Schedule 2 Directions for securing compliance with the first, second, third and fourth DirectivesF1F2
United Kingdom
- Traceability and coding system
- Reporting obligations
- Serious adverse events and serious adverse reactions
- Third party agreements and termination of licensed activities
- Procurement and use of tissue or cells
- Selection criteria and laboratory tests required for donors of tissues and cells
- Donation and procurement procedures and reception at the tissue establishment
- Requirements for holding a licence under Schedule 1
- Requirements for holding a licence under Schedule 1 for tissue and cell preparation processes
Annotations
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)