The post EU-Exit Implementation Period ends at 11pm on the 31 December 2020, and the Transition Period ends at 11pm on 30 June 2021 at which point regulatory changes will be implemented.
New and amended versions of three General Directions came into force at 11pm on 31 December 2020 and a new version of General Direction 0006 for Great Britain (GB i.e. England, Scotland and Wales) will come into force on 30 June 2021. These are available on the Clinic Portal here.
From 31 December 2020, HFEA licensed clinics in Northern Ireland (NI) 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
From 31 December 2020, HFEA licensed clinics in Great Britain (GB i.e. England, Scotland and Wales) are required to comply with:
- 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 30 June 2021, HFEA licensed clinics in GB are required to comply with:
These new and revised versions of General Directions supersede associated guidance in the Code of Practice, which will be considered inactive. The Code of Practice will be updated in October 2021 to reflect the revised General Directions.
Please see the following Chairs Letters which outline these changes in greater detail and provides further guidance:
15/12/2020 CH(20)02: Regulation changes for the end of the Implementation Period
09/06/2021 CH(21)02: Regulation changes for the end of the Transition Period
Changes to import requirements
From 30 June 2021, licensed centres in GB:
- Will import and export under GD0006(GB) version 9, or under the Special Direction scheme;
- Will need pre-approval through their HFEA issued ITE import certificates, for gamete and embryo imports from suppliers in third countries. After 30 June 2021, all countries outside of the UK, including those in the EEA, are considered third countries; and
- Will be able to import and export freely from/to NI, though a centre in NI receiving gametes or embryos from GB will need approval via their ITE import certificate from 31 December 2020 onwards.
From 31 December 2020, licensed centres in Northern Ireland:
- Will import and export under a new GD0006(NI) version 1, or under the Special Direction scheme; and
- Will need pre-approval through their ITE import certificates, for gamete and embryo imports from countries outside the EEA, including for movements from GB to NI from 31 December onwards.
Please use this flowchart to identify whether an ITE import certificate application is required.
The ITE import certificate application form is held in the licensing applications function in the centre-restricted area of the Clinic Portal. Please see this page for guidance on how to complete the import application form and for Frequently Asked Questions.
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. More information can be found on this page on the Clinic Portal.
The Special Direction application form is available as an electronic format in the centre-restricted area of the Clinic Portal.
The Special Direction application, must be accompanied by a completed Further Information Form, the version used being specific to the version of General Direction 0006 acting on the planned transport:
Further Information Form for GD0006(GB) version 9: For centres in Great Britain (i.e. England, Scotland or Wales) transporting gametes and/or embryos after 30 June 2021;
Further Information Form for GD0006(NI) version 1: For centres in Northern Ireland transporting gametes and/or embryos after 31 December 2020.
Traceability of reproductive cells
After 31 December 2020 centres in Northern Ireland must continue to use the Single European Code (SEC) in the normal manner. Centres in England, Scotland and Wales can stop using the SEC if they wish to, though they must continue to comply with Licence Condition requirements relevant to traceability and the labelling of vessels containing gametes and embryos.
Regulation in Northern Ireland
From 11 pm on 31 December 2020, HFEA licensed centres in Northern Ireland (NI) will, under the Northern Ireland Protocol, remain under an EU regulatory structure as well as the HF&E Act 1990 (as amended). The HFEA will be the ‘competent authority’ in Northern Ireland (CA-NI) for fertility sector regulation and will continue to report to the EU regarding the fertility sector in NI.
Licensed centres in England, Scotland and Wales (i.e. in Great Britain) will be regulated by the HFEA against the HF&E Act 1990 (as amended). HFEA activities in Great Britain will not be considered by the EU as being those of a ‘competent authority’. The HFEA will also no longer report to the EU on the activities of licensed centres in England, Scotland and Wales.
The CA-NI function of the HFEA will be delivered by a sub-group of HFEA staff with designated roles providing to the CA-NI function. Those staff will also have roles in the HFEA regulation of the fertility sector in Great Britain.
The regulatory schemes applied in Great Britain and NI will initially be virtually the same, except in a few areas (gametes and embryo movements, use of the SEC, medical device conformity) resulting from the effects of the Northern Ireland Protocol. Divergence in the schemes may occur in future but since guarding the quality and safety of gametes and embryos used in patient treatment is at the centre of both schemes, the rate of divergence is likely to be very slow. The sub-group of staff forming the CA-NI function will be well versed in any differences between the regulatory schemes.
Please use the following links to prepare for EU exit.
Authority papers
November 2020 - EU exit: HFEA preparations for the end of the transition period
Clinic Focus Special Editions
June 2021 - EU Exit: Regulatory changes for the end of the Transition Period
December 2020 - EU Exit: Regulatory changes for the end of the Implementation Period
April 2019 - EU exit extension special edition
April 2019 - Special edition
March 2019 - Special edition
February 2019 - Special edition
Letters
30 March 2021 – Letter from Steve Oldfield, Chief Commercial Officer, regarding continuity of medical supplies
21 December 2020 – Letter from Professor Keith Willett, National Director for Emergency Planning and Incident Response, regarding the National Supply Disruption Response system (NSDR)
17 November 2020 - Letter from Steve Oldfield, Chief Commercial Officer, regarding continuity of supply and the end of the Transition Period
3 August 2020 - Letter from Steve Oldfield, Chief Commercial Officer, regarding the end of the Transition Period
31 January 2020 - Letter from Steve Oldfield, Chief Commercial Officer, regarding continuity of supply
5 November 2019 - Letter from Steve Oldfield, Chief Commercial Officer, regarding recommended next steps relating to continuity of supply
29 October 2019 - Letter from Steve Oldfield, Chief Commercial Officer, regarding extension of the Article 50 period to 31 January 2020
23 October 2019 - Letter from Steve Oldfield, Chief Commercial Officer, regarding EU Exit contingency planning: National Supply Disruption Response system
8 October 2019 - Letter from Steve Oldfield, Chief Commercial Officer, regarding the Government’s contingency planning to get ready for EU Exit on 31 October 2019
24 July 2019 - Continuity of supply of medicines and medical products
24 July 2019 - 'No deal' contingency planning assumptions for continuity of supply of medicines and medical products
23 May 2019 - Letter on extension of Article 50
3 April 2019 - Letter from NHS England regarding the National Supply Disruption Response system
Guidance
23 March 2021 - Webinar: Trader readiness for 1 October 2021 import controls
23 March 2021 - Webinar: Update on importing medical goods containing products of animal origin from EU into Great Britain
11 February 2021 - Communication from DHSC on couriers and duty payments
18 January 2021 - Customs helpline and helpdesk support
05 January 2021 - Trader readiness for medical suppliers
05 January 2021 - Communication from the HFEA: Customs requirements for importing and exporting blood, organs, tissues and cells between the UK and the EU from 1 January 2021
15 December 2020 - GB-NI trader readiness for the end of the transition period webinar
15 December 2020 - Trader Support Service (TSS) webinar Q&A
8 December 2020 - Trader Support Service (TSS) latest updates webinar
23 November 2020 - Government Secured Freight Capacity Haulier and Supplier Ticketing Guide
11 November 2020 - Email from the HFEA about the end of the transition period
26 October 2020 - Overview of HDSC Border Operating Model – DHSC Webinar
26 October 2020 - DHSC Exports Webinar Presentation
21 October 2020 - Registering for the Cross Government Freight-Capacity Solutions Webinar slides
13 October 2020 - Government Secured Freight Capacity Supplier and Haulier Information Guide
13 October 2020 - Freight Capacity Press Notice
8 October 2020 - Border Operating Model Action Checklist
5 October 2020 - DHSC Controlled Good Presentation
29 September 2020 - Preparations for the end of the Transition Period
29 September 2020 - Reasonable Worst Case Scenario (RWCS) for our borders
16 September 2020 - DHSC Standard Imports Presentation
Updated guidance on Medical Devices and Medicines
23 October 2020 -
- Regulating medical devices from 1 January 2021
- Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland from 1 January 2021
- Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
- Acting as an Responsible Person from 1 January 2021
- Supplying medicines to Northern Ireland from 1 January 2021
- Importing a human medicine
- NIBSC guidance on batch manufacturing
- Reporting requirements for medicines shortages and discontinuations
Guidance on Trade Readiness
16 September 2020 –
- The Border Operating Model, published on 13th July 2020
- Guidance on the import control system
- Guidance relating to EORI numbers
- Guidance on using simplified declarations for imports
- List of customs agents (Please note these are not endorsed in any way or favoured by HMRC.)
- Letter to suppliers trading from or via the EU, published 3rd August 2020
- List of controlled goods
- Details on import and export licences for controlled goods
- Guidance on importing human medicines
Updated Border Operating Model
8 October 2020 –