22 September 2011
Update to General Directions 0008
I am writing to inform you that we have amended General Directions 0008, which sets out the information centres should submit to the Authority as part of the licensing process. The Directions come into force on 1 October 2011.
Applications for a new licence must be supported by a range of information explaining how the applicant will meet the regulatory requirements set out in the Human Fertilisation and Embryology Act 1990 (as amended), HFEA Directions and the Code of Practice.
However, we have substantially reduced the information which a Person Responsible of an existing licensed centre must submit when applying to renew a licence.
Procedure for authorising the processes used to carry out licensed activities
The Direction also introduces a new procedure for authorising processes used in carrying out licensed activities.
We have recently issued new licences to all centres, which come into effect on 1 October 2011. On the revised licences, the list of ‘licensable activities’ only includes activities directly referred to in the Act (for example, the creation of embryos; the storage of gametes). Licences no longer list processes used to carry out licensable activities (for example, IVF or assisted hatching).
As a consequence of this change, you will no longer need to apply for a licence variation to carry out a process for the first time. Instead, you will only need to apply to carry out a novel process, that is, one which has not previously been authorised by the HFEA for use in any UK centre. Processes which have been approved will be listed on the HFEA website and can be carried out by any licensed centre, provided that your licence authorises the associated licensed activity and you notify us of your intention to use the process.
If you wish to carry out a process which is not on the list or has only been authorised for a specific, named, centre, then an application to the HFEA must be submitted using the application form available on the HFEA portal with the following information:
- What the novel process is;
- Which licensed activity the novel process will be used for;
- Evidence that the new process is safe;
- Evidence that the new process is effective;
- Copies of the information provided to patients relating to the new activity;
- Evidence that the process and, where applicable, the equipment used to carry out the new process have been validated; and
- A schedule of the quality indicators, and reporting arrangements, established for this process.
If the Authority decides to authorise this new process, it will be added to the list of authorised processes on the HFEA website. A decision tree for you to use when considering carrying out a licensed activity using a new process, for the first time, is attached at Annex A to this letter.
Furthermore, you must inform us through the HFEA portal of all the processes you are currently using to carry out licensed activities. This facility will be available by the end of October 2011.
The revised General Directions 0008 will be available on the HFEA website from 1 October. If you have questions about the new directions or the procedure for authorising new processes, please contact your inspector in the first instance.
Lisa Jardine CBE
- Annex A: Decision tree for centres to use when considering carrying out a licensed activity using a new process for the first time
- General Directions 0008
Page last updated: 17 August 2012