Textual Amendments
F1Sch. 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)
F2Sch. 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)
12. In respect of—U.K.
(a)donation and procurement procedures, and
(b)the reception of tissue and cells at premises specified in a licence under Schedule 1,
directions shall be given for the purpose of securing compliance with the requirements of Article 15(3) (selection, evaluation and procurement) and Article 19(4) to (6) (tissue and cell reception) of the first Directive and with the requirements laid down in the provisions of the second 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 second Directive | |
|---|---|
| 1. Donation and procurement procedures | |
| Consent and donor identification (record of consent, method of identification, donor interview) | Annex IV, point 1.1 |
| Donor evaluation: other than autologous donors (assessment of donor's medical and behavioural information and physical examinations) | Annex IV, point 1.2 |
| Procurement procedures for tissue and cells (requirements relating to procurement procedures and instruments) | Annex IV, point 1.3 |
| Donor documentation (record of donor and the procurement) | Annex IV, point 1.4 |
| Packaging (requirements as to packaging and shipping containers) | Annex IV, point 1.5 |
| Labelling of the procured tissue and cells (minimum labelling requirements) | Annex IV, point 1.6 |
| Labelling of the shipping container (minimum labelling requirements) | Annex IV, point 1.7 |
| 2. Reception of tissue and cells at the tissue establishment | |
| Verification upon arrival (procedures for verification and requirement for quarantine until verification) | Annex IV, point 2.1 to 2.3 |
| Registration of data | Annex IV, point 2.4 |