EU Tissues and Cells Directive (EUTCD)

 

EUTCD Licence Application

Who needs to complete this application and self-assessment document?

  • Centres providing fertility treatments and procedures that do not currently require a licence under the HF & E Act 1990.
  • Currently-licensed centres that carry out any of the services listed below.

You will only be able to provide the services listed below after 7 April 2007 if you hold a HFEA licence permitting you to do so.
 
Treatments and fertility services which require a licence under the EUTD and HF & E Act 1990; 

  • Gamete Intra Fallopian Transfer (GIFT), using patients own gametes
  • Artificial insemination using patients own gametes, involving intrauterine insemination (IUI), intracervical insemination (ICI) and other insemination methods where processing steps are applied.
  • Surgical procedures to collect sperm and eggs
  • Donor Insemination, involving the use of fresh donor sperm
  • Preparation and testing of sperm for human application, including sperm washing, sperm sorting and viability tests such as the Hypo-osmotic swelling (HOS) test
  • Non Medical Fertility Services*
  • Treatments currently licensed by the HFEA

* Non Medical Fertility Services include internet-based donor sperm supply companies not courier services

To make an application for an HFEA licence please complete the relevant sections of this form and return it along with all necessary supporting information (see checklist) and application fee to:

The Regulation Department
Human Fertilisation and Embryology Authority,
21 Bloomsbury Street
London
WC1B 3HF

 

Initial Treatment Licence Application and Self Assessment Document (338 Kb)

 

The European Union (EU) Tissues and Cells Directive was adopted by the Council of Ministers on 2 March 2004 and published in the Official Journal of the European Union on 7 April 2004. Member States are obliged to comply with its provisions from 7 April 2006.

A copy of the Directive can be downloaded below. Additional information about the Directive will be posted here as it becomes available.

EU Tissues and Cells Directive (246.5 Kb)

 

Technical Annexes

Both the first and second technical Directives have now been finalised.

The European Commission adopted the first technical Directive, covering donation, procurement and testing, in February 2006.

First Technical Directive (85 Kb)

The European Commission adopted the second technical Directive covering processing, preservation, storage and distribution in October 2006. 

Second Technical Directive (165 Kb)

> Read  the evidence and reasoning behind the HFEA's current policy position on the level of air quality required under the EU Tissues and Cells Directive

 

Newsletters

> Read our latest newsletter on the EU Tissues and Cells Directive.

 

Consultation on application fees for licensing under the Directive

The HFEA are currently consulting on application fees for licensing under the European Tissues and Cells Directive. All previously unlicensed services will have to apply for a licence from the HFEA. The consultation document below sets out a proposal for the application fee, which has been set to cover:

  • assessment process for licence applications from previously unlicensed services under the EUTCD
  • provision of support to these services prior to licensing, including three regional workshops
  • issuing of licences under the EUTD to ensure all relevant services may continue to practice legally from 7 April 2007

Comments on the proposal should be submitted to eutdfees@hfea.gov.uk by 13 October 2006.

Consultation on application fees for licensing under the EU Tissues and Cells Directive (36 Kb)

 

HFEA Assisted Conception Standards

The HFEA, in collaboration with the professional bodies of the assisted conception sector, have drafted a set of Standards for Assisted Conception Centres which include the requirements of the the EU Tissues and Cells Directive.

 

HFEA Guidance

The HFEA recently clarified its guidance in relation to third parties and air quality. These documents supersede any previously issued guidance.

Third Party Guidance Note (54 Kb)

Air Quality Guidance Note (27 Kb)

 
Information for IUI and GIFT centres

The Department of Health recently clarified their implementation plans for the European Tissue Directive, specifically around the implementation dates.
 
The information is particularly relevant to IUI and GIFT establishments and we have produced further information to explain what the implications are for these services.
 
The explanatory paper also breaks the Directive down to single out which aspects of the text apply to IUI and GIFT establishments, and how the requirements will impact them.

Letter to centres for the Department of Heath (23 Kb)
EU Tissues and Cells Directive - Implementation dates

Information for IUI and GIFT establishments (29 Kb)
November 2005

Explanatory Paper for IUI and GIFT Establishments (60 Kb)

 

Public Consultation

As competent authority for reproductive cells under the EU Tissue and Cells Directive (EUTCD), the HFEA's regulatory remit is being extended to include the licensing of services involving fresh gametes such as intra uterine insemination (IUI) and gamete intra-fallopian transfer (GIFT). Under the EUTCD, additional requirements are being introduced for all centres, including implementation of a quality management system.

There is no additional funding available for the extension of the HFEA's role, and the cost of inspection and licensing under the EUTCD must be covered from fees collected from those centres requiring a licence.

The scope of this consultation covers annual and licence renewal fees which will be chargeable for all centres coming into the regulatory framework from April 2007.

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Last updated: 13 August 2007