Reporting of high-risk pathogen handling facilities (Level 1 and 2)

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Procedure for Reporting High-Risk Pathogen Handling Facilities (Level 1 and 2)

  • 1

    Submission of report and supporting documents for the installation and operation of a high-risk pathogen handling facility

    Request for supplementation Submission
    2

    Review of submitted documents, and check of compliance with standards

  • 4

    Establishment and operation of high-risk pathogen handling facilities

    3

    Issuance of confirmation certificate for installation and operation of high-risk pathogen handling facilities

[Processing procedure]

Documents for reporting of biosafety level 1 and 2 high-risk pathogen handling facilities

제출서류, 신규신고, 변경신고, 폐쇄신고 표
Documents to submit
New report New report official document (institutional approval), facility notification form (Enforcement Rule of the Infectious Disease Control and Prevention 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 for rental facility)
  3. Basic design documents of the safety prevention facility or a copy of the same (for consigned waste processing, a copy of the waste consignment 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 Official Document (Institutional Approval), Facility Change Reporting Form (Infectious Disease Control Act Enforcement Regulations), Supporting Documents
  1. Original biological safety facility installation and operation report confirmation
  2. Results of installation and operation inspection (as specified in the announcement): scale, purpose, when the pathogen is changed
  3. Documents proving the changes (e.g., business registration certificate, training completion certificate, guidelines, etc.)
Closure report Closure application letter (institutional approval), facility closure notification form (Enforcement Rules of the Infectious Disease Control and Prevention Act), supporting documents
  1. Original biological safety facility installation and operation report confirmation
  2. Documents proving the disposal (transfer) details (e.g., supporting documents for disposal (transfer) of high-risk pathogens, records of autoclave usage, committee meeting minutes, 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

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

  • New Notification, Change Notification: Within 60 days
  • Closure notification: Within 10 days
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