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Ethical Compliance

The LAW OF UKRAINE “ON MEDICINES”

Article 7. Clinical trials of medicines.
Article 8. Protection of patient (volunteer) rights. 

The PROCEDURE
of conducting clinical trials and expertizing clinical trial materials.

VIII. Evaluation of ethical, moral and legal aspects of clinical trial.
8.1 Evaluation of ethical, moral and legal aspects of the clinical trial is carried out by the committees on ethics at the medical organizations, where clinical trial is being conducted.
8.4 For evaluating the ethical aspects of clinical trial, Applicant submits such documents to the ethics committee at medical organization:
8.4.5 A copy of conclusion of the Centre, approved by the MoH of Ukraine (if applicable).

The MODEL PROVISION
for Ethics committees at the medical organizations, where clinical trials are conducted.

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