Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detail... (32005L0028)
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance)
- COMMISSION DIRECTIVE 2005/28/EC
- of 8 April 2005
- laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
- (Text with EEA relevance)
- CHAPTER 1
- SUBJECT-MATTER
- Article 1
- CHAPTER 2
- GOOD CLINICAL PRACTICE FOR THE DESIGN, CONDUCT, RECORDING AND REPORTING OF CLINICAL TRIALS
- SECTION 1
- GOOD CLINICAL PRACTICE
- Article 2
- Article 3
- Article 4
- Article 5
- SECTION 2
- THE ETHICS COMMITTEE
- Article 6
- SECTION 3
- THE SPONSORS
- Article 7
- SECTION 4
- INVESTIGATOR’S BROCHURE
- Article 8
- CHAPTER 3
- MANUFACTURING OR IMPORT AUTHORISATION
- Article 9
- Article 10
- Article 11
- Article 12
- Article 13
- Article 14
- Article 15
- CHAPTER 4
- THE TRIAL MASTER FILE AND ARCHIVING
- Article 16
- Article 17
- Article 18
- Article 19
- Article 20
- CHAPTER 5
- INSPECTORS
- Article 21
- Article 22
- CHAPTER 6
- INSPECTION PROCEDURES
- Article 23
- Article 24
- Article 25
- Article 26
- Article 27
- Article 28
- Article 29
- Article 30
- CHAPTER 7
- FINAL PROVISIONS
- Article 31
- Article 32
- Article 33
Feedback