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The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014
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Statutory Instruments
2014 No. 2883
Human Tissue
The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014
Made
29th October 2014
Laid before Parliament
7th November 2014
Coming into force
15th December 2014
The Secretary of State is a Minister designated(1) for the purposes of section 2(2) of the European Communities Act 1972(2) in relation to health protection measures regulating the use of material of human origin.
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972.
Citation and commencement
1. These Regulations may be cited as the Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014 and come into force on 15th December 2014.
Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007
2. In regulation 4 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007(3) (references to Directives), in the definition of “the second Directive”, after “cells,” insert “as amended by Commission Directive 2012/39/EU(4),”.
Signed by authority of the Secretary of State for Health.
Jane Ellison
Parliamentary Under-Secretary of State,
Department of Health
29th October 2014
EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations amend the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (“Principal Regulations”) in order to transpose Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells (“the Amending Directive”).
Regulation 2 amends the definition of “the second Directive” (Directive 2006/17/EC) in regulation 4 of the Principal Regulations to include the changes brought about by the Amending Directive.
An impact assessment has not been produced for this instrument as no impact on the private or voluntary sectors is foreseen.
(1)
(2)
(3)
S.I. 2007/1523. There are amendments not relevant to this instrument.
(4)
OJ No L 327, 27.11.2012, p24.
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