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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.

Due to the volume of applications the HFEA is currently receiving since the rule change, we expect a maximum delay of 2-3 months from the day the application form is submitted to the HFEA to when a certificate can be provided to the UK clinic. As this volume decreases, the delay will reduce.

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.

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Publication date: 23 May 2018

Review date: 23 May 2020