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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a), (b), (c), (f) and (g)) arising from the withdrawal of the United Kingdom from the European Union.

These Regulations make amendments to legislation concerning gametes and embryos intended for use in human application. In particular, they amend legislation relating to technical requirements for the storage, procurement, testing, processing or distribution of gametes and embryos, and the import of gametes and embryos into, and their export from, the United Kingdom. Part 2 amends primary legislation, Part 3 amends subordinate legislation, and Part 4 makes transitional provision.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the private or voluntary sector is foreseen.