NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

when were the MIA regulations to permit global exports announced and made effective?

1 July 2021? I haven’t seen any new regulations, but I’m not sure if this only applies to starting materials for ATMPs, or also includes the finished product.

Importing and exporting human tissues and cells if you are an establishment based in Great Britain

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

This requirement came into force on 1 July 2021.

Human application means using human tissues or cells on or in a human recipient. This includes use in extracorporeal applications. It excludes the use of an autologous graft within the same surgical procedure.

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

If you think these changes apply to you, please contact us to discuss your activities.

Who is affected
New import or export licences

https://www.hta.gov.uk/guidance-professionals/uk-transition-guidance/importing

Apply for a licence
See our Human Application sector licence forms for import and export

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LAST UPDATED ON 13 SEP 2021
New import or export licences
The HTA-related licensing changes introduced at the end of the UK Transition Period affect some establishments that previously did not require an HTA licence for importing or exporting human tissues and cells for human application.

Examples of human application include:
* the use of 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.

If you import tissues and cells from the EEA for human application or export such material to the EEA for this purpose, you will need an HTA licence to carry out this activity.

This requirement came into force on 1 July 2021.

To apply for a new HTA licence, please visit our Human Application sector licence form page. Alternatively, please contact us so that we can understand your activities and provide you with advice.

https://www.hta.gov.uk/guidance-professionals/uk-transition-guidance/importing/new-import-or-export-licences

Human Application sector licence forms
 
Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations), the HTA licenses and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human application.

More information can be found on our Licensing under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Q&S Regulations) page.
Information on licence fees can be found on our Licence fees and payments page. 

Licensing requirements following the end of the Brexit transition period

The United Kingdom (UK) has left the European Union (EU) single market and customs union, which has resulted in regulatory changes within the UK.

These changes require some Human Application (HA) sector establishments to update their licences in order to start, or continue, to import or export tissues and cells for human application from/to the European Economic Area (EEA).

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

You can read more about the regulatory changes and the new licence requirements on our UK Transition guidance pages.

Licence application and variation forms

The HTA has issued new forms to help establishments apply for a licence or update (vary) an existing licence.

Whilst the forms all follow the same basic structure, the content has been adjusted to reflect the amount of information that needs to be submitted to support the licence application or variation across a range of licensing scenarios. 

Please use the tools below to identify the form(s) that you need to complete. If you have any HTA licensing questions, please email: [e-mail] so that we can provide you with guidance and the relevant application forms.

Establishments based in Great Britain (GB)
Click here to see Human Application sector licence forms if you are an establishment based in GB

GB LICENCE FORMS

https://www.hta.gov.uk/guidance-professionals/licensing/human-application-sector