HFEA.gov.uk uses cookies to deliver content and make improvements to the website. Accept Configure Menu toggle 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 Click to show and hide content 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. Click to show and hide content 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. Click to show and hide content 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 Click to show and hide content 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 Click to show and hide content 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. This PR role description sets out the behaviours we expect to see PRs demonstrate. 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. PR qualifications has insight into the scientific, medical, legal, social and ethical aspects of the clinic’s work has a formal qualification in the field of medical or biological sciences or nursing has at least two years’ practical experience in relevant fields has successfully completed the PREP Click to show and hide content 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. We aim to process 90% of applications within four months. Click to show and hide content 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. Application checklist Do you know what treatments you want to offer? Have you decided when you will start offering treatments? Do your premises meet the required standards? Are you familiar with the relevant legislation and guidance? Has a person responsible, licence holder and other relevant staff been recruited? Has the nominated person responsible completed the PREP and included their assessment as part of the submission? Questions? Click to show and hide content Where next? Clinic Portal Applying for a research licence How we regulate ; ; Review date: 3 November 2023 Send to a friend Print this page Follow us on Twitter Opens in new window Get in touch Facebook Opens in new window Get information Find a Clinic Treatment options Donors and donation Fertility preservation About the HFEA News and press releases Privacy, cookies and accessibility Accessibility statement Freedom of information Complaints Work for us For clinics Clinic Portal Applying for a clinic licence Applying for a research licence PGT-M conditions Research and data Our data Guide to the anonymised register Research publications