Paragraph 13
Directions shall be given for the purpose of securing compliance with 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 | |
|---|---|
| Organisation and management (requirements as to organisational structure, management systems, and third party agreements) | Annex I, Part A |
| Personnel (number, competence, responsibilities and training) | Annex I, Part B |
| Equipment and materials (appropriate for use, validation, maintenance, and specifications) | Annex I, Part C |
| Facilities and premises (suitability, environment, storage, and maintenance) | Annex I, Part D |
| Documentation and records (standard operating procedures, document control, record reliability) | Annex I, Part E |
| Quality review (quality management system, investigations, corrective action, and reviews) | Annex I, 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)