Licensing and authorisations

The HFEA has responsibility for licensing all clinics and establishments in the UK who carry out IVF and human embryo research. We can issue a number of different licences, depending on which activities you want to carry out. For example, if you are a clinic that wants to carry out IVF or associated treatments will need to obtain a ‘Treatment and storage’ licence. If you want to extend or change the range of activities you carry out, you would need to apply to vary your licence.

The main types of licences are:

  • Storage
  • Treatment – for clinics offering IUI and other basic fertility treatments which do not involve the creation of embryos
  • Treatment and storage – for clinics offering IVF, ICSI and gamete and embryo storage 
  •  Treatment (including embryo testing) and storage – for clinics offering IVF, ICSI, gamete and embryo storage and embryo testing 
  • Research – for laboratories carrying out research on human embryos

Authorised processes and conditions

You will also need to ensure that, the particular technical processes you use to carry out each licensable activity (e.g semen preparation; IVF/ICSI; egg freezing) has been authorised by the HFEA. If you want to add a novel process to this list (e.g. a new way of storing embryos), you would need to submit an application to the HFEA to add this novel process to the authorised list.

If you have an embryo testing programme, you will also need to ensure that any medical conditions you wish to test for have been authorised by the HFEA. If you want to test for a condition that is not on the list, you would need to submit an application to the HFEA.

 

What you need to know - guidance and legislation

Ensure your clinic is operating to the law - before you apply for a treatment and storage or research licence, make sure you are familiar with all the relevant legislation and guidance.

...see guidance and legislation


Treatment and storage licences

Find out the steps involved in applying for an HFEA treatment and storage licence. From making your initial application, to your clinic inspection to the final HFEA committee desicion.

...applying for a treatment and storage licence


Research licences

Find out the steps involved in applying for a licence to undertake research projects involving the use of human embryos. From making your initial application, the inspection of your clinic and how the HFEA decides to grant or deny applications.

...applying for a research licence

 


Vary your licence

Find out how to change the conditions of your existing treatment and storage or research licence.

...vary your licence

 


Closing your clinic

What to do when you want to shut down your fertility clinic - what needs to be done with your patient records and stored material.

...closing your clinic


Licence fees

Find out what fees must be paid to the HFEA for treatment, storage, research and variations of your licence.

...about licence fees

Page last updated: 02 April 2014

Guide to licensing - legislative framework

The HFEA is required to give guidance to licensed centres about the proper conduct of activities carried out in pursuance of a licence.

To access the complete legislative guide to licensing treatment, storage and research centres, read the HFEA’s legislative guide to licensing:

Code of Practice online

HFEA code of practiceGet up to date information from the 8th Code of Practice quickly with easy
navigation and an improved search.

 

...read the 8th Code of Practice

Persons Responsible

copyright 5AM Images Fotolia.comThe law requires licensable activity to take place only under the supervision of a Person Responsible.

An individual can be appointed as the PR only with the approval of the HFEA. That person must complete the Person Responsible Entry Programme (PREP) assessment before the HFEA can consider whether or not to approve them.