Human Fertilisation and Embryology Act 1990

[F1 [F2 11C (1) The modifications to the third Directive are as follows. U.K.

(2) Annex 1 is to be read as if—

(a) in paragraph A.1—

(i) for “responsible person” there were substituted “ person responsible ”;

(ii) for “as provided in Article 17 of Directive 2004/23/EC” there were substituted “ in accordance with the requirements of sections 16 and 17 of the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(c) in paragraph C.6, for the words from “requirements of Council” to the end there were substituted “ requirements of the Medical Devices Regulations 2002 ”;

(d) in paragraph D.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(e) in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(f) in paragraph E.8, the reference to the competent authority were a reference to the Authority.

(3) Annex 2 is to be read as if—

(a) in the first paragraph, the reference to the competent authority were a reference to the Authority;

(b) in paragraph A, for the words from “the tissues and cells must” to the end there were substituted “ tissue establishment procedures must ensure that the licence conditions in paragraph 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 are met ”;

(c) in paragraph B.3, for the words from “the standards” to the end there were substituted “ the requirements of paragraph 10 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”;

(d) in paragraph B.8, the second sentence were omitted;

(e) in paragraph C.2, for “laid down in this Directive” there were substituted “ of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”;

(f) in paragraphs C.4 and C.5, any reference to the responsible person as defined or specified in Article 17 of Directive 2004/23/EC were a reference to the person responsible in accordance with section 17 of this Act;

(g) in paragraph D.5, the reference to the competent authority were a reference to the Authority;

(h) in paragraph E.2(h), for “as set out in Articles 5 to 6” there were substituted “ in accordance with paragraph 3 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”.]]

Textual Amendments

F1 Sch. 3A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 30

F2 Sch. 3A paras. 11A-11C and cross-heading inserted (31.12.2020) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/482), regs. 1, 2(17)(c) (with reg. 4) (as amended by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(c)); 2020 c. 1, Sch. 5 para. 1(1)