Textual Amendments
F1Sch. 3A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 30
9U.K.In relation to—
(a)donation and procurement procedures, and
(b)the reception of gametes and embryos at the premises to which a licence relates or at relevant third party premises,
licence conditions shall require 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 partner-donated sperm and partner-created embryos and autologous donors (assessment of donor's medical and behavioural information) | Annex IV, point 1.2 |
| Procurement procedures for gametes and embryos (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 gametes and embryos (minimum labelling requirements) | Annex IV, point 1.6 |
| Labelling of the shipping container (minimum labelling requirements) | Annex IV, point 1.7 |
| 2. Reception of tissues and cells at the tissue establishment | |
| Verification upon arrival (procedures for verification and requirement for quarantine until verification) | Annex IV, points 2.1 to 2.3 |
| Registration of data (other than in respect of partner-donated sperm and partner-created embryos) | Annex IV, point 2.4 |
| Registration of data (partner-donated sperm and partner-created embryos) | Annex IV, point 2.5] |