Paragraph 1ZA F1

In relation to Northern Ireland, directions shall require that licence holders adopt such systems as the Authority considers appropriate to secure—

(a)

in relation to traceability, compliance with the requirements of Article 8 (traceability) of the first Directive and Article 9 (traceability) of the third Directive, and

(b)

in relation to the coding of information, compliance with—

(i)

the requirements of paragraph 1 of Article 25 of the first Directive (coding of information);

(ii)

the requirements of paragraph 1 of Article 10 of the third Directive (European coding system), subject to any exemption specified in the directions in accordance with paragraph 3 of that Article;

(iii)

the requirements of Article 10a of the third Directive (format of the Single European Code); and

(iv)

the requirements of paragraph 1(a) to (f) and (h) of Article 10b of the third Directive (requirements related to the application of the Single European Code).

Annotations

Textual amendments

F1: Sch. 2 para. 1ZA 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(21)(aa) (as inserted by S.I. 2020/1306, regs. 1, 25(b)); 2020 c. 1, Sch. 5 para. 1(1)

Notes on Schedule 2

Textual amendments

F1: Sch. 2 restricted (temp.) (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 4 (as amended by S.I. 2020/1306, regs. 1, 26(b)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Sch. 2 heading substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 8(1)(a)