Information and Guidelines

Facility Registration and Reference Materials for Facility Certification/Audit

1. High Containment (Biosafety Level 3) Facility

   1. Instructions to MOH-AFCB and Facility Owner

   2. SS696:2023 Specification for High Containment (Biosafety Level 3) Facility

   3. High (Biosafety Level 3) Containment Certification Checklist

2. Maximum Containment (Biosafety Level 4) Facility

   1. Instructions to MOH-AFCB and Facility Owner

   2. National Biosafety Standard for Maximum (Biosafety Level 4) Containment Facility

3. Biomanufacturing or Large-scale Production Facility

   1. Instructions to MOH-AFCB and Facility Owner (to be made available in future)

   2. Biorisk Management Standard for Large-Scale Work With Biological Agents

4. Containment (Biosafety Level 2) Facility

   1. Instructions to MOH-AFCB and Facility Owner

   2. Enhanced Biosafety Level 2 Containment Facility Audit Checklist

5. Guidance Document for Development of Facility Administrative Oversight Plan

6. List of MOH-Approved Facility Certification Body

Genetically Modified Organisms

1. Multi-Agency Joint Circular on Guidelines for Research, Release, and Importation of GMOs

Healthcare Application Licensing Portal (HALP) Biosafety Module

1. Healthcare Application Licensing Portal

2. Healthcare Application Licensing Portal Biosafety (HALP-Biosafety) Training Slides and Facility User Guides

Importation, Transhipment, Transportation and Packaging

1. Guidelines on the Import and Transhipment of Biological Agents and Toxins

2. IATA Guidance Document for Transport of Infectious Substances

3. Import Advisory for Importers, Freight Forwarders and End-users of Biological Agents and Toxins

4. List of Biological Agents & Toxins

5. WHO Guidance on Regulations for the Transport of Infectious Substances

International Guidelines/Resources

1. Canada Biosafety Guidelines

2. CDC and NIH: Biosafety in Microbiological and Biomedical Laboratories 6th Ed

3. National Institutes of Health: Biosafety Level 3-Laboratory Certification Requirements

4. WHO Laboratory Biosafety Manual 3rd Edition

5. WHO Laboratory Biosafety Manual 4th Edition

Protected Place and Physical Security

1. Application for Gazette or De-Gazette as a protected place and Personnel Vetting

2. Circular on Physical Security for Facilities Handling First Schedule Part I, Third Schedule and Fourth Schedule biological agents under the Biological Agents and Toxins Act.

3. Annex A: Guidelines for Required Security Measures at Facilities Storing Tier 1 Security Sensitive Materials/Hazardous Materials

Note: Facilities are advised to approach MOH Biosafety Branch for the inspection checklist.

Risk Assessment

1. Risk Assessment Guidelines

2. Risk Assessment Sample Template