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Chapter 1 General Provisions

Chapter 2 Authorisation and Notification Procedures for Clin...

Chapter 3 Authorisation and Notification Procedures for Clin...

Chapter 4 Other Clinical Trials

Chapter 5 Registration

Chapter 6 Final Provisions

Annex 1

Annex 2

Annex 3

Annex 4

Annex 5

Annex 6