15 December 2020
This letter sets out changes we have made as a result of the United Kingdom (UK) leaving the European Union (EU) on 31 January 2020, and the Implementation Period (IP) ending at 11pm on 31 December 2020.
The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 have been approved by Parliament. These Regulations are the means by which the Northern Ireland Protocol (NIP) is implemented in so far as it relates to reproductive tissues and cells (gametes and embryos). Under the NIP, Northern Ireland (NI) will continue to enforce EU customs rules and follow its rules on product standards. The rest of the UK will stop following those rules, meaning some new processes on movements between Great Britain (GB, i.e. England, Scotland and Wales) and NI will be introduced.
The Human Fertilisation and Embryology Act 1990 (HF&E Act) will continue to apply UK wide, but with some amendment resulting in certain provisions applying in relation to NI only and, in some instances, to GB only. As a consequence, certain changes have been made to General Direction 0006, 0009 and 0013, as well as to the Special Direction decision tree, relevant application forms and templates. Any necessary changes will also be made to the Code of Practice with the next update (October 2021), including a new dedicated guidance note specific to regulation in NI.
The new versions of General Directions can be found in the Annexes to this letter, as well as further guidance. They are also on Clinic Portal, although they will only come into force on 31 December 2020 at 11pm.
Some Licence Conditions will also need to be amended to reflect changes in the legislation necessitated by EU Exit, for instance concerning traceability and the marking of medical devices. In line with advice, the HFEA will be implementing changes to Standard Licence Conditions in 2021. We will be communicating with you regarding the detail of the changes and how they will be implemented in Spring 2021.
Details of the changes and when they are to come into force are outlined below.
Changes to General Directions
From 31 December 2020, HFEA licensed clinics in Great Britain (i.e. England, Scotland and Wales) are required to comply with:
- General Direction 0006(GB) (version 8) on imports and exports of gametes and embryos – in force from 11 pm 31 December 2020 to 30 June 2021;
- General Direction 0009(GB) (version 2) on keeping gametes and embryos in the course of carriage between premises – in force from 11 pm 31 December 2020;
- General Direction 0013(GB) (version 3) on traceability – in force from 11 pm 31 December 2020
From 31 December 2020, HFEA licensed clinics in Northern Ireland are required to comply with:
- new General Direction 0006(NI) (version 1) on imports and exports of gametes and embryos;
- new General Direction 0009(NI) (version 1) on keeping gametes and embryos in the course of carriage between premises;
- new General Direction 0013(NI) (version 1) on traceability
Transitional period
The EU Exit Regulations 2020 provide for a six-month transitional period for GB which begins on 31 December 2020 at 11pm and ends on 30 June 2021.
This applies to imports and exports of gametes or embryos to or from a country in the European Economic Area (EEA) or Gibraltar.
GD0006(GB) (version 8) will be in force for the transitional period i.e. from 31 December 2020 until 30 June 2021, during which time certain import and export requirements will not apply. At the end of the six-month transition period, a GD0006(GB) (version 9) will be introduced for clinics in GB, which will outline the new requirements in relation to the import and export of gametes and embryos. This will reflect countries within the EEA and Gibraltar becoming ‘third countries’ to the UK.Annexes III to V provide further information including the revised application form for an Importing Tissue Establishment (ITE) certificate which will be required to authorise an import. This application form will be available in an electronic format on the Clinic Portal. The version attached here is for reference only.
Changes to Special Direction application forms
Amendments have been made to Special Direction documents, which clinics must use to apply to the HFEA for Special Directions for an import or export of gametes or embryos where the requirements of the relevant version of General Directions 0006 cannot be met. A new Special Directions application form will be available on the password-protected side of Clinic Portal, as well as amended ‘Further Information Forms’. These forms allow a clinic to explain why, despite not meeting the requirements of GD0006, a Special Direction permitting the import/export should be made and sets out the information that should be provided. These Further Information Forms are specific to whether the application for Special Direction is from a centre in GB or in NI, and if from GB, whether the import or export will be before or after 30 June 2021.
Annexes
Please see the following annexes for the revised General Directions and other guidance.
- Annex I: Summary of General Directions for Great Britain (i.e. England, Scotland and Wales)
- General Direction 0006(GB) (Version 8)
- General Direction 0009(GB) (Version 2)
- General Direction 0013(GB) (Version 3)
- Annex II: Summary of General Directions for Northern Ireland
- General Direction 0006(NI) (Version 1)
- General Direction 0009(NI) (Version 1)
- General Direction 0013(NI) (Version 1)
- Annex III: Guidance on importing and exporting
- Annex IV: Application to authorise an importing tissue establishment (draft)
- Annex V: Flowchart for identifying if an ‘Importing tissue establishment (ITE) import certification application’ is necessary
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
Chair, Human Fertilisation and Embryology Authority.