2B

Any reference in this Act to a requirement of a provision of the first, second, third or fourth Directive—

a

in the application of this Act in relation to Great Britain, is to be read as a reference to a requirement which that provision would require to be imposed if the provision formed part of the law of England and Wales or Scotland, and

b

in the application of this Act in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed.

4

“Third country” means—

a

in relation to the import of qualifying gametes or embryos into, or the export of qualifying gametes or embryos from, Great Britain, a country other than the United Kingdom,

b

in relation to the import of qualifying gametes or embryos into Northern Ireland, a country other than Northern Ireland or an EEA state, and

c

in relation to the export of qualifying gametes or embryos from Northern Ireland, a country other than the United Kingdom or an EEA state.

5

Premises are “third country premises” if—

a

in relation to Great Britain—

i

they are in a country other than the United Kingdom, and

ii

they are premises in 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 Great Britain, and

b

in relation to Northern Ireland—

i

they are in a country other than Northern Ireland or an EEA state, and

ii

they are premises in 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 Northern Ireland.

6

“Third country supplier” means—

a

in relation to qualifying gametes or embryos intended for import into Great Britain, a person in a country other than the United Kingdom who has an agreement with an importing licensee for exporting such gametes or embryos into Great Britain, and

b

in relation to qualifying gametes or embryos intended for import into Northern Ireland, a person in a country other than Northern Ireland or an EEA state who has an agreement with an importing licensee for exporting such gametes or embryos into Northern Ireland.

3

In relation to Northern Ireland, the Authority must take steps to enable the information specified in Annex VIII to be recorded in the EU Tissue Establishment Compendium in relation to each holder of a relevant licence.

5

The Authority must take the steps mentioned in subsection (3) to enable the information mentioned in that subsection to be recorded before the end of the period of 10 working days beginning with the day on which the person becomes the holder of a relevant licence.

• “relevant state” means an EEA State,

4

Directions may authorise any person to whom a licence applies to—

a

receive gametes, embryos or human admixed embryos—

i

from outside the United Kingdom, and

ii

in respect of Northern Ireland, from Great Britain, or

b

send gametes, embryos or human admixed embryos outside the United Kingdom,

in such circumstances and subject to such conditions as may be specified in the directions.

4ZA

Directions made by virtue of subsection (4) may provide for sections 12 to 14 of this Act to have effect with such modifications as may be specified in the directions.

4AD

Where the Authority gives any directions under subsection (4) authorising any person to whom a licence applies to make any qualifying imports, it must—

a

in relation to Great Britain, provide that person with a certificate of authority in such form as the Authority considers appropriate; and

b

in relation to Northern Ireland, provide that person with a certificate in the form set out in Annex II to the fourth Directive.

Tissue establishment

Section 2(1)

A1

For the purposes of this Act, F20as it applies in relation to Great Britain, the first, second and third Directives are to be read subject to the modifications set out in paragraphs 11A to 11C.

Serious adverse events and serious adverse reactions: Northern Ireland3A

In relation to Northern Ireland, licence conditions shall require such—

a

systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and

b

accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,

to be in place as are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.

Modifications to the first, second and third Directives11A

1

The modifications to the first Directive are as follows.

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 “F22in 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.

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.

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 ”M8 ;

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 ”.

A1

For the purposes of this Act, F23as it applies in relation to Great Britain, the fourth Directive is to be read subject to the modifications set out in paragraph 3A.

Directions

F24c

provide the Authority—

i

in relation to Great Britain, with any information or documents specified in the direction for the purposes of demonstrating traceability, and that the import is a one-off import within the meaning given by section 24(4AE),

ii

in relation to Northern Ireland, with any information or documents specified in the direction for the purposes of securing compliance with the requirements of Articles 5(2) and 7(1) of the fourth Directive (requirements in relation to one-off imports).

Modifications to the fourth Directive3A

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 “F25Great 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 ”M10 ;

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 ”.

Interpretation of this Schedule