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Explanatory note

Original text. Later amendments are not shown.

(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.