# The Human Tissue (Quality and Safety for Human Application) Regulations 2007, Regulation 4D: Modifications to the third Directive

Extent: E+W+S+N.I.

(1) The modifications to the third Directive are as follows.
(2) Annex 1 is to be read as if—
(a) in paragraph A.1—
(i) for “responsible person” there were substituted “ designated individual ”;
(ii) for “as provided in Article 17 of Directive 2004/23/EC there were substituted “ in accordance with the requirements of regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;
(b) in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;
(c) in paragraph C.6, for the words from “the requirements of Council” to the end there were substituted “ the requirements of the Medical Devices Regulations 2002 ”;
(d) in paragraph D.1, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;
(e) in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;
(f) in paragraph E.8, the reference to the competent authority were a reference to the Authority.
(3) Annex 2 is to be read as if—
(a) in the first paragraph the reference to the competent authority were a reference to the Authority;
(b) in paragraph A, for the words from “the tissues and cells must” to the end there were substituted “ tissue establishment procedures must ensure that the licence conditions in paragraph 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 are met ”;
(c) in paragraph B.3, for the words from “the standards” to the end there were substituted “ the requirements of paragraph 13 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;
(d) in paragraph B.8, the second sentence were omitted;
(e) in paragraph C.2, for “laid down in this Directive” there were substituted “ of paragraph 14 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;
(f) in paragraphs C.4 and C.5, any reference to the responsible person as defined or specified in Article 17 of Directive 2004/23/EC were a reference to the designated individual in accordance with regulations 11 and 12 of these Regulations;
(g) in paragraph D.5, the reference to the competent authority were a reference to the Authority;
(h) in paragraph E.2(h), for “as set out in Articles 5 to 6” there were substituted “ in accordance with paragraph 4 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”.

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Source: https://www.legislation.gov.uk/uksi/2007/1523/regulation/4D (the official version)
Page: https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4D
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.