Regulation 4D Modifications to the third DirectiveF1

United Kingdom

(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 ”.

Annotations

Textual amendments

F1: Regs. 4A-4E inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(4) (as amended by S.I. 2020/1306, regs. 1, 6); 2020 c. 1, Sch. 5 para. 1(1)