European Commission 24 March 2017, 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. )

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European Union · · · Cited by 25 · 24-03-2017

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

25.3.2017

Official Journal of the European Union

L 80/7

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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the

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