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)- Recitals
CHAPTER 1 — SUBJECT-MATTER
CHAPTER 2 — GOOD CLINICAL PRACTICE FOR THE DESIGN, CONDUCT, RECORDING AND REPORTING OF CLINICAL TRIALS
CHAPTER 3 — MANUFACTURING OR IMPORT AUTHORISATION
CHAPTER 4 — THE TRIAL MASTER FILE AND ARCHIVING
CHAPTER 5 — INSPECTORS
CHAPTER 6 — INSPECTION PROCEDURES
CHAPTER 7 — FINAL PROVISIONS
- Final