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New Regulations on importing gametes or embryos from outside the European Economic Area (EEA) and Gibraltar.

On 17th April 2018, we implemented a new EU Directive on the importation of sperm and eggs (“gametes”), and embryos, from outside of the European Economic Area (EEA) and Gibraltar. 

This EU Directive, which does not apply to imports from other EEA countries, was developed to ensure the quality and safety of tissues and cells being imported into the UK from a “third country supplier” – defined as any country that is outside of the EU, EEA and Gibraltar.

In relation to IVF, this means that imported gametes or embryos for a patient’s treatment must meet UK safety and quality standards around the testing, transportation and procurement of gametes.

In practice, this means that a clinic wishing to import from a third country supplier will need to apply to the HFEA for a certificate. As part of this process, the UK clinic will need to provide documents that guarantee the third country supplier meets UK quality and safety standards. If a clinic imports gametes or embryos without this certificate they will be non-compliant.

Because of the new procedure that is in place, there may be a delay in processing your application.  If all the correct information is supplied by your clinic, then the application should be processed within 2 – 3 months.

We apologise for any delay to your treatment during this transitional period, and are doing all we can to process applications as quickly as possible.

If you are unsure of what these new rules mean for your treatment, we suggest that you speak with your clinic first. If you have further questions after that you can contact us at: enquiriesteam@hfea.gov.uk.

 

Clinics approved to import from third country suppliers

Centre Tissues/Cells to be imported Third country supplier
Barts Health Centre for Reproductive Medicine Sperm California Cryobank
Wolfson Fertility Centre Sperm California Cryobank

 

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Publication date: 13 September 2018

Review date: 13 September 2020