Chair's letter

09/06/2021 - CH(21)02

09 June 2021

This letter sets out a number of new requirements which come into force at the end of the transition period following the United Kingdom’s (UK) departure from the European Union (EU).

The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 provided for a six-month transitional period for the UK which began on 31 December 2020 at 11pm and will end on 30 June 2021. During this period certain statutory provisions pertaining to the import or export of gametes or embryos to or from the UK and a European Economic Area (EEA) state or Gibraltar do not apply. At the end of the transitional period, certain statutory provisions will take effect and further detail is set out below in relation to this.

From 11 pm on 30 June 2021, all countries outside the UK, including countries within the EU/EEA will become ‘third countries’ to Great Britain (GB; i.e. England, Scotland and Wales).

What does the end of the transitional period mean?

It means that if you are a clinic in GB and are importing gametes and embryos into GB from any other country, including from the EU/EEA, you must have an importing tissue establishment (ITE) import certificate in place. No such certification is required for exports from GB however, clinics must satisfy the requirements of General Direction 0006 pertaining to export, or apply for a Special Direction for export where those requirements cannot be met.

A new version of General Direction 0006 (GB) (version 9) setting out the revised requirements imposed on clinics in GB for imports and exports of gametes and embryos, will come into force on 30 June 2021. This can be found in Annex I of this letter.

There are two Schedules in version 9 of this Direction:

Note that these Schedules do not apply to the transfer of gametes or embryos by a licensed centre in Northern Ireland (NI) to one in GB, since the transfer is within the UK.

For imports into NI from a country in the EU/EEA, you will not require an ITE import certificate to be in place, as EU/EEA countries are not third countries to NI. For the purpose of importing third countries to NI include those outside of the EU/EEA (including GB), and imports to NI from such countries will require an ITE import certificate to be in place.

Centres in NI which are importing from centres in GB will be importing from a third country, as GB is a third country to NI. See Schedule 3 of General Direction 0006 (NI) version 1 for the requirements acting on such imports.

Annex II contains the revised Further Information Form which should accompany Special Direction applications from centres in GB.

Annex III provides a flowchart to help with identifying whether an ITE import certificate application is necessary based on the location of the UK licensed centre. As a reminder, the ITE import certificate application form is available in an electronic format on the Clinic Portal.

Licence conditions

Various Standard Licence Conditions (SLCs) have been amended to reflect changes in the legislation necessitated by EU Exit, for instance concerning traceability and the marking of medical devices. All clinics’ licences will be varied and clinics should have received their new licences containing the varied SLCs by email; these will come into effect on 1 July 2021. If we have not received acceptance of the new licence yet, we will be in touch with clinics separately. The amended SLCs can be found in Annex IV (GB) and Annex V (NI).

Annexes

Please see the following annexes for the revised General Directions and other information.

Please take the time necessary to ensure you and your staff are familiar with the requirements. Your inspector will provide support if needed.

Yours sincerely,

Julia Chain's signature

Chair, Human Fertilisation and Embryology Authority