The Human Fertilisation and Embryology (Amendment) Regulations 2018

Amendments to definitions in the 1990 Act

3.—(1) The 1990 Act is amended as follows.

(2) In section 1A (reference to Directives)(1)—

(a) in the definition of the “second Directive” at the end omit the “and”,

(b) in the definition of the “third Directive” at the end insert “, as amended by Commission Directive 2015/565/EU.”,

(c) after the definition of “the third Directive” insert—

“, and

“the fourth Directive” means Commission Directive 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.”

(3) In section 2 (other terms)—

(a) in subsection (1)—

(i) in the definition of “competent authority” for “and third” substitute “, third and fourth”, and

(ii) in the definition of “distribution” after “delivery” insert “to any person in or outside the United Kingdom for human application”,

(b) in subsection (2A) after “transporting gametes or embryos” insert “to any person in or outside the United Kingdom for human application”, and

(c) in subsection (2B) for “or third” substitute “, third or fourth”.

(4) After section 2A insert—

“2B    Meaning of “importing licensee”, “third country premises” etc

(1) This section applies for the purposes of this Act.

(2) “Importing licensee” means a person—

(a) to whom a licence applies, and

(b) who is authorised by directions under section 24(4) to import qualifying gametes or embryos into the United Kingdom from a third country.

(3) “Qualifying gametes or embryos” means gametes or embryos intended for human application.

(4) “Third country” means a country which is not an EEA state or Gibraltar.

(5) Premises are “third country premises” if—

(a) they are in a third country, and

(b) they are premises on, or from which, a third country supplier or a person providing services to a third country supplier procures, tests, processes, stores, distributes or exports qualifying gametes or embryos intended for import into the United Kingdom.

(6) “Third country supplier” means a person in a third country who has an agreement with an importing licensee for exporting qualifying gametes or embryos intended for import into the United Kingdom.”.

(1)

Inserted by S.I.2007/1522, regulation 5.