The Human Tissue (Quality and Safety for Human Application) Regulations 2007

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Interpretation of other termsU.K.

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5.—(1) In these Regulations—

“the 2004 Act” means the Human Tissue Act 2004 M1;

[F1“the Authority” means the Human Tissue Authority;]

“autologous graft” means tissue or cells removed from and applied in the same person within the same surgical procedure;

“blood” means whole human blood collected from a donor and processed either for transfusion or for further manufacturing;

“blood component” means a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods, but does not include lymphocytes intended for use for the purpose of haematopoietic stem cell transplantation;

[F2“a case of emergency” means any unforeseen situation in which there is no practical alternative other than to urgently import F3... from a third country or to export from the United Kingdom to a third country tissues or cells for immediate application to a known recipient whose health would otherwise be seriously endangered;]

“the commencement date” means 5 July 2007;

“cells” means individual human cells or a collection of human cells when not bound by any form of connective tissue, including cell lines grown outside the human body but not including—

(a)

gametes,

(b)

embryos outside the human body, or

(c)

blood and blood components;

“designated individual”, in relation to a licence under Schedule 1, means the individual designated in the licence as the person under whose supervision the licensed activity is authorised to be carried on;

[F2“distribution” in relation to tissues or cells intended for human application means transportation or delivery to any person in or outside the United Kingdom for human application, and related terms are to be interpreted accordingly;]

F4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“human application”, in relation to tissue or cells, means use on or in a human recipient, including use in extracorporeal applications but not including use for autologous graft;

F4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F2“importing licence holder” means a licence holder who is authorised by that licence to import tissues or cells intended for human application F5... from a third country;]

“licence holder” means a person who holds a licence under Schedule 1;

“licensed activity”, in relation to a licence, means an activity which the licence authorises under Schedule 1;

“relevant third party premises” has the meaning given by regulation 6(2);

“serious adverse event” means any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of tissue or cells intended for human application and which, in relation to a donor of tissue or cells intended for human application or a recipient of tissue or cells—

(a)

might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions, or

(b)

might result in, or prolong, hospitalisation or morbidity;

“serious adverse reaction” means an unintended response, including a communicable disease, in a donor of tissue or cells intended for human application or a recipient of tissue or cells, which may be associated with the procurement or human application of tissue or cells and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity;

“storage” means maintaining tissue or cells, whether by preservation or in any other way, for more than 48 hours, and “store” is to be interpreted accordingly;

“tissue” means all constituent parts of the human body formed by cells, but does not include—

(a)

gametes,

(b)

embryos outside the human body, or

(c)

organs or parts of organs if it is their function to be used for the same purpose as the entire organ in the human body;

[F6"third country” means—

(a)

in relation to the import of tissues or cells into, or the export of tissues and cells from, Great Britain, a country other than the United Kingdom;

(b)

in relation to the import of tissues or cells into Northern Ireland, a country other than Northern Ireland or an EEA state; and

(c)

in relation to the export of tissues or cells from Northern Ireland, a country other than the United Kingdom or an EEA state;]

[F7“third country premises”, in relation to Northern Ireland, means premises in a country other than Northern Ireland or an EEA state on or from which a third country supplier procures, tests, processes, stores, distributes or exports tissues or cells that are intended for import into Northern Ireland for human application;]

[F8“third country supplier” means—

(a)

in relation to tissues or cells intended for import into Great Britain for human application, a person in a country other than the United Kingdom who has an agreement with an importing licence holder for exporting such tissues or cells to Great Britain; and

(b)

in relation to tissues or cells intended for import into Northern Ireland for human application, a person in a country other than Northern Ireland or an EEA state who has an agreement with an importing licence holder for exporting such tissues or cells to Northern Ireland;]

“third party” has the meaning given by regulation 6(2); and

“third party agreement” has the meaning given by regulation 6(1).

[F9“tissue establishment” means a tissue bank or a unit of a hospital or another body which procures, tests, processes, preserves, stores or distributes human tissues and cells;

“traceability” means the ability to—

(a)

identify and locate tissues and cells during any step from procurement to use for human application and disposal;

(b)

identify the donor and recipient of particular tissues and cells;

(c)

identify any person who has carried out any activity in relation to particular tissues and cells; and

(d)

identify and locate all relevant data relating to products and materials coming into contact with particular tissues and cells and which can affect their quality and safety.]

(2) Subject to paragraph (1) and except as otherwise provided in these Regulations, words and expressions used in these Regulations have the same meaning as in Article 3 of the first Directive, Article 1 of the second Directive[F10, Article 2 of the third Directive and Article 2 of the fourth Directive (definitions)].

(3) Subject to paragraphs (1) and (2) and except as otherwise provided in these Regulations, words and expressions used in these Regulations have the same meaning as in the 2004 Act as amended by these Regulations [F11and the Human Fertilisation and Embryology Act 2008].

(4) For the purposes of these Regulations—

[F12(a)a person who, from any premises, controls the provision of services for transporting or delivering tissues or cells to any person in or outside the United Kingdom for human application is to be taken to distribute tissues or cells on those premises; and]

[F13(b)any reference in these Regulations to a requirement of any provision of the first, second, third or fourth Directive—

(i)in the application of these Regulations 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;

(ii)in the application of these Regulations in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed in relation to the procurement, testing, processing, storage, distribution, import or export of tissue or cells intended for human application.]

Textual Amendments

F1Words in reg. 5(1) 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(5)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2Words in reg. 5(1) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 2(4)(a)(i)

F3Words in reg. 5(1) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(ia) (as inserted by S.I. 2020/1306, regs. 1, 7(a)); 2020 c. 1, Sch. 5 para. 1(1)