European Commission 8 April 2005, 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)

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European Union · · · Cited by 260 · 08-04-2005

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.

9.4.2005

Official Journal of the European Union

L 91/13

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)

THE

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