Procedure for reporting biosafety research facilities (Level 1 and 2)

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Procedure for Reporting Biological Safety Research Facilities (Level 1, 2)

When a national or public research institution under the Ministry of Health and Welfare develops living modified organisms or conducts experiments using them, biological safety level 1 and 2 research facilities must report to the Korea Disease Control and Prevention Agency.

  • 1

    Submission of installation and operation report for research facilities

    Request for supplementation Submission
    2

    Submission of installation and operation report for research facilities Request for supplementation Review of submitted documents and compliance with standards

  • 4

    Installation and operation of research facilities

    3

    Issuance of research facility installation and operation confirmation certificate

Submission of documents for biosafety level 1 and 2 research facility notification

제출서류 - 신규신고, 변경신고, 폐쇄신고
Documents to submit
New report New report letter (institution approval), facility report form (as per Enforcement Rules of the LMO Act), supporting documents
  1. Facility design documents (floor plans) or copies thereof
  2. Documents proving the scope of the facility and ownership or usage rights (copy of business registration certificate, building register, lease contract in case of rental)
  3. Basic design documents of the safety prevention facility or a copy of it (in case of waste consignment processing, a copy of the waste consignment processing contract)
  4. Institutional biosafety guidelines, including self-developed biosafety management regulations and facility operation procedures
  5. Installation and operation inspection results (as specified in the announcement); supporting materials (documents, photos, etc.)
Change notification Change report letter (institution approval), facility change report form (as per the Enforcement Rules of the LMO Act), supporting documents
  1. Original biological safety facility installation and operation report confirmation
  2. Installation and operation inspection results (as specified in the announcement): scale, purpose, when the LMO is changed
  3. Documents proving the changes (e.g., business registration certificate, training completion certificate, drawings, guidelines, etc.)
Closure report Closure report letter (institution approval), facility closure report form (as per the Enforcement Rules of the LMO Act), supporting documents
  1. Original biological safety facility installation and operation report confirmation
  2. Documents proving the disposal details (e.g., waste treatment results, meeting results of the committee regarding the disposal of used pathogens, etc.)
The relevant form is attached in the Library [View form].

- Guidelines for the installation and operation of biosafety level 1 and 2 facilities

Processing deadline

deadline (If documents are incomplete, a request for supplementation will be made; submission within 30 days.)

  • New report: Within 60 days
  • Change report, closure report: Within 10 days
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