What does an application for a biosafety certificate include?

Article overview

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 certificate
Biosafety certificate

What is biosecurity?

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.

Conditions for issuance of Biosafety Certificate

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:

  • Regarding facilities: The facility must have a laboratory that meets biosafety standards. The laboratory must be designed and built according to specifications, with a standard air and wastewater treatment system.
  • Regarding equipment: The facility must be fully equipped with testing equipment, personal protective equipment and disinfection equipment appropriate to biosafety levels. Equipment must be maintained and serviced periodically.
  • Regarding personnel: The facility must have enough staff trained in biosafety. The person responsible for biosafety must be trained in biosafety at level I, level II, level III, and level IV. Testing staff must have a diploma or training certificate appropriate to the type of testing, and operating technical staff must have a training certificate appropriate to operating the testing area;
  • Regarding processes: The facility must develop and implement standard procedures on biosafety, incident handling and waste management. These processes must be updated regularly.

Authority to issue Biosafety Certificates

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:

  • The Minister of Health appraises, renews, reissues and revokes Certificates of testing facilities meeting biosafety standards for level III testing facilities (hereinafter referred to as Safety Certificates). biology), except for testing facilities under the management authority of the Ministry of National Defense.
  • The Minister of National Defense, based on the provisions of this Decree, organizes the appraisal, issuance, re-issuance and revocation of Biosafety Certificates for testing facilities under his management authority.
  • The testing facility self-declares itself to meet level I and level II biosafety standards. Based on the facility’s self-declaration document, the Department of Health posts on its website a list of testing facilities that meet level I and level II biosafety standards.
 Authority to grant biosafety
Authority to grant biosafety

Procedures for applying for a Biosafety Certificate

Proposal profile

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:

  • Application for issuance of Biosafety Certificate according to Model number 02 in the Appendix issued together with Decree 103/2016/ND-CP;
  • Personnel declaration according to Form No. 03 in the Appendix issued with Decree 103/2016/ND-CP;
  • Equipment declaration according to Form No. 04 in the Appendix issued with Decree 103/2016/ND-CP;
  • Certified copies of documents proving the establishment and operation of the testing facility according to the provisions of law;
  • For testing facilities operating before the effective date of this Decree, they must have wastewater testing results that meet national technical environmental standards before discharging into the general wastewater storage area;
  • Maintenance reports on testing equipment for testing facilities operating before the effective date of this Decree;
  • Plans for preventing and handling biosecurity incidents.
 Biosafety certificate
Biosafety certificate

Process and procedures for issuance of 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.

Support service for applying for a biosafety certificate

Long Phan provides you with comprehensive support services in applying for a biosafety certificate. Our services include:

  • Evaluate the current situation of the facility to determine the possibility of applying for a certificate.
  • Consulting on renovating and upgrading facilities to meet the necessary criteria.
  • Prepare documents to request certification.
  • Support in drafting related documents.
  • Representing clients in working with state agencies.
  • Explain documents upon request from state agencies.
  • Monitor the processing of customer documents.
  • Receive results and hand them over to customers.

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.