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SCHEDULES

[F1SCHEDULE 3AU.K.SUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION

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

Requirements for holding a licence for gametes and embryo preparation processesU.K.

11U.K.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 establishmentAnnex 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]