Human Fertilisation and Embryology Act 1990 (c. 37)

SCHEDULES

[F1 SCHEDULE 3A U.K. SUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION

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 Modifications to the first, second and third Directives U.K.

Textual Amendments

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)

11A (1) The modifications to the first Directive are as follows. U.K.

(2) Article 8 is to be read as if—

(a) in paragraph 1—

(i) the reference to Member States were a reference to the Authority;

(ii) for “on their territory” there were substituted “in Great Britain”;

(b) paragraphs 2, 3 5 and 6 were omitted.

(3) Article 14 is to be read as if—

(a) in paragraph 1—

(i) the reference to Member States were a reference to the Authority;

(ii) for “within the scope of this Directive” there were substituted “ in accordance with the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 2, the reference to Member States were a reference to the Authority;

(c) in paragraph 3—

(i) the first reference to Member States were a reference to the Authority;

(ii) “in Member States” were omitted.

(4) Article 15 is to be read as if paragraphs 1, 2 and 4 were omitted.

(5) Article 19(5) is to be read as if the words “in accordance with Article 8” were omitted.

(6) Article 20 is to be read as if in paragraph 1, the reference to Article 28(h) were a reference to the requirements of Annex 2 to the third Directive listed in paragraph 11 of this Schedule.

(7) Article 21 is to be read as if—

(a) in paragraph 4, for “laid down in this Directive” there were substituted “ of the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 5—

(i) the first reference to Member States were a reference to the Authority;

(ii) the reference to a tissue establishment accredited, designated, authorised or licensed in accordance with Article 6 were a reference to a tissue establishment authorised or licensed in accordance with the provisions of this Act;

(iii) for the words “Member States' legislation” there were substituted “ legislation ”.

(8) Article 24 is to be read as if—

(a) in paragraph 2, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 5, the reference to the competent authority or authorities were a reference to the Authority.

(9) The Annex is to be read as if—

(a) in paragraph B.1, for “legislation in force in Member States” there were substituted “ requirements of Schedule 3 to the Human Fertilisation and Embryology Act 1990 ”;

(b) paragraph B.2 were omitted.

11B (1) The modifications to the second Directive are as follows. U.K.

(2) Article 2 is to be read as if, in paragraph 1, the reference to Member States were a reference to the Authority.

(3) Articles 3, 4 and 5 are to be read as if any reference to the competent authority or authorities were a reference to the Authority.

(4) Annex 1 is to be read as if, in the first paragraph, for “responsible person as defined in Article 17 of Directive 2004/23/EC” there were substituted “ person responsible in accordance with section 17 of the Human Fertilisation and Embryology Act 1990 ”.

(5) Annex 2 is to be read as if, in paragraph 2.1, the reference to the competent authority in the Member State were a reference to the Authority.

(6) Annex 3 is to be read as if, in paragraph 3.6, for “in force in Member States” there were substituted “ of the Human Fertilisation and Embryology Act 1990 ”.

(7) Annex 4 is to be read as if—

(a) in paragraphs 1.1.1 and 1.2.1, the reference to an authorised person were to—

(i) the person responsible in accordance with section 17 of this Act, or

(ii) a person authorised by the person responsible or the Authority to carry out the specified tasks;

(b) in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “ the Human Fertilisation and Embryology Act 1990 ”;

(c) in paragraph 1.4.4, the reference to the competent authority were a reference to the Authority.

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 ”.]]