Regulation 34ZA Powers to make regulations in relation to standards of quality and safety, Great BritainF1

United Kingdom

(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—

(a)

in relation to England, the Secretary of State;

(b)

in relation to Wales—

(i)

the Welsh Ministers; or

(ii)

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

(c)

in relation to Scotland—

(i)

the Scottish Ministers; or

(ii)

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

(d)

for the whole of Great Britain, the Secretary of State acting with the consent of the Welsh Ministers and the Scottish Ministers.

Annotations

Textual amendments

F1: Regs. 34ZA-34ZC inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(19) (as amended by S.I. 2020/1306, regs. 1, 23); 2020 c. 1, Sch. 5 para. 1(1)