, supplier, and country of origin.

If you already hold an ITELC authorising you to import tissues and cells for human application you will need to apply to update this if you intend to receive tissues and cells for human application from a supplier based in the EEA from the 1 July 2021.

You will need to make sure that you have written agreements in place with your suppliers in the third country as set out in paragraph 255 in the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.

Importing tissue establishments must be able to demonstrate that imported tissue or cells meet equivalent quality and safety standards to those set out in the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended).

Please visit our Human Application sector licence forms page.

Export

Establishments exporting tissues and cells must demonstrate that exported tissue or cells meet the quality and safety standards as set out in the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended).

The release process should include confirmation by a suitably trained and experienced person that the material meets the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended).

The agreements with your recipient organisation(s) in the third country must set out the responsibilities of each party throughout the tissue or cell pathway, including transportation and Serious Adverse Events and Reactions (SAEARs) reporting arrangements. A written agreement must also be in place with any third party undertaking activities related to export on behalf of your establishment.

Export licences are not destination specific. Therefore, if you hold an existing export licence for the tissue type(s) in question, you do not need to update this authorisation to include recipient countries in the EEA.

Please note that if you export tissues and cells for human application to recipients in Northern Ireland (NI), the recipient organisation must hold an import licence. Please direct end users in NI to our page on Importing human tissues and cells if you are an establishment in NI and encourage them to contact us to discuss their licence requirements.  

Please visit our Human Application sector licence forms page.

 

Description: 
Information for Human Application sector establishments that import or export
Last updated on: 5 May 2021