Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed... (32017R0556)
INHALT
Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council (Text with EEA relevance. )
- COMMISSION IMPLEMENTING REGULATION (EU) 2017/556
- of 24 March 2017
- on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council
- (Text with EEA relevance)
- CHAPTER I
- GENERAL PROVISIONS
- Article 1
- Scope
- Article 2
- Time frame for inspections
- Article 3
- Quality system
- CHAPTER II
- INSPECTORS
- Article 4
- Qualifications, training and experience
- Article 5
- Conflict of interest and impartiality
- CHAPTER III
- INSPECTION PROCEDURES
- Article 6
- Subject matter of inspections
- Article 7
- Procedures to be established by Member States
- Article 8
- Unannounced inspections
- Article 9
- Collaboration between Member States
- Article 10
- Powers of inspectors
- Article 11
- Recognition of inspection conclusions
- Article 12
- Resources
- Article 13
- Inspection reports and records
- Article 14
- Confidentiality
- CHAPTER IV
- FINAL PROVISIONS
- Article 15
- Repeal
- Article 16
- Transitional provisions
- Article 17
- Entry into force
Feedback