The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020
| Jurisdiction | UK Non-devolved |
| Citation | SI 2020/1305 |
| Year | 2020 |
2020 No. 1305
Exiting The European Union
Human Tissue
The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020
Made 18th November 2020
Coming into force in accordance with regulation 1
The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1) and 8C of the European Union (Withdrawal) Act 20181.
A draft of this instrument has been approved by a resolution of each House of Parliament, in accordance with paragraphs 1 and 8F2of Schedule 7 to the European Union (Withdrawal) Act 2018.
Citation and commencement
1. These Regulations may be cited as the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020 and come into force immediately before IP completion day.
Amendment of the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
2. The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 20193are amended as follows.
Substitution of regulation 2(2)
3. For regulation 2(2) (amendment of the Human Tissue Act 20044) substitute—
“2. For subsection (3A) substitute—
“(3A) The Authority may not designate a person under subsection (3) if doing so would be incompatible with the principles set out in—
(a)
(a) Article 12 of Directive 2004/23/ECof the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, or
(b)
(b) Article 13 of Directive 2010/53/EUof the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation,
and for the purposes of this subsection as it applies in relation to Great Britain, those Articles of those Directives are to be read subject to the modifications set out in subsections (3B) and (3C).”.”.
Amendment of regulation 3(2)
4. In regulation 3(2)—
(a) for paragraph (b)(i) substitute—
“in the definition of “the Directive”, at the end insert “, as it applies in relation to Northern Ireland”;”;
(b) for paragraph (b)(ii) substitute—
“in the definition of “the Implementing Directive”, at the end insert “, as it applies in relation to Northern Ireland”;”;
(c) in the new paragraph (2) inserted by paragraph (c), after “In these Regulations,” insert “as they apply in relation to Great Britain,”.
Substitution of regulation 3(3)
5. For regulation 3(3) substitute—
“3. For regulation 4 (designation of the competent authority) substitute—
“(4) Designation of the competent authority in relation to Northern Ireland
In relation to Northern Ireland, the Authority is designated the competent authority for the purposes of the Directive.”.”.
Amendment of regulation 3(5)
6. In regulation 3(5), for “these Regulations” substitute “these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland”.
Amendment of regulation 3(6)
7. In regulation 3(6), for “these Regulations” substitute “these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland”.
Substitution of regulation 3(8)
8. For regulation 3(8) substitute—
“8. For regulation 18 (organs sent to or received from another country), substitute—
“(18) (1)
“(18) (1) Where an organ is sent to a Member State from Northern Ireland, the Authority shall ensure that—
(a) information on organ and donor characterisation that is specified in Part A of the Annex to the Directive;
(b) information that has been collected by a registered medical practitioner or a person acting under their supervision that is required by Part B of the Annex at the time...
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