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How to apply for a HFEA licence
Application forms
Initial enquiry form (60 Kb)
Application form N1 (137 Kb)
Treatment and/or storage only centres
Application form S1 (141 Kb)
Person Responsible or Nominal Licensee
Application form N1D (107 Kb)
Treatment and/or storage centres (where the existing licensed premises are moving outside the current curtilage).
How to apply for an HFEA licence
- What activities are governed by the HFEA?
- Before making an application
- Types of licences
- What happens once I apply?
- Preparation for an application
- How long will it take to become licensed?
- Decision by an HFEA Licence Committee
- Granting of a licence
- Granting of a licence subject to specific conditions
- Refusal of a licence
- Appeals procedures
- What happens once I am Licensed?
- Where can I get further information?
What activities are governed by the HFEA?
Activities which are governed by the Human Fertilisation & Embryology (HFE) Act 1990 (as amended) (and it is illegal for any person to do except in pursuance of a licence) are:
- Bringing about the creation of an embryo in vitro (embryo includes an egg in the process of fertilisation) either for treatment or research
- Keeping or using an embryo either for treatment or research
- Storing any gametes
- Using donated sperm or donated eggs in the course of providing treatment services for any woman
- Treatment involving the use of fresh partner gametes
- Non Medical Fertility Services
You need to apply to the HFEA for a licence. If you provide assisted conception services without being licensed you could be prosecuted.
An individual can apply to be the Person Responsible. Alternatively, a company, society, association, NHS or voluntary organisation may apply to be licensed as long as a named person is identified. In these cases, you will be asked to nominate an individual to be the contact person for the licence application.
Before making an application
Before making an application you will need to identify suitable premises. You should make sure that your premises have local authority planning consent if required. Advice about this can be obtained from your local district or borough council. You should tell the building Inspector based at your local authority.
Your local authority can also give you advice about meeting local fire safety and environmental health requirements.
Types of licences
Under the HFE Act, the HFEA can issue licences for treatment and/or storage, or for research.
What happens once I apply?
Once you have sent in the forms, the HFEA has to establish whether you, and any manager and staff that you wish to employ, are suitable to be licensed.
As well as these checks, an HFEA Inspector will visit your premises at least once to make sure they are suitable, safe and fit for purpose. You will be required to complete the Person Responsible Entry Programme Assessment and the Inspector will also talk to you about how you can meet the requirements of the Act, Code of Practice and the Authority's Directions.
Preparation for an application
An HFEA Inspector will guide you through the application process. It is useful for applicants to meet with relevant HFEA staff before submitting a formal application.
The majority of applicants contact the HFEA to discuss their proposals before they submit an application for a licence.
How long will it take to become licensed?
The HFEA is committed to processing 90% of licence applications within four months of receipt of a properly completed application form. It is therefore requested that application forms are not submitted until the centre is nearly ready to be inspected.
An Initial Enquiry Form is included in the pack. On receipt an Inspector will contact you to advise on the process.
Before granting a licence, the HFE Act requires the Authority to inspect the premises where the proposed licensed activities will be carried out. An inspection will be organised once a full application has been received and any peer reviews have been completed.
Inspections will normally be carried out by a team which includes:
- An HFEA Clinical Inspector
- An HFEA Scientific Inspector
- An HFEA General Inspector
Inspections normally include:
- General consideration of the licence application.
- A meeting and interviews with the senior members of staff at the centre.
- A full tour of the centre to inspect premises and equipment. The Inspection Team will, after the visit, prepare a report on the centre for the HFEA Licence Committee considering the application.
For research applications the composition of the Inspection Team and elements of the inspection may need to be changed to meet the needs of assessing the project.
The HFEA Regulation Department will assess and report on whether the application:
- Meets the statutory requirements of the Human Fertilisation & Embryology Act 1990
- Meets the requirements of the HFEA Code of Practice, Standard Conditions and the Authority's Directions
Applications together with the initial fee of £500 for a Treatment licence or £200 for a Storage Only licence should be sent to:
The Director of Regulation
Human Fertilisation & Embryology Authority
21 Bloomsbury Street
London
WC1B 3HF
Receipt of all applications will be acknowledged in writing. The application will be checked for any omissions, and the centre contacted if more documentation is required. Research applications and applications which include PGD and PGS will also need to be peer reviewed. The findings of any peer review will be discussed with the centre.
Decision by an HFEA Licence Committee
The HFEA has the power to grant licences for up to five years for treatment and storage of gametes and embryos. All licence applications, renewal inspection reports and interim inspection reports are evaluated by a HFEA Licence Committee.
The relevant HFEA Licence Committee will look at the centre's application and the report of the Inspection Team together with any other information which the Committee considers relevant. The Committee will consider the application in relation to the requirements of the HFE Act, Standard Conditions and the Authority's Directions and the provisions of the HFEA Code of Practice.
Once the Licence Committee has come to a decision regarding an application, it will write informing the Person Responsible and any Nominal Licensee of its decision.
The decision will be:
Granting of a licence
If the Committee decides to grant a licence, it will inform the Person Responsible and the Nominal Licensee and, on receipt of any additional fee which is due, it will issue the licence. Each licence is subject to certain statutory conditions which are set out in Sections 12 to15 of the HFE Act and to standard conditions which can be found in the Code of Practice 7th Edition and Chair's Letters.
Granting of a licence subject to specific conditions
If the Committee decides to grant a licence subject to additional conditions, it will inform the Person Responsible and the Nominal Licensee of these further conditions (in addition to those set out above).
Refusal of a licence
If the Committee proposes to refuse a licence, the applicant will be informed in writing (Section 19(1) of the HFE Act).
Licences will be issued only after the applicant and the Person Responsible have accepted the licence conditions in writing and paid any additional fee which is due. Centres have 28 days in which to notify us that they wish to make representations about a Licence Committee decision.
Appeals procedures
The HFE Act provides applicants with the right of appeal when a Licence Committee refuses to grant or vary a licence. Full details are set out in Sections 19, 20 and 21 of the HFE Act and the Human Fertilisation & Embryology Authority (Licence Committee and Appeals) Regulations 1991.
What happens once I am licensed?
After you are licensed an HFEA Inspection Team will inspect the quality of your service during the first year. During the inspection, you and your premises will be checked to make sure you continue to meet the Code of Practice requirements and that you continue to be suitable to provide assisted conception services.
The Inspector will write a report on your service and send you a copy, so that you can comment on its content before it is submitted to Licence Committee.
Where can I get further information?
You can obtain more information about the licensing of treatment and storage centres from:
Debra Bloor,
Head of Inspection
020 7291 8200
Freedom of Information