Regulation 4C Modifications to the second DirectiveF1

United Kingdom

(1)

The modifications to the second Directive are as follows.

(2)

Article 2 is to be read as if, in paragraph 1, the reference to Member States were a reference to the Authority.

(3)

Articles 3, 4 and 5 are to be read as if any reference to the competent authority or authorities were a reference to the Authority.

(4)

Annex 1 is to be read as if, in the first paragraph, for “responsible person as defined in Article 17 of Directive 2004/23/EC” there were substituted “ designated individual in accordance with regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(5)

Annex 2 is to be read as if, in paragraph 2.1 the reference to the competent authority in the Member State were a reference to the Authority.

(6)

Annex 3 is to be read as if, in paragraph 3.6, for “in force in Member States” there were substituted “ of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”.

(7)

Annex 4 is to be read as if—

(a)

in paragraphs 1.1.1 and 1.2.1, the reference to an authorised person were to—

(i)

the designated individual in accordance with regulations 11 and 12 of these Regulations, or

(ii)

a person authorised to carry out the specified tasks by—

(aa)

the designated individual, or

(bb)

the Authority;

(b)

in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “ the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;

(c)

in paragraph 1.4.4 the reference to the competent authority were a reference to the Authority.

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)