Regulation 4B Modifications to the first DirectiveF1

United Kingdom

(1)

The modifications to the first Directive are as follows.

(2)

Article 8 is to be read as if—

(a)

in paragraph 1, the reference to Member States were a reference to the Authority;

(b)

in paragraph 1, for “on their territory” there were substituted “in Great Britain”;

(c)

paragraphs 2, 3, 5 and 6 were omitted.

(3)

Article 10(1) is to be read as if—

(a)

for the reference to “the requirements referred to in Article 28(f)” there were substituted “ the requirements referred to in paragraph 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b)

the reference to the competent authority or authorities were a reference to the Authority;

(c)

for “an annual report on these activities” there were substituted “ a report on these activities upon request ”;

(d)

the words “This report shall be publicly accessible” were omitted.

(4)

Article 14 is to be read as if—

(a)

in paragraph 1—

(i)

the reference to Member States were a reference to the Authority;

(ii)

for “within the scope of this Directive” there were substituted “ in accordance with the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b)

in paragraph 2, for “they” there were substituted “the Authority”;

(c)

in paragraph 3—

(i)

the first reference to Member States were a reference to the Authority;

(ii)

“in Member States” were omitted.

(5)

Article 15 is to be read as if paragraphs 1, 2 and 4 were omitted.

(6)

Article 19(5) is to be read as if the words “, in accordance with Article 8” were omitted.

(7)

Article 20 is to be read as if, in paragraph 1, the reference to Article 28(h) were a reference to the requirements of Annex 2 of the third Directive listed in paragraph 14 of Schedule 2 to these Regulations.

(8)

Article 21 is to be read as if—

(a)

in paragraph 4, for “laid down in this Directive” there were substituted “ of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b)

in paragraph 5—

(i)

the first reference to Member States were a reference to the Authority;

(ii)

the reference to a tissue establishment accredited, designated, authorised or licensed in accordance with Article 6 were a reference to a tissue establishment authorised or licensed in accordance with the provisions of the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or these Regulations;

(iii)

for the words “Member States' legislation” there were substituted “ legislation ”.

(9)

Article 24 is to be read as if—

(a)

in paragraph 2, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b)

in paragraph 5, the reference to the competent authority or authorities were a reference to the Authority.

(10)

The Annex is to be read as if—

(a)

in paragraph B.1, for “the legislation in force in Member States” there were substituted “ the requirements of the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(b)

paragraph B.2 were omitted.

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)