SCHEDULES

F1SCHEDULE 3AARequirements where gametes or embryos imported from third country

Annotations:
Amendments (Textual)
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)

F2Modifications to the fourth Directive

Annotations:
Amendments (Textual)

3A

1

The modifications to the fourth Directive are as follows.

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 ”.