SCHEDULES
F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION
Requirements for holding a licence under paragraph 1, 1A or 2 of Schedule 2
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Licence conditions shall require compliance with 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 | |
|---|---|
Organisation and management (requirements as to organisational structure, management systems, and third party agreements) | Annex I, Part A |
Personnel (number, competence, responsibilities and training) | Annex I, Part B |
Equipment and materials (appropriate for use, validation, maintenance, and specifications) | Annex I, Part C |
Facilities and premises (suitability, environment, storage, and maintenance) | Annex I, Part D |
Documentation and records (standard operating procedures, document control, record reliability) | Annex I, Part E |
Quality review (quality management system, investigations, corrective action, and reviews) | Annex I, 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