Permit for high-risk pathogen handling facilities (Level 3 and 4)

Permit procedure for facilities handling high-risk pathogens (BSL-3, BSL-4)

1
Submission of application form and supporting documents for the installation and operation of a high-risk pathogen handling facility

Submission

2
Review of the suitability of submitted documents and standards

Request for supplementation
3
Supplementing materials

4
On-site inspection
5
Expert review
7
Installation and operation of high-risk pathogen handling facility (3-year re-confirmation)

6
Notification of the review results

[Processing procedure]

Documents to submit to apply for a permit to handle high-risk pathogens of biosafety levels 3 and 4

제출서류 - 신규허가, 변경허가, 변경신고, 폐쇄신고 표
Documents to submit
New permit	Official permission application letter, facility permit application form (enforcement regulations of the Infectious Disease Control and Prevention Act), supporting documents Facility design documents (floor plans) or copies thereof 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) Basic design documents for safety prevention facilities Documents of inspections and verifications for the handling facilities listed below A. Inspection report on the operation of biosafety levels 3 and 4 (attached form), including calibration certificates for measuring equipment B. Verification of the facility’s physical containment measures C. Verification of research support facilities such as plumbing, electricity, and gas D. Results of air conditioning and exhaust system verification E. Results of verification of the waste disposal system F. Results of double-door high-pressure steam sterilizer verification G. Results of biological safety cabinet verification H. Results of verification of animal housing equipment (in case of installation) I. Results of verification of biosafety cabinet-style glove box (in case of installation) J. Results of verification of built-in equipment necessary for the containment and operation of other facilities Institutional biosafety guidelines, including self-developed biosafety management regulations and facility operation procedures Status of personnel handling and their technical capabilities
Change permit	Changes to the permit application Changes to the physical structure of the facility Changes to the air conditioning and ventilation system, wastewater treatment system, and automated control system Installation or removal of double-door high-pressure steam sterilizers and major biosafety equipment Changes in the handling of high-risk pathogens, animals, and facility use Change application letter (institutional approval), change permit application form (Enforcement Regulations of the Infectious Disease Control and Prevention Act), supporting documents Original biological safety facility installation and operation permit Installation and operation inspection results report (attached form of the announcement) Documents proving the changes (e.g., change drawings (comparison drawings before and after), change report (comparison photos and verification-related), revised operation guidelines (operation guidelines reflecting the changes))
Change notification	Items for change report Institution name, representative Person responsible for installation and operation, biosafety management officer, person responsible for high-risk pathogen management, biosafety officer Change application letter (institutional approval), change permit application form (Enforcement Regulations of the Infectious Disease Control and Prevention Act), supporting documents Original biological safety facility installation and operation permit Installation and operation inspection results (attached form of the announcement) Documents proving the changes (e.g., business registration certificate, graduation certificate, training completion certificate etc.)
Closure report	Closure application letter (institutional approval), facility closure notification form (Enforcement Rules of the Infectious Disease Control and Prevention Act), supporting documents Original biological safety facility installation and operation permit Documents proving the disposal details (e.g., facility fumigation results, high-risk pathogen disposal, treatment (transfer) results, waste disposal results, committee meeting results, etc.)

The relevant form is attached in the Library [View form].

- Guidelines for installation and operation of biosafety level 3 and 4 facilities, safety management guidelines for biosafety level 3 and 4 facilities, verification guidelines for biosafety level 3 and 4 facilities

Processing deadline

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

New permit, change permit, change notification: Within 60 days
Closure notification: Within 10 days