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Biosafety certificate is an important legal document for testing facilities. It confirms the facility meets standards for facilities, equipment, personnel and safe operating procedures. The issuance of this certificate complies with strict regulations of the law to ensure safety in testing activities. The following article will provide detailed information about documents, procedures and biosafety certificate issuance process.
Biosafety is a system of measures to prevent, control and eliminate pathogens in laboratory environments, including the protection of humans, animals and the environment from risks associated with exposure to hazardous biological agents.
Biosafety requires testing facilities to have appropriate facilities, equipment and procedures. Employees must be trained in safe practices and use of personal protective equipment. Facilities need to have effective waste treatment and infection control systems.
According to Article 5, Article 6, Article 7, Article 8 of Decree 103/2016/ND-CP regulating conditions to ensure biosafety at testing facilities, some points are abolished according to Clause 1, Article 14 of Decree. Decision 155/2018/ND-CP. To be granted a Biosafety Certificate, the testing facility must meet the following conditions:
According to Article 10 of Decree 103/2016/ND-CP regulations on ensuring biosafety in laboratories, amended by Point d, Clause 1, Article 15 of Decree 155/2018/ND-CP. The authority to issue, re-issue, self-declare and revoke the Certificate of testing facilities meeting biosafety standards is as follows:
According to Clause 1, Article 11 of Decree 103/2016/ND-CP regulating “Dossier to request new issuance or re-issuance of Biosafety Certificate”, amended by Point dd, Clause 1, Article 15 of Decree 155/ 2018/ND-CP stipulates “Amending and supplementing a number of regulations in the field of infection prevention and control”. Dossier to request a new Biosafety Certificate:
Pursuant to Clause 2, Article 12 of Decree 103/2016/ND-CP regulations on ensuring biosafety in laboratories:
The process for issuing a Biosafety Certificate includes the following steps:
Step 1: The facility submits the application to the standing unit (Department of Health Environmental Management – Ministry of Health).
Step 2: The unit directly receives and sends the application receipt form to the facility.
Step 3: Within 10 days, the permanent unit evaluates the dossier. If the dossier is incomplete, the unit will notify the additional facility in writing within 5 working days.
Step 4: If the dossier is complete, the permanent unit will organize an appraisal at the facility within 10 days.
Step 5: If the facility meets the conditions, the permanent unit reports to the Minister of Health to issue a Certificate within 7 working days from the date of appraisal at the facility.
Step 6: If the facility does not meet the conditions, the permanent unit notifies the facility within 7 working days.
The maximum processing time is 27 working days if the application is complete and the facility meets the conditions from the beginning.
Long Phan provides you with comprehensive support services in applying for a biosafety certificate. Our services include:
Biosafety certificate is an important legal document for testing facilities. The process of applying for this certificate requires careful preparation of documents and must meet the specified criteria. If you need help with procedures for issuing biosafety certificates, please contact Long Phan PMT via hotline number. 0906735386 for specific advice and dedicated support.
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