Paragraph 14
In respect of tissue and cell preparation processes, directions shall be given for the purpose of securing compliance with—
the requirements of Article 20(2) and (3) (tissue and cell processing) and Article 21(2) to (4) of the first Directive, and
the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.
| Relevant provisions of the third Directive | |
|---|---|
| Reception of tissue and cells at the tissue establishment | Annex II, Part A |
| Processing of tissue and cells (validation, documentation and evaluation of critical procedures) | Annex II, Part B |
| Storage and release of tissue and cells (criteria to be complied with, including standard operating procedure) | Annex II, Part C |
| Distribution and recall of tissue and cells (criteria to be complied with, including procedures to be adopted) | Annex II, Part D |
| Final labelling of tissue and cells containers for distribution (information to be shown on container label or in accompanying documentation) | Annex II, Part E |
| External labelling of the shipping container (information to be shown on label on shipping container) | Annex II, Part F |
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)