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EU Guidance CT1 (R1) – Regulatory Framework

Safety related to a clinical trial or human experience with the investigational medicinal product

Results of new clinical pharmacology tests

New interpretation of existing clinical pharmacology tests

Results of new clinical trials

New interpretation of existing clinical trial data

New data from human experience with the investigational medicinal product

New interpretation of existing data from human experience with the investigational medicinal product

Annex 1: Application Form

REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY

[Forms not included]

Annex 2: Notification of Amendment Form

REQUEST FOR AUTHORISATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY

[Forms not included]

Annex 3: Declaration of the end of trial form

DECLARATION OF THE END OF A CLINICAL TRIAL

[Forms not included]


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