Human Tissue Authority

The regulator for human tissue and organs

Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended)

    Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.

    What activities need a licence under the Regulations?

    The activities of import and storage of human tissues and cells for human application can only lawfully take place if the establishment is licensed to carry out these activities. However, the following activities may lawfully be carried out either under a licence or under a third party agreement with an establishment licensed to carry out activity/ies relating to tissue and cells for human application:

    • Procurement
    • Testing of donor samples
    • Processing
    • Export
    • Distribution

    N.B. Anyone carrying out the above activities and storing material for more than 48 hours must be in possession of a storage licence.

    Do I need a licence if I am only procuring and not storing tissues and cells for human application?

    If you are procuring on behalf of an establishment that has a licence to procure tissues and cells for human application and you have a third party agreement in place with them to carry out this activity, you will not require your own HTA licence. Otherwise, a licence will be required to carry out this activity.

    Who will I need to have third party agreements in place with?

    You will need the third party agreements with anyone who:

    • carries on a licensed activity (other than import or storage), on behalf of the licensed establishment; or
    • supplies to the licensed establishment any goods or services which may affect the quality or safety of tissue or cells.
    What standards are third party agreements regulated by?

    The HTA has issued a Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by Directions (Directions 001/2021) setting the standards for third party agreements.

    If I store tissues or cells for human application for less than 48 hours do I require a licence under the Regulations?

    If you are only storing tissues or cells for human application and they are stored for less than 48 hours a licence is not required. Please note if you carry out any of the activities listed below then they will need to be carried out under a licence or a third party agreement with an establishment licensed to carry out activity/ies relating to tissues and cells for human application by the HTA:

    • Procurement
    • Testing of donor samples
    • Processing
    • Export
    • Distribution

    N.B. as with storage, the activity of import can only lawfully take place if the establishment is licensed to carry out this activity.

    Does the HTA regulate donor lymphocyte infusions (DLIs)?

    Yes, the HTA regulates the procurement, processing, storing, donor testing, distribution and import / export of DLIs.

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