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Schedule 2 Directions for securing compliance with the first, second, third and fourth DirectivesF1F2

United Kingdom

  1. Traceability and coding system
  2. Reporting obligations
  3. Serious adverse events and serious adverse reactions
  4. Third party agreements and termination of licensed activities
  5. Procurement and use of tissue or cells
  6. Selection criteria and laboratory tests required for donors of tissues and cells
  7. Donation and procurement procedures and reception at the tissue establishment
  8. Requirements for holding a licence under Schedule 1
  9. 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)