Reporting and permitting procedures for the installation and operation of facilities utilizing LMO p

Installation and operation report for LMO production process utilization facility

1
Submission of installation and operation report for the production process utilization facility and supporting documents

Request for supplementation Submission

2
Review of submitted documents and compliance with standards
4
Installation and operation of the production process utilization facility

3
Issuance of installation and operation report confirmation for the production process utilization facility

[Processing procedure]

Documents to submit for the installation and operation report of the LMO production process utilization facility

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 Design documents of the production process utilization facility (floor plan) or copies thereof Documents proving the scope of the facility and ownership or usage rights rights (copy of business registration certificate, building register, lease contract if facility is rented) Basic design documents of the safety prevention facility, or a copy of the same (for waste consignment processing, a copy of the waste consignment processing contract) Institutional biosafety guidelines, including internal biosafety management regulations and facility operation procedures 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 Original biological safety facility installation and operation report confirmation Installation and operation inspection results (as specified in the announcement): scale, purpose 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 Original biological safety facility installation and operation report confirmation 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].

- Safety management guidelines for facilities using Level 1 and 2 living modified microorganisms for healthcare purposes

Processing deadline

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

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

License for the installation and operation of facilities using LMO production processes

1
Submission of application form for the installation and operation permit for production process utilization and supporting documents

Submission

2
Review of the suitability of submitted documents and standards

Request for supplementation
3
Supplementary materials

4
On-site inspection
5
Expert review
7
Installation and operation of facilities using production processes (3-year re-confirmation)

6
Notification of the review results

[Processing procedure]

Documents to submit for the installation and operation permit of facilities using LMO production processes

제출서류- 신규허가, 변경신고, 폐쇄신고
Documents to submit
New permit	Application letter for the permit, facility permit application form (as per Enforcement Rules of the LMO Act, government revenue stamp (100,000 KRW)), supporting documents Facility design documents (floor plans) or copies thereof Documents proving the scope of the facility and the rights of ownership or use Basic design documents for safety prevention facilities
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 Change request letter (institution approval), application form for change permit (as per the Enforcement Rules of the LMO Act), supporting documents Original biological safety facility installation and operation report confirmation Installation and operation inspection results (as per the notice form) Documents proving the details of the changes
Change notification	Items for change report Institution name, representative Installation and operation responsible person, biosafety management responsible person, biosafety manager Change report letter (institution approval), application form for change permit (as per the Enforcement Rules of the LMO Act), supporting documents Original biological safety facility installation and operation report confirmation Installation and operation inspection results (as per the notice form) Documents proving the details of the changes
Closure report	Closure report letter (institution approval), facility closure report form (as per the Enforcement Rules of the LMO Act), supporting documents Original biological safety facility installation and operation report confirmation Documents proving the details of the disposal

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

- Safety management guidelines for facilities using level 3 and 4 living modified microorganisms for healthcare

Processing deadline

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

New permit, change permit: Within 60 days
Change report, closure report: Within 10 days