UK transition licensing frequently asked questions

Establishments in Great Britain (GB)

If you are an establishment based in GB that imports or exports human tissues or cells between GB and a country in the European Economic Area (EEA), you may need a licence that covers these activities.

This requirement came into force on 1 July 2021.

This only applies if you import or export human tissues and cells for human application (patient treatment).    

Examples of human application include:  

• using bone, pericardium, and dermal tissue products in dentistry;
• bone products used for orthopaedic treatment;  
• amnion tissue products used as barriers in wound healing;   
• skin grafts used to replace damaged skin tissue; and
• corneal grafts used in ocular surgery. 

Please note that the above list is not exhaustive and other activities may be affected.

The changes also apply to the import and export of tissues and cells that form the starting material for Advanced Therapy Medicinal Products (ATMPs).

For more information on which establishments and activities are affected, please visit our page on Importing and exporting human tissues and cells if you are an establishment based in Great Britain

Establishments in Northern Ireland (NI)

Since 1 January 2021, establishments in NI that import tissues or cells from GB need to hold an HTA licence that covers this activity. Establishments in NI need to treat suppliers in GB as third country suppliers. This means that if you are an establishment in NI receiving tissues and cells for human application from a GB supplier, you will need: 

• an HTA import licence; and 
• an agreement with the supplier in GB.  

In line with the UK government’s commitment to unfettered access, there are currently no additional requirements to export tissues or cells to GB. 

There are no additional requirements for NI establishments to import or export tissues or cells from or to the EEA.  

For more information, please visit our page on Importing tissues and cells for human application if you are an establishment in Northern Ireland.

The HTA licenses premises, not individuals. The premises where licensable activities are taking place must hold an HTA licence, under the oversight of a Designated Individual (DI) who is responsible for ensuring suitable practices take place under the licence.

For more information, please visit our page on Licensing under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Q&S Regulations)

Please visit our Human Application sector licence forms page. Alternatively, you can contact us: licensing.enquiries@hta.gov.uk.

Importing Tissue Establishment Licence Certificates (ITELCs) are specific to the tissue type, supplier and country of origin. Therefore, if you already hold an authorisation 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.

If your establishment requires an HTA import or export licence, as a result of our departure from the EU, you are not required to pay a licence fee for these activities in 2021/22. The HTA will announce 2022/23 licence fees in December 2021.

An importing tissue establishment (ITE) is an organisation based in the United Kingdom which holds an HTA licence for import. The ITE will be party to a contractual agreement with a third country supplier (3CS) for the import of tissues and cells. The ITE is also responsible for ensuring the quality and safety of tissues and cells are equivalent to those distributed from within the United Kingdom.

An organisation offering brokerage services will normally be an ITE importing tissue establishment if:

• it is party to a contract with a 3CS; and
• it has responsibility for verifying the quality and safety of the tissues and cells.

If another organisation is responsible for ensuring the quality and safety of the imported tissues and cells, it will need to hold an import licence.

End users in GB returning tissue and cell products for human application to any third country supplier will require an export licence that covers this activity.

An export licence is not required if tissue and cell products are returned for disposal or investigation, provided there is no possibility of future human application. 

Establishments in Northern Ireland (NI)

If you are ordering human tissue and cell products from an HTA-licensed establishment based in GB, you will require an import licence and an agreement with the supplier for this activity. The requirement has been in place in since 1 January 2021.

Establishments in Great Britain (GB)

If you are ordering tissue and cell products from an HTA-licensed establishment in the UK, you do not need an import licence.

If the tissue and cell product originated from a third country, then the establishment that imported the product from the third country is responsible for holding the import authorisation and ensuring the regulatory requirements for import are met.

The HTA regulates establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human use. This includes any steps involved in the handling of tissues and cells prior to them being manufactured into medicines.

Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regs), the import and export of tissues and cells from or to a tissue establishment in a third country is a licensable activity. Therefore, such import and export activities can only be undertaken by establishments licensed for import and/or export by the HTA.

The HTA considers the licensable activity of export as ensuring tissues and cells leaving the UK meet the required legislative standards. This licensing requirement applies to the export of all tissues and cells intended for use in human application, including those that will be used in the manufacture of an Advanced Therapy Medicinal Product (ATMP), where the tissues and cells are referred to as starting materials.

Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) biological samples may be required from the donor to demonstrate the quality and safety of any tissues and cells used in human application. These samples need to meet any relevant quality and safety standards set out in the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment, but can be transported into, or out of, the UK without an import or export licence.

Biosamples may be obtained for analytical purposes to provide data for a clinical trial or a research project. These types of samples are considered relevant material under the Human Tissue Act 2004 (HT Act). For the purposes of the HT Act, import and export is considered as into and out of England, Wales or Northern Ireland. This definition is unchanged following the end of the UK Transition Period.

Where import and export is taking place, these are not licensable activities under the HT Act. However, the storage of the material once it is imported may be licensable, if this is for a scheduled purpose, such as research within the scope of the HT Act.

Note that clinical diagnosis is not a scheduled purpose.

Under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended), a third country is defined as:

• in relation to the import or export of tissues or cells into, or the export of tissues and cells from, Great Britain (GB), a country other than the United Kingdom (UK);

• in relation to the import of tissues or cells into Northern Ireland (NI), a country other than NI or a European Economic Area (EEA) State; and

• in relation to the export of tissues or cells from NI, a country other than the UK or an EEA State.

Under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended), the definition of a third country supplier is:

• in relation to tissues or cells intended for import into Great Britain (GB) for human application, a person in a country other than the United Kingdom who has an agreement with an importing licence holder for exporting such tissues or cells into GB; and

• in relation to tissues or cells intended for import into Northern Ireland (NI) for human application, a person in a country other than NI or an EEA state who has an agreement with an importing licence holder for exporting such tissues or cells into NI.

Importing tissue establishments must ensure written agreements are in place with suppliers in the third country as set out in paragraph 255 in the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.

Establishments exporting tissues and cells must ensure written agreements are in place with recipient organisations in the third country, setting out responsibilities for all parties throughout the tissue or cell pathway. This must include information on transportation, traceability 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.

Written agreements with a 3CS must include a clause that guarantees the importing tissue establishment (ITE) the right to perform regular audits. The HTA may request to see a summary of an audit report as part of a site visit inspection (or virtual regulatory assessment), or at any other time as deemed necessary.  

The decision of whether to perform a remote assessment or on-site audit may be made based on risk in line with the HTA’s current approach to ITEs. Establishments will need to provide an evidence-based justification for their selected audit approach. This should include consideration of regulatory provisions within the third country, as well as the extent of activities carried out by the 3CS. 

Establishments in Great Britain (GB)

You no longer need to use the Single European Code, unless you wish to do so. You can use the traceability systems you had in place before the introduction of the Single European Code. Please refer to the Quality and safety of human organs, tissues and cells on the government website for further guidance. 

Establishments in Northern Ireland (NI)

You must continue to use the Single European Code.  

The regulatory changes following the end of the UK Transition Period only apply to human tissue and cell products imported:

• into Northern Ireland from Great Britain from 1 January 2021, or
• into Great Britain from the EEA from 1 July 2021.

Licensing requirements remain unaffected for the import of tissues and cells from outside of the EEA, where an authorised import licence is required.

Importing establishments may only carry out the import of tissues or cells from a third country supplier under the terms specified in an Importing Tissue Establishment Licence Certificate (ITELC). ITELCs are specific to the tissue type, supplier, and country of origin and are issued by the HTA to establishments authorised for import activity.

You will need to complete the embedded spreadsheet within the import application form(s) with information such as the tissue type, product name, trade name, third country supplier (3CS) details and subcontractor (SC) details (if applicable).

For more information on which licence form you need, please visit our Human Application sector licence forms page.