Skip to main content

Applying for a clinic licence

If you’re setting up a new fertility clinic, you’ll need to apply to us for a licence. All clinics need a licence from us to provide fertility treatments, store eggs, sperm and embryos and carry out embryo testing. This page explains the steps involved in applying.

Getting started

If you intend to offer any fertility treatments or services regulated by the HFEA you will need to apply for a licence. This involves submitting an initial enquiry form to us and then preparing and submitting your formal application.

Before you submit your initial enquiry form, you’ll need to:

  • Decide what type of licence you want to apply for
  • Familiarise yourself with the law and our guidance
  • Ensure you have suitable premises

 

Once you’ve submitted your initial enquiry form, you’ll need to:

  • Choose a Person Responsible
  • Choose a Licence Holder
  • Prepare and submit your formal application and fee

This page explains each of these steps in more detail. You’ll also be appointed an Inspector who can advise you throughout the process.

Preparing to submit your initial enquiry form

Books on a shelf in a window

Familiarise yourself with the law

Before applying for a licence, make sure you understand our role and the relevant guidance and legislation on Clinic Portal, our dedicated website for fertility clinics and research centres.

Modern building in front of a clear sky

Suitable premises

You must have suitable facilities for providing both licensed activities and those that don’t require a licence. This includes laboratories with the appropriate air quality and private rooms for counselling.

For a full list of requirements, see our Code of Practice.

You’ll also need to make sure that your premises have local authority planning consent if required – your local district or borough council should be able to advise you.

Your local authority can also give you advice about meeting local fire safety and environmental health requirements.

Man typing on a laptop

Choose the type of licence you want to apply for

The different licence types include:

  • Storage – for clinics offering just storage of gametes and embryos.
  • Treatment – for clinics offering IUI and other basic fertility treatments which do not involve the creation or storage 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.

As a new clinic, you’ll only be entitled to a two year licence before you have to get it renewed. Once you’re an established clinic, you’ll be able to apply for a licence for up to four years.

Licensed clinics are also authorised to use certain laboratory processes in order to carry out each licensed activity. If you want to use a novel process which hasn’t already been authorised by us, you’ll need to apply to us for permission.

Complete your initial enquiry form

HFEA logo

You’re now ready to send us an initial enquiry form with details of the type of licence you want to apply for and the activities you’re going to offer.

Download the initial enquiry form from Clinic Portal, complete it and email it to us at HFEAcompliance@hfea.gov.uk

We’ll contact you when we’ve received your form and support you through the rest of the licensing process.

Next steps

Nurse smiling at camera

Choose a person responsible

All fertility clinics must appoint a person responsible (PR) who has overall responsibility for ensuring the clinic and its staff comply with the law.

The PR is in charge of overseeing the clinic’s activities, ensuring staff have an appropriate level of training to fulfil their roles and that they comply with clinic inspections. They’re also responsible for submitting paperwork, fees and data to us in a timely manner.

The full list of qualifications the Person Responsible needs to meet can be found in the Code of Practice

Before a PR can be formally appointed, they need to have successfully completed the person responsible entry programme (PREP), a self-assessment tool that ensures they have a good understanding of the relevant legislation they need to comply with.

Prepare for PREP and download the assessment form on Clinic Portal.

Person signing a document

Choose a licence holder

The licence holder can be an organisation such as a health trust or a senior member of the management team.

They are the only person who can apply to vary the licence in order to appoint another person as the person responsible. Someone other than the person responsible should therefore be chosen for this role.

Submit your application and pay the fee

Once you’re confident you’ve got everything you need, you’re ready to submit your application through the secure area of Clinic Portal.

Drop our compliance team a line on hfeacompliance@hfea.gov.uk or 020 7291 8200 and we’ll get you set up on this and talk you through the rest of the licensing process.

You’ll also need to submit the correct licence application fee. The fee is currently £500 to £750 depending on the project. All fees go towards the costs of being regulated and inspected.

What happens next?

Once we have processed your application, we’ll organise an inspection. The inspection report will be presented to our Licence Committee or Executive Licensing Panel for a decision on whether your licence should be granted.

Questions?

Contact our compliance team on 020 7291 8200 or by emailing hfeacompliance@hfea.gov.uk.

;
;

Review date: 5 July 2019