Miscellaneous and General

Powers to make regulations in relation to standards of quality and safety
42A
1
The Secretary of State may by regulations make provision specifying requirements to be met for the purposes of ensuring traceability.
2
The Secretary of State may by regulations make provision in relation to the notification of serious adverse events and serious adverse reactions (whether to the Authority or such other person as may be specified in the regulations).
3
The Secretary of State may by regulations make provision specifying requirements to be met for the purposes of verifying that standards of quality and safety equivalent to those required pursuant to this Act apply in relation to imports by tissue establishments of gametes and embryos from third countries.
4
The Secretary of State may by regulations make provision specifying technical requirements in relation to the following—
a
the licensing or authorisation of tissue establishments;
b
the procurement of gametes or embryos;
c
selection criteria for donors of gametes and embryos;
d
laboratory tests required for donors;
e
procedures for the reception of gametes and embryos at the tissue establishment;
f
the gamete and embryo preparation process;
g
gamete and embryo processing, storage and distribution.
5
The provision that may be made in regulations under this section includes provision amending this Act and may modify, or further modify, the provisions of the second, third and fourth Directives as they apply by virtue of this Act.
6
The Secretary of State may only make regulations under this section in relation to Great Britain.
S. 42A inserted (31.12.2020) by S.I. 2019/482, regs. 1, 2(14) (with reg. 4) (as amended by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 15); 2020 c. 1, Sch. 5 para. 1(1)