Fines for violations against regulations on laboratory biosafety in Vietnam

Fines for violations against regulations on laboratory biosafety in Vietnam (Illustrative image)

Article 8 of Decree 117/2020/ND-CP stipulates penalties for violations against regulations on laboratory biosafety in Vietnam:

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

- Failing to meet one of requirements for biosafety level 1 laboratory after self-declaration of satisfaction of biosafety level 1 laboratory standards;

- Failing to assess risks of biosafety incidents at testing laboratories;

- Performing tests beyond the professional scope after declaration of satisfaction of biosafety level 1 or level 2 laboratory standards;

- Failing to formulate and organize the implementation of regulations on internal biosafety inspection as prescribed by law;

- Failing to make and keep records of handled less serious biosafety incidents at the testing laboratory.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

- Failing to meet one of requirements for biosafety level 2 laboratory after self-declaration of satisfaction of biosafety level 2 laboratory standards;

- Failing to formulate a plan for prevention and handling of biosafety incidents or formulating a plan that does not contain adequate contents as prescribed by law;

- Failing to disinfect or sterilize waste generated from testing activities before putting it into the waste collection system or temporary waste storage area of a biosafety level 2 laboratory.

3. A fine ranging from VND 10,000,000 to VND 20,000,000 shall be imposed for commission of one of the following violations:

- Failing to mobilize or delaying the mobilization of human resources and equipment for handling a biosafety incident according to the plan for prevention and handling of biosafety incidents as prescribed by law;

- Collecting, transporting, maintaining, storing, using, researching, exchanging and destroying pathological samples carrying infectious agents against regulations on management of infectious disease samples;

- Failing to submit reports to the relevant Provincial Department of Health on serious biosafety incidents and measures taken against such incidents.

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

- Failing to meet one of requirements for biosafety level 3 laboratory after obtaining the certificate of satisfaction of biosafety level 3 laboratory standards;

- Maintaining, storing, using, researching, exchanging and destroying samples of a group-A infectious disease without meeting edibility requirements;

- Failing to disinfect or sterilize waste generated from testing activities before putting it into the waste collection system or temporary waste storage area of a biosafety level 3 laboratory.

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

- Failing to organize annual drills of biosafety incident prevention and handling by a biosafety level 3 laboratory;

- Performing tests before completing procedures for self-declaration of satisfaction of biosafety level 1 or level 2 laboratory standards, or before obtaining a certificate of satisfaction of biosafety level 3 laboratory standards, or when the certificate of satisfaction of biosafety level 3 laboratory standards has expired.

More details can be found in Decree 117/2020/ND-CP, effective from November 15, 2020.

Thuy Tram

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