Paragraph 10 F1
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 |
Annotations
Textual amendments
- F1
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