Certificate of Biological Safety: When Is It Revoked?

Decree 103/2016/ND-CP was signed and promulgated by the Government of Vietnam, stipulating regulations on ensuring biosafety in laboratories. The document came into effect on July 01, 2016.

Decree 103/2016/ND-CP stipulates that the Certificate of Biosafety will be revoked in the following three cases:

- After 6 months from the date of issuance of the Certificate of Biosafety if the testing facility is not operational;- The testing facility goes bankrupt, is dissolved, or merges;- Change in the location of the testing area.

According to Decree 103/2016/ND-CP, the competent authority that issued the Certificate of Biosafety decides on the revocation of the Certificate of Biosafety.

Additionally, the level of biosafety incidents is classified under Decree 103/2016/ND-CP as follows:

- A minor biosafety incident is one that occurs within the scope of the testing facility but poses little risk of infecting laboratory personnel, and the testing facility has the capability to control it;- A serious biosafety incident is one that occurs within the scope of the testing facility but poses a high risk of infecting laboratory personnel and the community or an incident that the testing facility does not have the capability to control.

More details can be found in Decree 103/2016/ND-CP effective from July 1, 2016.

- Thanh Lam -

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