SCHEDULES

[F1 SCHEDULE 3AA U.K.Requirements where gametes or embryos imported from third country

Textual Amendments

F1 Sch. 3AA inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Fertilisation and Embryology (Amendment) Regulations 2018 (S.I. 2018/334), regs. 1(3), 5(6)

[F2 Modifications to the fourth Directive U.K.

Textual Amendments

F2 Sch. 3AA para. 3A and cross-headings inserted (31.12.2020) by S.I. 2019/482, regs. 1, 2(18)(c) (with reg. 4) (as amended by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 17(c)); 2020 c. 1, Sch. 5 para. 1(1))

3A (1) The modifications to the fourth Directive are as follows. U.K.

(2) The Directive is to be read as if references to a third country were references to any country other than the United Kingdom.

(3) Article 2 is to be read as if for “the Union”, in each place where it occurs, there were substituted “Great Britain”.

(4) Article 5(1) is to be read as if—

(a) for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) the references to the competent authority or authorities were references to the Authority.

(5) Article 6 is to be read as if—

(a) in paragraph 2—

(i) the reference to the competent authority or authorities were a reference to the Authority;

(ii) the words from “The information laid out” to the end were omitted;

(b) in paragraph 3—

(i) the first reference to the competent authority or authorities were a reference to the Authority;

(ii) the reference to the competent authority or authorities in sub-paragraph (b) were a reference to the authority or authorities in the third country concerned responsible for regulating tissue establishments in that country.

(6) Article 7 is to be read as if—

(a) in paragraph 2, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 3, the reference to the competent authority or authorities were a reference to the Authority.

(7) Annex 1 is to be read as if—

(a) in paragraph A.4, for “TE compendium code” there were substituted “ reference number previously allocated to the tissue establishment by the Authority ”;

(b) in paragraph B.4, the reference to the Responsible Person were a reference to the person responsible in accordance with section 17 of this Act;

(c) in paragraph C.2, the words “(where applicable, in accordance with the EU generic list”) were omitted;

(d) in paragraph F.3, the references to a third country competent authority or authorities were references to the authority or authorities in the third country responsible for regulating tissue establishments in that country.

(8) Annex 3 is to be read as if—

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

(b) in paragraph A.1, for “as laid down in Directive 2004/23EC” there were substituted “ in accordance with sections 16 and 17 of the Human Fertilisation and Embryology Act 1990 ”;

(c) in paragraph A.3, the words “applying the Single European Code,” were omitted;

(d) in paragraph B.7, the reference to a third country competent authority or authorities were a reference to the authority or authorities in the third country responsible for regulating tissue establishments in that country.

(9) Annex 4 is to be read as if—

(a) in paragraph 1, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 4, the reference to a third country competent authority or authorities were a reference to the authority or authorities in the third country responsible for regulating tissue establishments in that country;

(c) in paragraph 5, the reference to the competent authority or authorities were to the Authority;

(d) in paragraph 7, for “EU data protection rules” there were substituted “ data protection legislation within the meaning of section 3(9) of the Data Protection Act 2018 ”;

(e) in paragraph 8, for the words from “requirements” to the end there were substituted “ quality and safety standards required by the Human Fertilisation and Embryology Act 1990 ”.]]