Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regul... (32017R1569)
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Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance. )
- COMMISSION DELEGATED REGULATION (EU) 2017/1569
- of 23 May 2017
- supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
- (Text with EEA relevance)
- CHAPTER I
- Article 1
- Subject matter
- Article 2
- Definitions
- CHAPTER II
- Article 3
- Conformity with good manufacturing practice
- Article 4
- Compliance with clinical trial authorisation
- Article 5
- Pharmaceutical quality system
- Article 6
- Personnel
- Article 7
- Premises and equipment
- Article 8
- Documentation
- Article 9
- Production
- Article 10
- Quality control
- Article 11
- Retention of samples used for quality control
- Article 12
- Responsibilities of the qualified person
- Article 13
- Outsourced operations
- Article 14
- Complaints, product recall and emergency unblinding
- Article 15
- Self-inspection by the manufacturer
- Article 16
- Advanced therapy investigational medicinal products
- CHAPTER III
- Article 17
- Supervision by inspection
- Article 18
- Cooperation and coordination of inspections
- Article 19
- Recognition of inspection conclusions
- Article 20
- Empowerments of the inspectors
- Article 21
- Competence and obligations of the inspectors
- Article 22
- Quality system
- Article 23
- Impartiality of inspectors
- Article 24
- Access to premises
- Article 25
- Suspension or revocation of manufacturing authorisation
- CHAPTER IV
- Article 26
- Transitional provision
- Article 27
- Entry into force
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