Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

Mandatory requirements (cont)
T51
The centre must ensure that the laboratory tests required by licence condition T50 meet the following
requirements, namely:
a. the test must be carried out by a qualified laboratory, which has suitable accreditation (for
example by CPA (UK) Ltd or another body accrediting to an equivalent standard), using
CE marked testing kits where appropriate. The type of test used must be validated for the
purpose in accordance with current scientific knowledge, and
b. blood samples must be obtained at the time of donation.
T75
Centres must ensure that all storage processes are carried out under controlled conditions.
T76 Gametes of a person must be placed in storage only if –
a. received from that person,
b. acquired in circumstances in which by virtue of paragraph 9 and 10 of Schedule 3 to the
Human Fertilisation and Embryology Act 1990 (as amended) that person’s consent to the
storage is not required, or
c. acquired from a person to whom a licence or third party agreement applies.
T77 Embryos taken from a woman must be placed in storage only if –
a. received from that woman, or
b. acquired from a person to whom a licence or third party agreement applies.
T78
T79
T80
T81
T82
Embryos which have been created in vitro otherwise than in pursuance of this licence must be placed
in storage only if acquired from a person to whom a licence or third party agreement applies.
No gametes or embryos must be kept in storage for longer than the statutory storage period and,
if stored at the end of the period, must be allowed to perish.
The statutory storage period in respect of gametes is such period not exceeding ten years as the licence
may specify.
The statutory storage period in respect of embryos is such period not exceeding ten years as the licence
may specify.
Regulations may provide that licence conditions T80 and T81 must have effect as if for ten years there
were substituted –
a. such shorter period, or
b. in such circumstances as may be specified in the relevant Regulations, such longer period, as
may be specified in the relevant Regulations.
T83
T84
Gametes or embryos which are or have been stored must not be supplied to a person otherwise than
in the course of providing treatment services, unless that person is a person to whom a licence applies.
With respect to treatment involving storage of eggs and any other subsequent activities the following
licence conditions apply:
a. That before a woman gives consent to the storage and/or use of cryopreserved eggs in
treatment services she must be given an oral explanation supported by relevant written
material explaining,
(a) all risks associated with the cryopreservation and thawing of eggs, and
(b) that counselling is available.
b. That the centre must not mix, in the same treatment cycle:
(a) fresh eggs with eggs that have been cryopreserved
Human Fertilisation and Embryology Authority
Guidance note | 17. Storage of gametes and embryos
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