Circular 567 (French version) describes the legal requirements for production of experimental medicines.
Annex 1 defines a "early phase" trial.
Annex 2 contains the GMP requirements for "early phase" trials.
Annex 3 (French version) is the notification form for requesting authorization for the production of experimental medicines. The form can be sent electronically or by mail to the attention of Division 'Research and Development'.