What are fines for violations against regulations on clinical trial of drugs in Vietnam?

What are fines for  violations against regulations on clinical trial of drugs in Vietnam? (Illustrative photo)

Article 63 of the Decree 117/2020/ND-CP stipulates penalties for violations against regulations on clinical trial of drugs in Vietnam:

1. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

- Disclosing personal information of participants in the clinical trial without their consent;

- Failing to submit reports on clinical trial procedures; failing to publish clinical trial results as prescribed by law;

- Failing to comply with GCP requirements.

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

- Conducting clinical trial without obtaining the scientific and ethical assessment record of the clinical trial dossier from the National Biomedical Ethics Committee and a written approval from the Minister of Health;

- Changing any documents included in the clinical trial dossier or clinical trial outline approved by the Minister of Health.

3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

- Using drugs undergoing clinical trial for other purposes;

- Forging others to participate in clinical trial.

4. The fine shall be twice as much as the fine imposed for the violation in Clause 2 or Clause 3 of this Article but not exceed VND 100.000.000 if the violation involves narcotic drugs, psychotropic drugs or precursor drugs.

Additionally, this Decree stipulates supplementary penalties as follows:

- Revocation of the Certificate of eligibility for pharmaceutical business or suspension of operations for non-commercial establishments for 01 to 03 months for violations specified in points 1 and 2;

- Revocation of the Certificate of eligibility for pharmaceutical business or suspension of operations for non-commercial establishments for 03 to 06 months for violations specified in points 3 and 4.

For more details on other penalties, refer to Decree 117/2020/ND-CP ewhich comes into effect in Vietnam from November 15, 2020.

Ty Na

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE