Modifications to the first, second, third and fourth Directives: general4A

For the purposes of these Regulations, the first, second, third and fourth Directives are to be read subject to the modifications set out in regulations 4B to 4E.

Modifications to the first Directive4B

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 “in the United Kingdom”;

iii

paragraphs 2, 3, 5 and 6 were omitted.

3

Article 10(1) is to be read as if—

a

for the reference to “the requirements referred to in Article 28(f)” there were substituted “the requirements referred to in paragraph 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

b

the reference to the competent authority or authorities were a reference to the Authority;

c

for “an annual report on these activities” there were substituted “a report on these activities upon request”;

d

the words “This report shall be publicly accessible” were omitted.

4

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 Tissue (Quality and Safety for Human Application) Regulations 2007”;

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.

5

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

6

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

7

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 of the third Directive listed in paragraph 14 of Schedule 2 to these Regulations.

8

Article 21 is to be read as if—

a

in paragraph 4, for “laid down in this Directive” there were substituted “of the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

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 the Human Tissue Act 2004, the Human Tissue (Scotland) Act 20066 or these Regulations;

iii

for the words “Member States’ legislation” there were substituted “legislation”.

9

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 Tissue (Quality and Safety for Human Application) Regulations 2007”;

b

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

10

The Annex is to be read as if—

a

in paragraph B.1, for “the legislation in force in Member States” there were substituted “the requirements of the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

b

paragraph B.2 were omitted.

Modifications to the second Directive4C

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 “designated individual in accordance with regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

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 Tissue (Quality and Safety for Human Application) Regulations 2007”.

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 designated individual in accordance with regulations 11 and 12 of these Regulations, or

ii

a person authorised to carry out the specified tasks by—

aa

the designated individual, or

bb

the Authority;

b

in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

c

in paragraph 1.4.4 the reference to the competent authority were a reference to the Authority.

Modifications to the third Directive4D

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 “designated individual”;

ii

for “as provided in Article 17 of Directive 2004/23/EC there were substituted “in accordance with the requirements of regulations 117 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

b

in paragraph A.4, for “laid down in this Directive” there were substituted “required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

c

in paragraph C.6, for the words from “the requirements of Council” to the end there were substituted “the requirements of the Medical Devices Regulations 2002”8;

d

in paragraph D.1, for “laid down in this Directive” there were substituted “required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

e

in paragraph E.1, for “laid down in this Directive” there were substituted “required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

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 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 are met”;

c

in paragraph B.3, for the words from “the standards” to the end there were substituted “the requirements of paragraph 13 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

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 paragraph 14 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

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 designated individual in accordance with regulations 11 and 12 of these Regulations;

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 4 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007”.

Modifications to the fourth Directive4E

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 “the United Kingdom”.

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 Tissue (Quality and Safety for Human Application) Regulations 2007”;

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 subparagraph (b) were a reference to the authority 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 1—

i

in the first subparagraph, for “the Union”, in each place where it occurs, there were substituted “the United Kingdom”;

ii

for the second subparagraph, there were substituted “This requirement does not apply to one-off imports as defined in regulation 11(4C)(a) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 provided that the requirements in regulation 11(4B) of those regulations are met.”;

b

in paragraph 2, for “laid down in Directive 2004/23/EC” there were substituted “required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

c

in paragraph 3, the reference to the competent authority or authorities were a reference to the Authority;

d

in paragraph 4, the reference to the competent authority or authorities were a reference to the Authority.

7

Article 8(1) is to be read as if the word “annual” were omitted.

8

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 designated individual in accordance with regulations 11 and 12 of these Regulations;

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 in the third country responsible for regulating tissue establishments in that country.

9

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 2004/23/EC” there were substituted “in accordance with regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007”;

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 in the third country responsible for regulating tissue establishments in that country.

10

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 Tissue (Quality and Safety for Human Application) Regulations 2007”;

b

in paragraph 4, the reference to a third country competent authority or authorities were a reference to the authority 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 a reference 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”9;

e

in paragraph 8, for the words from “requirements” to the end there were substituted “quality and safety standards required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007”.

c

the applicant has provided the Authority with any information or documents as may be specified by the Authority for the purposes of demonstrating—

i

traceability; and

ii

that the import is a one-off import within the meaning of paragraph (4C).

Powers to make regulations in relation to standards of quality and safety34ZA

1

The appropriate authority may by regulations make provision specifying requirements to be met for the purposes of ensuring traceability.

2

The appropriate authority may by regulations make provision in relation to the notification of serious adverse events and reactions (whether to the Authority or such other person as may be specified in the regulations).

3

The appropriate authority may by regulations make provision specifying requirements to be met for the purposes of verifying that standards of quality and safety equivalent to those required by these Regulations apply in relation to imports by tissue establishments of tissues and cells from third countries.

4

The appropriate authority may by regulations prescribe technical requirements in relation to the following—

i

the licensing or authorisation of tissue establishments;

ii

the procurement of tissues or cells;

iii

selection criteria for the donor of tissues or cells;

iv

laboratory tests required for donors;

v

procedures for the reception of tissues and cells at the tissue establishment;

vi

the tissue and cell preparation process;

vii

tissue and cell processing, storage and distribution;

viii

the direct distribution to the recipient of specific tissues and cells.

5

The provision that may be made in regulations under paragraphs (1) to (4) includes provision amending regulations 4A to 4E to modify, or further modify, the provisions of the second, third and fourth Directives as they apply by virtue of these Regulations.

6

In this regulation—

• “appropriate authority” means—

  1. a

     in relation to England, the Secretary of State;

  2. b

     in relation to Wales—

     1. i

        the Welsh Ministers; or

     2. ii

        the Secretary of State acting with the consent of the Welsh Ministers;

  3. c

     in relation to Scotland—

     1. i

        the Scottish Ministers; or

     2. ii

        the Secretary of State acting with the consent of the Scottish Ministers;

  4. d

     in relation to Northern Ireland—

     1. i

        the Department of Health in Northern Ireland; or

     2. ii

        the Secretary of State acting with the consent of that Department;

  5. e

     for the whole of the United Kingdom, the Secretary of State acting with the consent of the Welsh Ministers, the Scottish Ministers and the Department of Health in Northern Ireland.

Scope and nature of powers34ZB

1

Regulations made by the Secretary of State or the Welsh Ministers under regulation 34ZA are to be made by statutory instrument.

2

For regulations made under regulation 34ZA by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 201025 (Scottish statutory instruments).

3

Any power of the Department of Health in Northern Ireland to make regulations under regulation 34ZA is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 197926.

4

Any power in regulation 34ZA to make regulations includes a power to make—

a

different provision for different purposes;

b

consequential, supplementary, incidental, transitional, transitory or saving provision.

Scrutiny of regulations34ZC

1

A statutory instrument containing regulations made by the Secretary of State under regulation 34ZA may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.

2

A statutory instrument containing regulations made by the Welsh Ministers may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, the National Assembly for Wales.

3

Regulations made by the Scottish Ministers under regulation 34ZA are subject to the affirmative procedure (see section 29 of the Interpretation and Legislative Reform (Scotland) Act 2010).

4

Regulations made under regulation 34ZA by the Department of Health in Northern Ireland may not be made unless a draft of the regulations has been laid before and approved by resolution of the Northern Ireland Assembly