Application form for establishments in the
Human Application sector
We license organisations that treat patients with human tissue and cells, including stem cells, skin and heart valves. The use of human tissue to treat patients is referred to as human application. A licence for human application can be issued to a wide variety of organisations, including eye banks, maternity units and organisations that store skin and bone.
If you use human tissue to treat patients you can apply for a licence using this application form.
Guidance on completing this form and further information about licensing is available on the HTA website.
Click here for further information about the role and responsibilities of Designated Individuals and Licence Holders under the Human Tissue Act.
Click here for more information about the role and responsibilities of Designated Individuals and Licence Holders under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Establishment InformationName of establishment to be licensed
Address of establishment to be licensed / Postcode:
Please provide names of the proposed Persons Designated for the licence if the establishment is applying for a licence on one premises
Activities to be licensed under the Human Tissue Act 2004 / Section 16(2)(e)(ii) - The storage of relevant material which has come from a human body for use for a scheduled purpose, other than transplantation
Activities to be licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 / Procurement
Testing
Processing - If you are applying to undertake Processing activity please also complete a Preparation Process Dossier by clicking here.
Storage
Distribution
Import
Export
What tissues and/or cells are procured, tested, processed, stored, distributed, imported and exported? / Pericardium
Arterial vessels
Other cardiovascular
Bone
Stem Cell Lines
Tendons
Meniscus
Skin
Cornea
Sclera
Ocular Limbal Stem Cells
Amnion
Bone Marrow
Peripheral Blood Stem Cells
Cord Blood
Donor Lymphocyte Infusions
Other Stem Cells
Other – please describe:
Is the establishment responsible for donor selection? / Yes No
Is the establishment responsible for obtaining consent? / Yes No
Is the establishment an end user of the tissue and/or cells? / Yes No
Distribution / Local
Regional
National
European Community
European Economic Area (EEA) states
Other international destination(s) outside EEA
Other – please describe:
How many staff members are involved in carrying out the licensable activity/ies at the main site?
Are you storing relevant material for research? / Yes No
If yes, please provide a brief synopsis of what material is stored, the amount of material stored and who is using the material.
For each tissue or cell type please state how many units on average are procured, tested, processed, stored distributed and imported/exported each year.
Please continue on separate sheets if necessary. / Tissue type: / Usage: / Average number of units:
Procured
Processed
Stored
Distributed
Imported
Exported
Tested
Procured
Processed
Stored
Distributed
Imported
Exported
Tested
Procured
Processed
Stored
Distributed
Imported
Exported
Tested
Procured
Processed
Stored
Distributed
Imported
Exported
Tested
To assist the Human Tissue Authority, please provide a synopsis describing:
- The activities taking place
- How long the activities have been taking place
- How the facility is used
- How the facility is controlled
- How the facility relates or interacts with other establishments
Please state and describe anyserious adverse events and reactions which have occurred in the establishment in the past 12 months:
Serious adverse events
Serious adverse reactions
Establishment Accreditations
Does the establishment have any form of professional accreditation? (Such as CPA) / Yes No
If yes, please complete the questions below for each accreditation. Please continue on separate sheets if necessary.
Accrediting body:
Date accredited:DD/MM/YYYYDate enrolled:DD/MM/YYYY
Awaiting assessment? Yes No Conditional approval date:DD/MM/YYYY
Any further information, such as explanation of the activities covered by the accreditations:
Accrediting body:
Date accredited:DD/MM/YYYYDate enrolled:DD/MM/YYYY
Awaiting assessment? Yes No Conditional approval date:DD/MM/YYYY
Any further information, such as explanation of the activities covered by the accreditations:
Accrediting body:
Date accredited:DD/MM/YYYYDate enrolled:DD/MM/YYYY
Awaiting assessment? Yes No Conditional approval date:DD/MM/YYYY
Any further information, such as explanation of the activities covered by the accreditations:
Accrediting body:
Date accredited:DD/MM/YYYYDate enrolled:DD/MM/YYYY
Awaiting assessment? Yes No Conditional approval date:DD/MM/YYYY
Any further information, such as explanation of the activities covered by the accreditations:
Satellite Sites
To be completed by the Designated Individual
Does the establishment have any satellite sites? / Yes No
If yes, please complete the below information for each satellite site. If you have more than two satellite sites you can copy and paste this part of the form onto a separate sheet.
Satellite 1
Name:
Address:
Postcode:
Activities to be licensed under the Human Tissue Act 2004 / The storage of relevant material which has come from a human body, for use for Scheduled Purposes other than transplantation under the Human Tissue Act 2004
Activities to be licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 / Procurement
Testing
Processing
Storage
Distribution
Import
Export
Person(s) Designated at the site / Job title / Email address / Telephone number
Primary:
Additional:
Additional:
When did the site become operational? (approximate date)
Is the satellite under the same governance as the main hub? / Yes No
Please explain how the satellite site links to the governance of the hub
To assist the Human Tissue Authority, please provide a short synopsis describing the activities carried out at the satellite on behalf of the establishment
How does the DI intend to supervise the activities at the satellite site?
How many staff are involved in carrying out the licensable activity at the satellite site?
Please explain what responsibilities the staff at the satellite site have for meeting the consent requirements of the Human Tissue Act and Codes of Practice
Does the satellite store relevant material on behalf of any organisation other than the hub? / Yes No
If yes, please provide details.
Does the satellite supply or use relevant material for research purposes? / Yes No
Please state how many adverse events have occurred at the satellite in the last year
Does the satellite have any form of accreditation, such as CPA, MHRA, JACIE, ISO etc? / Yes No
If yes, please provide the following information for each accreditation:
Accrediting body:
Date accreditation obtained:
Current status:
Any further information:
For each tissue type please state how many units on average are procured, processed, stored, distributed and imported / exported by the satellite each year.
Please continue on a separate sheet if necessary. / Tissue type: / Usage: / Average number of units:
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Name of person who completed this form (must be either the DI or LH from the hub): / Date: DD/MM/YYYY
Satellite 2
Name:
Address:
Postcode:
Activities to be licensed under the Human Tissue Act 2004 / The storage of relevant material which has come from a human body, for use for Scheduled Purposes other than transplantation under the Human Tissue Act 2004
Activities to be licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 / Procurement
Testing
Processing
Storage
Distribution
Import
Export
Persons Designated at the site / Job title / Email address / Telephone number
Primary:
Additional:
Additional:
When did the site become operational? (approximate date)
Is the satellite under the same governance as the main hub? / Yes No
Please explain how the satellite site links to the governance of the hub
To assist the Human Tissue Authority, please provide a short synopsis describing the activities carried out at the satellite site on behalf of the establishment
How does the DI intend to supervise the activities of the satellite site?
How many staff are involved in carrying out the licensable activity at the satellite site?
Please explain what responsibilities the staff at the satellite site have for meeting the consent requirements of the Human Tissue Act and Codes of Practice
Does the satellite store relevant material on behalf of any organisation other than the hub? / Yes No
If yes, please provide details.
Does the satellite supply or use relevant material for research purposes? / Yes No
Please state how many adverse events have occurred at the satellite in the last year
Does the satellite have any form of accreditation, such as CPA, MHRA, JACIE, ISO etc? / Yes No
If yes, please provide the following information for each accreditation:
Accrediting body:
Date accreditation obtained:
Current status:
For each tissue type please state how many units on average are procured, processed, stored, distributed and imported / exported by the satellite each year.
Please continue on a separate sheet if necessary. / Tissue type: / Usage: / Average number of units:
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Procured
Tested
Processed
Stored
Distributed
Imported
Exported
Name of person who completed this form (must be either the DI or LH from the hub): / Date: DD/MM/YYYY
Third Party Information
To be completed by proposed Designated Individual for each third party agreement.
Do any third parties carry out procurement, processing, testing, distribution, import or export of tissues and/or cells on the establishment’s behalf? / Yes No
If yes, please complete the below form for each third party agreement.
If no, please move on to complete the Designated Individual section.
Third party organisation name / Name:
Address of third party premises where activity/ies take place / Address:
Postcode:
Name of third party contact
Job title
Employing body or organisation
Telephone
Is there an agreement in place with the third party? / Yes No
What was the start date of the agreement?
Does the agreement have an end date?
How often is the agreement reviewed?
Activity/ies relating to tissues and/or cells for human application which are taking place under the third party agreement / Procurement
Testing
Processing
Distribution
Import
Export
Is the establishment licensed by the Human Tissue Authority for the activity/ies it carries out on your establishment’s behalf? / Yes No
If yes, please state the Human Tissue Authority licensing number and do not answer the accreditation questions below.
Licensing number:
If no, please answer the accreditation questions below.
Does the third party who is carrying out the activity/ies on behalf of the establishment have the following accreditations? / Procurement
JACIE accreditationYes No
If yes, please state:
Date of accreditation: DD/MM/YYYY
Date of last reaccreditation: DD/MM/YYYY
Donor testing
CPA accreditationYes No
If yes, please state:
Date of accreditation: DD/MM/YYYY
Date of last reaccreditation: DD/MM/YYYY
Processing
JACIE accreditationYes No
If yes, please state:
Date of accreditation: DD/MM/YYYY
Date of last reaccreditation: DD/MM/YYYY
CPA accreditationYes No
If yes, please state:
Date of accreditation: DD/MM/YYYY
Date of last reaccreditation: DD/MM/YYYY
CPA conditional accreditationYes No
If yes, please state:
Date of conditional accreditation: DD/MM/YYYY
Date of last reaccreditation: DD/MM/YYYY
Other
Other accreditation(s)Yes No
If yes, please state the type(s) of accreditation, the date(s) of accreditation (and reaccreditation where appropriate) and detail how the accreditation relates to the licensable activity/ies.
To assist the Human Tissue Authority, please provide a short synopsis describing the activities carried out at the third party premises on behalf of the establishment
How have you assured yourself that the third party premises are fit for purpose?
Does the third party agreement specify the minimum requirements for the validation and maintenance of equipment? / Yes No
Does the third party agreement ensure that the third party has procedures for all aspects of the activity they are carrying out? / Yes No
If the third party has access to patient records, is there a system to ensure confidentiality? / Yes No
What system is there to ensure that the third party reports serious adverse events or reactions to the establishment and the Human Tissue Authority?
What systems are there to ensure that the third party could recall any tissues and/or cells if required?
If the third party is importing on behalf of the establishment, how does it ensure that the tissues and/or cells meet the Human Tissue Authority’s standards on quality and safety of tissues and cells?
If the third party is transporting material on behalf of the establishment, how does it ensure that the tissues and/or cells are maintained under the correct conditions?
What arrangements are there for the third party to provide information on the number and types of tissues and/or cells it is procuring, testing, processing, distributing or importing/exporting on behalf of the establishment?
Name of person who completed this form: / Date: DD/MM/YYYY
Application to be Designated Individual (DI)
To be completed by proposed DI.
Title
Forenames
Surname
If you have been known by another name, please provide details
Correspondence address / Postcode:
Telephone
Fax
Job title
Have you ever applied to be a DI for another establishment? / Yes No
If yes, please provide the establishment name and the application reference number.
Educational and/or professional qualifications (please include details of any diploma, certificate or degree or other evidence of formal qualifications in the fields of medicine or biological science and any other academic qualifications)
Membership of relevant professional bodies and registration numbers where applicable
Details of any other relevant experience, including practical experience in the fields of medicine, biological science, managerial experience and training
With regard to the organisational structure of the establishment, please indicate the lines of responsibility between the DI and any persons working under the licence
Please explain your involvement in ensuring that staff who will work under the licence are appropriately qualified and trained in techniques relevant to their work and that they are continuously updating their skills
Please explain your involvement in governance and quality management activities within the establishment
Please explain why you think you are suitable for the role of DI
Declaration by proposed Designated Individual
Any person making an application and submitting a compliance report should be aware that under paragraph 7(2)(a) of Schedule 3 of the Human Tissue Act 2004, the Human Tissue Authority may revoke a licence if it is satisfied that any information given for the purposes of the application for a licence was in any material respect false and misleading.
I understand the terms and conditions under which a licence will be granted under the Human Tissue Act 2004 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007, particularly my duties under Section 18 of the Act and Regulation 12 of the Regulations and confirm:
a)I will follow the guidance set out in the Codes of Practice produced by the Human Tissue Authority and as amended from time to time. / Yes No
b) The licensed activity(ies) will be carried out under my supervision. / Yes No
c) I accept I am responsible for securing that the other persons to whom the licences apply are suitable persons to participate in the carrying out of the licensed activity(ies). / Yes No
d) I accept that I am responsible for securing that suitable practices are used by the persons under my supervision in the course of carrying out the licensed activity(ies). / Yes No
e) I accept I am responsible for compliance with the conditions of any licence(s) granted. / Yes No
f) I accept that I, the Licence Holder and the establishment must comply with any Directions issued by the Human Tissue Authority from time to time. / Yes No
g) I acknowledge that the requirements of any Directions issued by the Human Tissue Authority from time to rime represent suitable practices in the course of carrying on the licensed activity(ies). / Yes No
h) I accept that I am responsible for compliance with the conditions of any and all third party agreements entered into by or on behalf of the Licence Holder in relation to the licensed activity(ies) authorised to be carried out under my supervision. / Yes No
i)I accept that I am responsible for securing compliance with the requirements of Regulation 13(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 regarding information and confidentiality. / Yes No
j) The information provided is true and accurate to the best of my knowledge. / Yes No
k) I consent to be the Designated Individual for the licence application made by the proposed Licence Holder and, where applicable, consent to be the Licence Holder. / Yes No
Name: / Date: DD/MM/YYYY
Application to be Individual Licence Holder (LH)
(if different from DI)
This section is to be completed when an individual person is applying to be the LH. If a corporate body is applying to be the LH please move on to the next section.
Title
Forenames
Surname
If you have been known by another name, please provide details
Telephone
Fax
Correspondence address if different from licensed premises / Postcode:
Job title
Employing body or organisation
Educational and/or professional qualifications
Membership of relevant professional bodies and registration numbers where applicable