Human Tissue Authority

The regulator for human tissue and organs

Licensing of procurement organisations FAQs

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.

Procurement is defined by the EU Tissue and Cells Directives as a process by which tissues or cells are made available. This includes the donor selection procedure as well as the physical act of removing tissue and / or cells intended for patient treatment (human application).

If you or someone within your organisation is carrying out procurement of tissues and / or cells for patient treatment, a HTA licence will normally be required, unless the procurement is being carried out under a third party agreement. In these circumstances:

  • the procuring establishment must be acting on behalf of a licensed establishment; and
  • the third party agreement meets the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA's Directions 003/2010.

The organisation should apply to the HTA for a licence under the Quality & Safety Regulations. The HTA will work with procurement organisations applying for licences to identify deficiencies and offer advice and guidance about how best to meet them.

There are specific circumstances when you can carry out procurement under a third party agreement rather than a licence. In order to carry out procurement under a third party agreement you must:

  • be procuring on behalf of the establishment you have the third party agreement with; and
  • have a third party agreement that meets the requirements of the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA's Directions 003/2010

If you are procuring tissues or cells on behalf of a patient at your own establishment you cannot do this under a third party agreement with another licensed establishment; this is because you are procuring on your own behalf not on behalf of the licensed establishment. In this case a licence for procurement would be needed.

Procurement of tissue for human application, such as bone, skin, heart valves and corneas requires a licence for procurement from the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. There are circumstances where a procurement licence is not required and these are set out below:

  • the organisation responsible for the mortuary e.g. the Local Authority or NHS Trust, is procuring on behalf of a licensed establishment under a third party agreement; and
  • the third party agreement meets the standards set out in the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA's Directions 003/2010.

A licence for the removal of relevant material from a deceased person authorises an establishment to remove material for purposes such as research. It does not authorise the procurement of tissues and / or cells for human application.

A third party agreement is an agreement in writing between a Licence Holder (LH) or Designated Individual (DI) and another person that carries out a licensable activity on behalf of the LH / DI. The agreement needs to be made in accordance standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA's Directions 003/2010. If the licensable activity is carried out under a third party agreement as described above, the organisation carrying out that activity will not require a licence.

Licensable activities that can take place under a third party agreement include procurement, testing, processing, distribution, import and export. The activity of storage cannot take place under a third party agreement.

Procurement of tissue such as bone marrow and peripheral blood stem cells (PBSCs) requires a licence unless the procurement is being carried out under a third party agreement e.g:

  • the procuring establishment must be acting on behalf of a licensed establishment; and
  • the third party agreement meets the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA's Directions 003/2010.
  • If you are procuring bone marrow and PBSCs for patients at your organisation and sending them off-site to a licensed establishment for processing you will need a licence for the procurement. A third party agreement will not suffice because the procurement cannot be considered to be carried out on behalf of the processing establishment.

Our current licence fee for procurement organisations can be found on our fees page.

The HTA will send an invoice with your licence offer. This invoice will cover the period from the date that a licence is issued, extending up until the following 4 July. Thereafter you will normally be charged annually.

It is possible for procurement sites to be satellite sites of a licensed establishment. Satellite establishments are normally smaller premises on a separate site to the licensed establishment. The satellite establishment must be under the same governance framework as the larger licensed establishment (the hub) and supervised by the same Designated Individual (DI). The DI at the hub must have systems in place to ensure that the governance framework is properly implemented. The DI should plan to make regular visits (at least twice a year) to satellites to verify that the licensing framework and systems and processes are working in practice.

A list of licensed establishments is available on our website. Any activity carried out under a licence needs to be under the supervision of a DI. If you wish to carry out the activity of procurement at an organisation that is already licensed by the HTA you will need to contact the DI and ensure that they are willing and able to supervise the activity.

The DI has the primary (legal) responsibility under the Quality & Safety Regulations to secure:

  • that suitable practices are used in undertaking the licensed activity;
  • that the other persons who work under the licence are suitable;
  • that the conditions of the licence are complied with;
  • that the conditions of third party agreements are complied with; and
  • that all information relating to licensable activities:
    • is available for tracing donations;
    • is up to date and correct; and
    • is held securely.

The role of Licence Holder does not impose the duties that are expected of the DI, however they do have a duty to ensure amongst other things:

  • that the conditions of third party agreements are complied with;
  • that the Directions are complied with; and
  • that licence fees are paid.

It is a requirement that the DI must have:

  • a diploma, certificate or other evidence of formal qualification in the fields of medical or biological sciences; or
  • be otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications and practical experience; and
  • have at least two years' practical experience which is directly relevant to the activity to be authorised by the licence.

    The LH has the right to vary a licence. This enables them to substitute another person as the Designated Individual (DI) and allows the establishment to cover circumstances where the DI is unable or incapable of overseeing the licensable activities(s). Consequently, the HTA requires individual Licence Holders to be more senior than the DI (e.g. Medical Director / Chief Executive).

    Establishments applying as a corporate body Licence Holder should provide the contact name of an individual who will act as a representative for the corporate body. This individual should also be more senior than the DI in order to substitute the DI where necessary. The HTA has a preference for licence holders to be the corporate body.

    Yes, a licence might cover all procurement carried out within a Trust provided that:

    • they are carried out on the same premises; and
    • they are carried out under the supervision of the DI.

    No. An application for a licence must specify the premises where the licensed activity is to take place. If the licensed activity will take place in premises at more than one place, a separate licence will be needed. Premises in different streets or with different post codes will be considered as being in different places. In contrast, different buildings on a hospital site could be regarded as in the same place. The HTA will consider this on a case-by-case basis, depending on the facts in each application.

    Yes. A licence does not specify the type of tissue it relates to therefore if you have a licence to procure tissue and cells you can procure various types of tissues and cells under the authority of the licence.

    Standard condition 15 in Annex B to all HTA licences, requires the Licence Holder or the Designated Individual (DI) to notify the HTA when any new type of tissues and /or cells is to be procured, tested, processed, stored, distributed, imported or exported by the establishment. Where the processes required for this new type of tissues or cells differ substantially from those previously employed by the establishment, the DI must first notify the HTA. The new type of tissues and /or cells may not be procured, tested, processed, stored, distributed, imported or exported by the establishment until the HTA is satisfied that the establishment has suitable premises and employs suitable practices to carry out the proposed activity in respect of these tissues and /or cells.

    All activities carried out under the licence must be supervised by the DI, and the DI must have suitable qualifications and experience to supervise the complete range of tissue types covered by the licence.

    Where the storage, processing, import, export or distribution of cells or tissues (including cell lines) for patient treatment is for use in manufactured products and these activities are regulated by:

    • the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994;
    • the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994;
    • the Medical Devices Regulations 2002; or
    • the Medicines for Human Use (Clinical Trials) Regulations 2004.

    These activities will not be regulated by the HTA and a HTA licence will not be required. Note: the procurement and testing of tissues and cells will still require a licence from the HTA.

    Yes. Organisations procuring tissues and cells for human application require a licence from the HTA unless the procurement is being carried out under a third party agreement. In these circumstances:

    • the procuring establishment must be acting on behalf of a licensed establishment; and
    • the third party agreement meets the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA's Directions 003/2010.
    • If an organisation is carrying out procurement on their own behalf a licence will be required for this activity.

    In the UK, procurement of tissues and cells for human application is licensed under The Human Tissue (Quality and Safety for Human Application) Regulations 2007 which were transcribed into UK law from the European Union Tissues and Cells Directives (EUTCD). The latter is legislation that is applicable to all countries in the European Union with each country having its own Competent Authority responsible for the licensing of procurement organisations. Hence, any organisations that procure tissue for human application in Europe will be subject to the EUTCD and will require a licence from the national Competent Authority, rather than the HTA.

    If you discover an unlicensed activity please advise the relevant organisation to look at our website to find out more about our licensing processes and whether they need a licence. If they are still unclear please tell them to contact us directly for advice. If the establishment doesn't contact us and doesn't apply for a licence, you may wish to advise the unlicensed establishment that you would like to give their details to the HTA so we can contact them directly to offer more focused advice and guidance. If establishments are carrying out procurement of tissues and / or cells for human application outside the authority of a licence or a third party agreement, the HTA will take appropriate regulatory action.