Application form V1A (140 Kb)
Change of Person Responsible or Change of Nominal Licensee
Application form V1B (111 Kb)
Notification to HFEA of changes of staff associated with the licence
Application form V1C (104 Kb)
Change of treatments
Application form V1E (70 Kb)
Change of a condition of the licence
Change of premises forms
The change of premises forms are currently under review. If your centre is considering a change of premises, or a change in the layout of your existing premises, you will need to contact your centre´s inspector for advice on the procedure to follow.
You must apply to vary your licence where there is:
You may apply for:
A change in a condition of your licence
The Human Fertilisation and Embryology Act 1990 (as amended) provides for Licence Committees to vary a licence on an application by the Personal Responsible or the Nominal Licensee. Section 17 (4).
The licence can only be varied in so far as it relates to the activities authorised by the licence, the manner in which they are conducted or the conditions of the licence or to extend or restrict the premises to which the licence relates (Section 17(6)) The Licence Committee may on an application by the Nominal Licensee, vary the licence so as to designate another suitable individual in place of the Person Responsible (with the consent of the other individual). (Section 17 (5)).
If your centre is considering a change of premises, or a change in the layout of your existing premises, you will need to contact your centre´s inspector for advice on the procedure to follow.
Where there is a change of staff to whom the licence applies, the PR must notify the HFEA using form V1B.
The application to change the Person Responsible (PR) must be made by the Nominal Licensee (NL) using form V1A. The current PR must complete a section of the application form giving notification of their resignation and the proposed new PR must complete a section of the application form giving consent for the application to be made on their behalf.
The new PR will be required to complete the Person Responsible self-assessment with the results forwarded to the designated Inspector for the centre. An interview may be arranged subject to the level of competence demonstrated by the applicant. It is the responsibility of the NL to ensure that the recruitment process for the post of PR covers the requirements of the HFE Act 1990 and the successful candidate is suitable to be put forward for consideration to be licensed by the Licence Committee.
The Nominal Licensee will be the licence-holder where it is a Health Authority, Health Board, Health and Social Services Board, NHS trust or other body and the person responsible is in charge of the premises in which the activity which is the subject of the licence is carried on.
Licences will be granted either to an individual who will him/herself control the premises where the activity to be licensed is to be carried on (who will himself be "the person responsible"); or to another person or body which manages the premises on which the activity is to be carried on.
The other body which manages the premises might be a Health Authority or Special Health Authority in England and Wales, a Health Board in Scotland or a Health and Social Services Board in Northern Ireland or a NHS Trust or a voluntary organisation or company. Where application is made by such another person or body, an individual must be designated as "the person responsible" and his/her consent to the application must be obtained by that other person or body.
Applications may be made (form V1C) to add or remove licensable treatments. Supporting documentation, including information for patients, must be submitted along with reasons for the changes.
You may apply to vary your licence to remove or change a condition on your licence (form V1E). You should give clear reasons for making your application.
The Licence Committee will make a decision about your application by granting or refusing it. We cannot guarantee that your application will go to any particular Licence Committee but it will be presented at the earliest opportunity providing your application is complete with all the relevant information.
The Inspector may need to visit the centre if substantial changes are being proposed before finalising the report on your application to be considered by the Licence Committee. We do not set specific time scales but you should allow sufficient time for the application to go though all the stages. You should discuss the time scales with your Inspector when you plan to make an application and notify him/her of any key dates so these may be taken into account.
The HFE Act 1990 provides applicants with the right to make representations 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 1990.
The Person Responsible is required to notify the HFEA of changes in staff so that we can maintain a record of who is covered by the licence. Please refer to Chair's Letter CH(01)08.
Form V1B should be completed and returned to the HFEA as soon as possible after a new staff member commences or leaves employment.
The HFE Act 1990 places a clear duty on the Person Responsible to ensure the integrity of the character and qualifications of any staff working within a licensed centre. Section 17(l)(a) of the Act states:
"that the other persons to whom the licence applies are of such character, and are so qualified by training and experience, as to be suitable persons to participate in the activities authorised by the licence".
This requirement applies equally to temporary or casual staff. Where staff are to be employed under the direction of the Person Responsible or a designated staff member, the Authority strongly advises the centre to obtain completion of a personal declaration to indicate that the person fully understands the confidentiality requirements of the HFE Act, and is aware of the requirement of compliance with the HFEA's Code of Practice. A sample confidential declaration is included in the pack.
Further information on any of these changes may be obtained from the HFEA website or by contacting your Inspector.