SCHEDULES
F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION
Requirements for holding a licence for gametes and embryo preparation processes
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In respect of gametes and embryos preparation processes, licence conditions shall require compliance with—
a
the requirements of Article 20(2) and (3) (tissue and cell processing) and Article 21(2) to (4) of the first Directive, and
b
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 | |
|---|---|
Reception of gametes and embryos at the tissue establishment | Annex II, Part A |
Processing of gametes and embryos (validation, documentation and evaluation of critical procedures) | Annex II, Part B |
Storage and release of gametes and embryos (criteria to be complied with, including standard operating procedure) | Annex II, Part C |
Distribution and recall of gametes and embryos (criteria to be complied with, including procedures to be adopted) | Annex II, Part D |
Final labelling of gametes and embryo containers for distribution (information to be shown on container label or in accompanying documentation) | Annex II, Part E |
External labelling of the shipping container (information to be shown on label on shipping container) | Annex II, Part F |
Sch. 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