Procedure and process for the issuance of a new Certificate of Biological Safety

17:02, 10/07/2024

Decree 103/2016/ND-CP has been signed and issued by the Government of Vietnam stipulating regulations on biosafety assurance in laboratories.

The facility with a laboratory shall submit a dossier to the standing unit to be granted a Biological Safety Certificate. The procedure for issuing the certificate is as follows:

- Upon receipt of a valid dossier, the standing unit shall send a receipt note of the dossier to the facility requesting the Biological Safety Certificate;- Within 10 days from the date of receipt of the dossier, the standing unit must appraise the dossier;- In case the dossier is incomplete, within 05 working days from the date of appraisal, the standing unit must notify the facility to complete the dossier;- If the dossier is complete, the standing unit must organize an on-site appraisal at the laboratory within 10 days from the date of appraisal;- In case the laboratory meets all conditions, the standing unit shall report to the Minister of Health to issue the Biological Safety Certificate within 07 working days from the date of on-site appraisal at the laboratory;- If the laboratory does not meet all conditions, the standing unit must notify the facility in writing within 07 working days from the date of on-site appraisal at the laboratory.

View the full text of the regulations at Decree 103/2016/ND-CP effective from July 1, 2016.

- Thanh Lam -

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