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19 June 1991

To all Directors of Centres

Dear Director

LICENSING CENTRES FROM 1 AUGUST 1991

From 1 August, it will be necessary to have a licence issued by the HFEA to carry on any of the following activities (referred to as licensable activities):

- bringing about the creation of an embryo;
- keeping or using an embryo;
- storing any gametes or embryos;
- using donated sperm or eggs in the course of providing treatment services for any woman; or
- mixing gametes with the live gametes of any animal (the "hamster test").

You will find enclosed application forms for treatment and research licences. If your centre is carrying out, or proposes to carry out, any of these activities, it will be necessary to complete and return the relevant forms, accompanied by an initial licence fee, to the Authority by 1 August. Centres providing only storage should complete a treatment licence application.

Guidance on the completion of application forms is included in the enclosed document "Licence Applications - a guide for centres". We will notify you shortly of the initial and additional fees you will need to pay before a licence is granted. The Human Fertilisation and Embryology Act says that the amount of fees must be approved by the Secretary of State for Health and the Treasury and our proposals for a fees structure are currently under consideration by the Department of Health and the Treasury. The structure which is agreed will need to reflect the level of income which the HFEA is required to generate.

Centres must return their applications by 1 August to benefit from the transitional licensing arrangements outlined below. Failure to return its application forms by 1 August will result in a centre having to suspend all licensable activities from that date until the Authority actually issues the centre with a licence. You might therefore consider sending your application by recorded delivery to establish proof of posting in case it goes astray for any reason. We will acknowledge receipt of your application as soon as we receive it. Please let us know if you do not receive an acknowledgement within seven days of sending your application.

Transitional licensing arrangements

Clearly the Authority will not be able to consider all licence applications immediately. There will be a transitional period which will last for one year and all initial applications will be determined within that period. Centres will be allowed to continue operating from 1 August as if they were licensed until their applications have been determined. However, the transitional arrangements for treatment and storage centres will be different from research centres.

The transitional provision will allow all treatment centres operating before 1 August to carry on with their current activities, though they should not begin any new activities which require a licence without first obtaining one. Research centres which hold licenses from the Interim Licensing Authority (ILA) will also be able to carry on their licensed research projects during the transitional period. However, any research project which has not been licensed by the ILA will have to be suspended until an HFEA licence is issued. No new licensable projects can be started after 1 August until an HFEA licence is obtained.

Further details of the transitional arrangements, including provisions about the use of gametes and embryos collected and stored before 1 August, will be issued as soon as possible.
 

Manual for centres

To assist centres in understanding the new licensing system, the Authority has produced a manual to contain information about the following:

- licensing procedures
- the Code of Practice
- information requirements
- transitional arrangements
- directions to centres on specific matters
- other matters.

A copy of the manual containing the first section on licensing procedures (except Annex 5 on checklists, which will follow) is enclosed. Other sections will be issued for inclusion in the manual as soon as they are available. In this way, centres will be able to build up a comprehensive package of Authority documents. By using a ring-binder for these documents, you will be able to add to or amend any part of the package with ease and costs will be kept to a minimum. We hope that you will find the manual useful and easy to follow.

We look forward to receiving your licence applications. Please contact Hugh Whittall or David Howell on 071 600 3272 if you have any enquiries about this letter or about any licensing matters.

Yours faithfully

 

COLIN CAMPBELL

Page last updated: 15 August 2012

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