The Human Tissue (Quality and Safety for Human Application) Regulations 2007
| Jurisdiction | UK Non-devolved |
| Citation | SI 2007/1523 |
| Year | 2007 |
(1) These Regulations may be cited as the Human Tissue (Quality and Safety for Human Application) Regulations 2007.(2) Except as provided by paragraph (3) , these Regulations shall come into force on 5 July 2007.(3) These Regulations shall come into force on the day after the day on which they are made so far as necessary to enable anything (including the fixing of fees) to be done for the purposes of granting, varying, suspending or revoking licences in respect of activities required by virtue of these Regulations to be authorised by a licence on the commencement date.(1) These Regulations extend to England and Wales and Northern Ireland.(2) Parts 1 to 5 and 7 of, and the Schedules to, these Regulations also extend to Scotland.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .the Human Medicines Regulations 2012;the Medical Devices Regulations 2002 the Medicines for Human Use (Clinical Trials) Regulations 2004 (4) Paragraph (3) does not limit the application of the amendments made by Part 6 of these Regulations.The Human Tissue Authority (in these Regulations referred to as “ In these Regulations— (1) In these Regulations—
- “the 2004 Act” means the Human Tissue Act 2004 ;
- “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;
- F33“a case of emergency” means any unforeseen situation in which there is no practical alternative other than to urgently import into the United Kingdom 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;
- F33“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; ............
- “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; .............
- F33“importing licence holder” means a licence holder who is authorised by that licence to import tissues or cells intended for human application into the United Kingdom 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...
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