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Statutory Instruments

2014 No. 2884

Human Fertilisation And Embryology

The Human Fertilisation and Embryology (Quality and Safety) 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 Fertilisation and Embryology (Quality and Safety) Regulations 2014 and come into force on 15th December 2014.

Amendment of the Human Fertilisation and Embryology Act 1990

2.  In section 1A of the Human Fertilisation and Embryology Act 1990(3)(reference 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 Fertilisation and Embryology Act 1990 (“the 1990 Act”) 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 section 1A of the 1990 Act to include the changes brought about by the Amending Directive.

A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Department of Health, Richmond House, 79 Whitehall, London SW1A 2NS and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.

(3)

1990 c.37. Section 1A was inserted by regulation 5 of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522).

(4)

OJ No L 327, 27.11.2012, p24.