See also

Downloads

Distribution and import, export FAQs

Frequently asked questions for distribution and import, export under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (“the Quality and Safety Regulations”) and the HTA Directions.

What is the definition of distribution?

Distribution means transportation and delivery of tissues or cells intended for human application. A person who, from any premises, controls the provision of services for transporting tissue or cells is to be taken to distribute tissue or cells from those premises. As a minimum requirement, establishments that distribute tissues or cells must comply with the provisions of HTA Directions 001/2006 (in particular paragraphs 28, 37-40, 54, 55 and 68) and 002/2007 (in particular paragraphs 52-55).

Distribution occurs whenever an establishment has control over the transport of material, regardless of where it is going. This includes final distribution for end use and any interim distribution such as transportation for testing or processing.

When is a licence for distribution required?

Distribution within the UK either requires a licence, or is to be carried out under a third party agreement.

This includes transportation between a hub and a satellite.

Distribution of tissues or cells intended for human application to an unlicensed or non-accredited tissue establishment or other establishments, such as end users or an organisation responsible for Human Application within the European Economic Area (EEA) requires a licence, or is to be carried out under a third party agreement.

If a third party is carrying out the activity of distribution on behalf of a licensed establishment, who needs to be licensed?

The licence holder of the licensed establishment would need to have the activity of distribution on his or her licence if a third party is carrying out this activity on their behalf.

A third party agreement would need to be put in place with the third party and comply with the HTA Directions 002/2007 paragraphs 117,118 and 120-122.

What is the definition of import?

Import means import into the United Kingdom from a place outside the United Kingdom.

When is a licence for import required?

A licence is required for import when tissues or cells intended for human application are imported from any establishment in a country outside the EEA or from any unlicensed or non-accredited tissue establishment or other establishment or organisation responsible for Human Application within the EEA. (Licensed or accredited tissue establishments are those who are licensed or accredited under the laws adopted in that EEA state for the purpose of implementing the three EUTCD Directives.)

The importing establishment must ensure that imports from countries within the EEA comply with the Quality and Safety Regulations and Directions 001/2006 and 002/2007, and that imports from countries outside the EEA comply with Directions 004/2007.

What is the definition of export?

Export means export from the United Kingdom to a place outside the United Kingdom.

When is a licence for export required?

A licence is required for export when tissues or cells intended for human application are exported to any establishment in a country outside the EEA or to an unlicensed or non-accredited tissue establishment, or other establishment or organisation responsible for Human Application within the EEA. (Licensed or accredited tissue establishments are those who are licensed or accredited under the laws adopted in that EEA state for the purpose of implementing the three EUTCD Directives.)

The exporting establishment has to ensure that the exports comply with the Quality and Safety Regulations and Directions 001/2006 and 002/2007.

Can a third party carry out export on behalf of a licensed establishment?

Export can be carried out by a third party on behalf of an establishment that is licensed to carry out the activity of export. The licensed establishment would need to put in place a third party agreement in accordance with Directions 002/2007 paragraphs 117,118 and 122.

What countries make up the EEA?

For the purposes of the relevant legislation and Directions, Gibraltar is included as a member of the EEA.

You can find more information about the EEA, including a list of countries within the EEA here.

Do I need a licence to distribute and/or export tissue to a tissue establishment within an EEA (or EU) member state which has not yet implemented the Directives?

Yes. The UK licensed establishment would need to be licensed for distribution and export and should ensure that the tissue and / or cells meets the requirements of HTA Directions 001/2006 and 002/2007. 

Can I import from an unlicensed or non-accredited tissue establishment in the EEA?

This advice relates only to the import of tissue / cells from an establishment which is not accredited because the EEA state has not implemented the Directives. If the establishment is not accredited because of some other reason, e.g. it has not applied for or failed to gain accreditation, then this should be considered on a case by case basis. We advise that you contact the HTA in this circumstance.

As long as your establishment holds an import licence, it would be the responsibility of the Designated Individual and the Licence Holder to ensure that imported tissue or cells meet the relevant requirements of Directions 001/2006, 002/2007 and 004/2007. Your establishment must verify that consignments conform to these requirements upon receipt. Tissue / cells must not be released from quarantine until verification is complete. In particular, please refer to paragraph 115 of Directions 002/007 which details the traceability requirements.

Do I need a licence to import from a licensed or accredited tissue establishment within the EEA?

No. However you may require a licence to store and / or distribute the tissue or cells.

Do I need a licence to import from outside the EEA?

Yes. A licence will be required and your establishment will need to ensure that the imported tissues and cells meet the standards of quality and safety set out in the Directives, the Quality and Safety Regulations, Directions 001/2006 and 002/2007 and your establishment will also need to ensure that any imports comply with Directions 004/2007. 

How do I ensure that I meet the regulatory requirements?

This could be directly, by visiting the establishment within the source country or by auditing their processes and records, or indirectly, by entering into written agreements (Service Level Agreements) with the establishment or by putting in place standard operating procedures and quality management systems and carrying out appropriate risk assessments.
 
Would donor records need to be maintained when I import tissue from outside the EEA?

Yes. Paragraph 14 of Directions 004/2007 imposes an obligation on each establishment to maintain a record for each donor containing donor identification to include first name, family name, date of birth, age and sex and relevant information pertaining to procurement. 

Can I have a third party agreement with an establishment outside the UK?

No. You cannot have a third party agreement with an establishment outside the UK. Third Party Agreements, as provided for in the Quality and Safety Regulations, refer to only agreements between the licence holder (or Designated Individual on behalf of the licence holder) and an other person (including an establishment) within the UK.


When do HTA Directions 004/2007 apply to import and export activity?

HTA Directions 004/2007 are made to ensure compliance with Regulation 15 (1) of the Quality and Safety Regulations, to secure that all imports of tissues and / or cells intended for human application from countries which are not member states of the EEA meet standards of quality and safety, equivalent to those provided for in those Regulations.

Establishments must comply with the HTA’s Code of Practice (HTA Import and Export Code) on import and export of human bodies, body parts and tissue, as appropriate.