CE(10)02
29 March 2010
Dear Colleague,
New Compliance cycle starting in April 2010
Over the past 18 months we have been consulting you on how we carry out our regulatory responsibilities. We’ve listened to what you had to say and made fundamental changes to our processes. These have direct implications for all centres.
I am therefore writing to remind you that the new Compliance cycle that we have been developing comes into operation fully from the beginning of April 2010.
Centres that are able to clearly demonstrate compliance to a Licence Committee can expect to receive a four year licence and to be inspected once every two years.
More frequent inspections may be made, of centres where we have concerns about their compliance, particularly if we consider the safety of patients, embryos and gametes are at risk. In these circumstances, shorter licences may be issued by a Licence Committee.
The focus of inspections will be on themes agreed by the Authority and will also in part be determined by the responses centres give to the self-assessment questionnaire (SAQ) that should by now have been completed. Persons Responsible must ensure that this SAQ is updated prior to the next inspection, in accordance with paragraphs 28 and 29 of General Direction 0008. If you have not yet completed your initial SAQ, please could I ask you to do so without delay.
Our new inspection reports enable us to highlight good practice and any improvements that have been made following the inspection, so that Licence Committees and the Executive Licensing Panel have the most up to date information before them when making their decisions.
Licence Committees and the Executive Licensing Panel have begun to follow newly defined decision trees. These can be found at http://www.hfea.gov.uk/1128.html. They spell out in an algorithm the successive stages that are followed in considering an application. They will ensure a methodical and consistent approach. I would suggest that, when you can, you find the time to look at these well in advance of any application you intend to make.
All of our forms are now on the clinic portal on our website and this should be used for submitting new and renewal licence applications. Please note that General Direction 0008 also sets out the documentation that is required when making a licence application. We will not submit your application to the Licence Committee/Executive Licensing Panel unless it is accompanied by the full range of documents described in this General Direction and the fee payable.
As you know, we give you the opportunity to comment on the inspection report itself and through our post-inspection questionnaire. We are already receiving positive comments on the new approach to regulation and would very much value your views on how the Compliance cycle is working for you.
Finally, there is the matter of the time taken to process applications. One of our aims was to streamline this and we have begun monitoring our performance. Attached to this letter, as an Annex, is a notional timeline that spells out all the different stages of an application, together with an indication of the length of time each stage could take. This timeline will be available on our website so that PRs can refer to it when thinking about their own applications.
Yours sincerely
Alan Doran CB
Chief Executive
Page last updated: 24 August 2012