Annual activity data collection

All establishments licensed to carry out activities under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 must submit data relating to the activities undertaken and the tissue types worked with between 1 January and 31 December on an annual basis.

Submission of the data is a condition of your HTA licence. 

Data must be submitted via the HTA Portal between 9.00 am Monday 8 January 2024 and 5.00 pm on Friday 29 March 2024.

We recommend you read our guidance and prepare your data for submission before you start to complete the form. It is important that you enter accurate data as you will not be able to make changes once you have submitted the form.

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Navigating the form

Make sure you select ‘save draft’ at regular intervals when inputting your data on the same page. You can save your form at any point so you do not have to do everything in one go.

The ‘previous page’ and ‘next page’ navigation buttons automatically save information every time they are selected. This allows you to move freely between pages without losing any information. You can also review and amend the information you have completed and add more information if you need to.

Do not select forwards and backwards in your browser, as any data you have not saved will be lost.

When you have submitted the form, you will be able to download a PDF copy of the data and print the information you submitted.

Contact details and licence information

Your contact details and licence information will be automatically populated on the first page of the submission form. If these are incorrect, please update them in the ‘Edit’ section of the homepage in your HTA Portal account.

You will need to manually complete the contact name, email address and postal address for your finance department so we know who to contact regarding your fees.

Annual Activity

You will need to declare the licensable activities that your establishment undertook between 1 January  and 31 December on an annual basis.

 Please select all the appropriate boxes that apply to your establishment.

If you did not carry out any licensable activities during the year, please submit a form via the HTA Portal to declare this.

Storage for a scheduled purpose

You need to declare whether your establishment stores relevant material for a Scheduled Purpose under the Human Tissue Act 2004.

This means where you are storing relevant material that is not used for patient treatment but will be used for one of the purposes listed below:

  •  Anatomical examination
  • Determining cause of death
  • Establishing after a person’s death the efficacy of any drug other treatment administered to him
  • Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)
  • Public display
  • Research in connection with disorders, or the functioning, of the human body
  • Clinical audit
  • Education or training relating to human health
  • Performance assessment
  • Public health monitoring
  • Quality assurance
Submitting your data

Please ensure you familiarise yourself with the annual activity questions about the different licensable activities. Inaccurate information could result in your establishment being charged incorrectly. 

Unless otherwise indicated, only provide data about licensable activities undertaken under the authority of your HTA licence between 1 January and 31 December of the last year.   

If you did not carry out any licensable activities last year you will still need to submit a data return. To do so you must select the appropriate tissue type and input ‘0’ if no licensable activities were carried out.

Data must be submitted via the HTA Portal between 9.00 am Monday 8 January 2024 and 5.00 pm on Friday 29 March 2024.

Annual Activity questions

Please find the questions that form this year’s data collection by downloading the spreadsheet below. Familiarising yourself with the questions in advance will help you to prepare your answers before submitting your data on the HTA Portal.

Declarations and submissions

Before you submit the data, you will be asked to declare that the information you have entered is an accurate statement of your establishment’s activities during the last year.

Please check your data is correct before you complete the declaration and click ‘submit’.

It may take a few seconds for the next page to populate, but please wait until you see the successful submission message which confirms we have received the data before you log out.


EEA: The European Economic Area (EEA) consists of the 27 Member States of the European Union in addition to Iceland, Norway and Liechtenstein. Find out more on

SLA: Service Level Agreement: This is an agreement between two HTA-licensed establishments.

TPA: Third Party Agreement: An agreement in writing between a Licence Holder (LH), or the DI on behalf of the LH, and another person or corporate body who does not hold an HTA licence for human application.

Step-by-step guide to submitting your annual activity data
Starting material for Advanced Therapy Medicinal Products (ATMPs)

If you have carried out licensable activities, such as procurement and testing, for the purposes of generating the starting material for an ATMP, please choose the relevant tissue type with ATMP in brackets from the available list. For example, if you procured adipose tissue as the starting material for an ATMP, please select ‘Adipose (ATMP)’ from the list of tissue types.

Please complete a new annual activity sheet for each tissue type that you have worked with as the starting material for an ATMP.

Acellular tissue

If you buy acellular tissue and store it for end-use only - i.e. you are not a distributor of such products - please do not submit a return for any of these tissue types.


Count each artery and vein as a separate unit.

Patches or conduits

For patches or conduits, please treat these as separate tissue types and complete a form for each. 

Guidance on tissue types

You will need to verify the tissue and cell types that your establishment worked with between 1 January and 31 December of the last year.  

Please select all the boxes that apply to your establishment.

Logging into the portal

Only authorised users can use the HTA Portal to securely submit their annual activity data. The portal can be accessed by a link at the top of this website.

Your username will be the name created when you first registered. Please test your access to the HTA Portal as soon as you can to prevent any delays in submitting your data.

If you have forgotten your password, you can reset it using the ‘Request new password’ link.

Image of login page for the HTA portal

Registering a new account

If you have never logged into the HTA Portal before, you will need to register as a new user.

To register for a new account, click the ‘Create new account’ link on the welcome screen.

Registration is simple but your account will need to be verified and linked to your licence by HTA staff. This will only take place during the HTA’s office hours, which are Monday to Friday 9 am to 5 pm.

Please allow one working day for this to happen.

Managing your user account

Once you have logged into the HTA Portal, you will be taken to the home page which is personalised depending on the licensed activities along with some guidance. You can access this page at any time by clicking on the HTA logo or by clicking home.

Once you have registered for an account, you are advised to change your password after you have logged into the Portal. To change your password or amend any of your user account details, click on ‘Edit’. In order to change your password, you will need to provide your current password.

Image of the welcome page of the HTA portal
Your licence information

You will be able to review the details we hold for any licences which you are authorised to view.

Licence numbers can be found on the top row of the page.

By clicking on the number, you will be able to see the details we hold about the licensed premises, the Designated Individual, Persons Designated and any satellite sites.

image of licencing page of the HTA portal
HTA portal user guide
Annual activity data questions


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