Special approval to handle is only applicable to Second Schedule biological agents. The application will not be considered unless the following conditions are met:

1. The use of the Second Schedule biological agent is necessary for the public interest; and
2. The person who requires the biological agent has placed adequate measures to contain the risk to public health and security posed by the Second Schedule biological agent.

For First Schedule biological agents, you need to apply for an approval to possess the biological agent first. Your facility needs to meet the requirements to possess the biological agent before MOH consider granting you the approval to engage in large scale production. Once the approval to possess is granted, you may apply for an approval to large-scale produce.

For Third Schedule biological agents, since the approval to possess is not required, you may directly apply for an approval to large-scale produce the biological agent in large quantities.

Although in general, there is no expiry date for the approval to large-scale produce First and Third Schedule biological agents, the validity of the approval is tied to:

1. The facility having a valid “approval to possess” the First Schedule biological agent.
2. The production is carried out at the facility specified in the approval.
3. In accordance with any other conditions stipulated in the approval, and this may include an expiry date.

Additionally, MOH also has the right to revoke any approval granted under the Act.

Yes, an uncertified facility may work with inactivated (First or Second Schedule) biological agents provided by another local facility that is permitted to carry out the inactivation process. In such case, the receiver must practice due diligence in ensuring that the sender has successfully rendered the agent inactive (non-infectious or non-replicative).

An uncertified facility may also import inactivated (First or Second Schedule) biological agents. In the latter case, the importer or recipient (uncertified local facility) need to furnish MOH, the proof of successful inactivation of the biological agent by the overseas laboratory, prior to importation of the agents.

Although the biological agents are deemed to be inactivated, the facility shall remain cautious and treat it as potentially infectious using appropriate biosafety practices and measures.

Should the “inactivated” biological agents be found or suspected to contain live, infectious or replication-competent First or Second Schedule biological agents, facility shall ceased all work on the “inactivated” biological agents, store in a safe and secure manner and notify MOH immediately.

Before carrying out any inactivation of biological agents listed under the First or Second Schedule of the Act, the facility operator has to ensure that:

1. there is a valid approval to possess the biological agent;
2. the inactivation procedure has to be reviewed, endorse or approved by the Biosafety Committee; 
3. the inactivation procedure has been validated or verified effective in rendering the agent non-infectious/non-replicative and the efficacy date and all relevant data is documented and filed;
4. the inactivation procedure is performed at the facility specified in the approval to possess; and
5. a system in place to monitor and to ensure that the inactivation procedure continues to be effective in rending the biological agent non-replicative and non-infectious.

Refer to Section 27 of the Biological Agents and Toxins Act (BATA) for more information.

Facility must submit the following documents to moh_biosafety@moh.gov.sg for consideration:

1. The source of the inactivated biological agent;
2. The name and curriculum vitae of the person who carried out the inactivation;
3. The method of inactivation (procedures) used and its efficacy (validation report with detailed results);
4. The approval from the local Biosafety Committee (BC) with risk assessment;
5. The credentials of the institution which carried out the inactivation ( if the biological agent is coming from an overseas institution);
6. Research proposal or activities to be carried out on the inactivated biological agent;
7. Any other documents that MOH deem necessary in the evaluation proces.

Approval to possess is not required for use and possession of inactivated First or Second Schedule biological agents, if and only if the “inactivated” biological agent has proven to be render non-infectious and unable to replicate under any conditions. It is the laboratory’s responsibility to ensure that the inactivation process is effective and successful.

The inactivated biological agents and their components should not be used to synthesize, modify or make to become infectious or replication competent.

Risk assessments are conducted before the commencement of any work and thereafter, upon any of the conditions below, whichever is earlier:

1. once every 2 years
2. upon occurrence of accidents, near misses, dangerous acts, or
3. when there are changes in work processes, equipment or workplace conditions / layout.

This is to ensure that the measures that were put in place previously are still effective and to assess if there is any need to make changes to the existing measures or implement additional measures.   

There are biological agents that are not listed in the schedules that may also require an import permit.

For biological agents not in the "List of Biological Agents and Toxins" in the Biological Agents and Toxins Act (BATA), you may send an inquiry to moh_biosafety@moh.gov.sg so that we can advise you whether you need to get an import permit for your item.

The application for import permit is done online at Singapore Customs NTP. Applications should preferably be submitted on the NTP at least 5 working days before the biological agents or toxins are due to arrive in Singapore. There are 2 ways of obtaining the import permit:

1. If you have an account with the Singapore Customs NTP, you can apply directly for the import permit provided that you have a Unique Entity Number (UEN) or a Central registration Number (CRN) of your company or institution. The UEN/CRN is required for all import, export and transhipment permits, certificates and other documents issued by the Singapore Customs. For more information, please direct your inquiry to Singapore Customs at 6355 2000 or send an e-mail to customs_documentation@customs.gov.sg.
2. If you do not have a NTP account, you may engage a courier service provider who already has an existing NTP account to apply for the import permit on your institution’s behalf. In this case, it is your responsibility to provide the correct information (e.g. UEN/CRN of your institute, MOH product code, etc.) to the courier. In addition, it is also your responsibility to verify that the permit that the courier has secured is correct and valid before the consignment clears the customs.

The importer (the laboratory or end user of the biological agent or the toxin) is responsible for ensuring that a valid import permit is obtained for the biological agents and toxins. Even if a courier service provider is engaged to apply for an import permit on behalf of the importer (e.g., the laboratory personnel or end user), the importer is responsible for providing the correct information needed for the import permit declaration to the courier service provider, and to ensure that the correct import permit has been obtained from MOH.

You may require the courier service provider to fax the import permit so that you can verify the declaration details on the import permit is correct before authorizing the courier service to bring the goods into Singapore. 

For zoonotic agents, Importers are required to obtain import permit from both AVS and MOH. AVS and MOH have streamlined the import processing workflow as shown in the table below:

                                               ⇩

Application for import permit for zoonotic agents can be done online at the NTP. Please use the following codes: HS code – 30029000 or 21021000; Product Code Field – MOH Product Code and AVS Product Code.

The List of Biological Agents with the MOH product code and the corresponding AVS product code for zoonotics can be found on the Biosafety website.

Please refer to the MOH guidelines for the Importation and Transhipment of Human Pathogens and Toxins.

You may also refer to the Singapore Customs Website or send an e-mail to customs_documentation@customs.gov.sg for more information on import permits.

Table A. Facility Personnel

I.e. inventory related notification and reportable events.

Inventory related notifications include:

1. Notification of Consumption of Fifth Schedule Toxins.
2. Notification of Complete Destruction and/or Disposal of Stock Inventory.
3. Notification of Export (of biological agents or toxins).
4. Notification of Receipt (submitted by receiving facility if the biological agent or toxin is sent by a facility which is NOT registered with HALP-Biosafety).
5. Request for Transfer (submitted by receiving facility if the biological agent or toxin is sent by another facility which is registered with HALP-Biosafety).
6. Notification of Transfer (submitted by sending facility if the biological agent or toxin is sent to another facility which is registered with HALP-Biosafety).
7. Acknowledgement of Receipt of Transfer (submitted by receiving facility if the biological agent or toxin is sent by another facility which is registered with HALP-Biosafety).
8. Notification of Failure to Receive (submitted by receiving facility).

1. Notification of incident/near-miss.

For urgent matters/incidents that require MOH's immediate attention, please contact 9665 4196.

However, you are still required to log in to HALP-Biosafety to submit the notification once it is possible for you to do so.

Any person who needs to work with First Schedule Part 2, Second Schedule biological agents and Fifth Schedule toxins shall have a facility gazetted as a protected place under the Infrastructure Protection Act.

An Application for Gazette to be gazetted as a Protected Place shall be submitted to the Biosafety Branch, MOH stating the justification for such request.

If MOH is satisfied with the justification, MOH will issue a letter of support to the applicant. The applicant can then submit his/her application to be gazetted as a Protected Place, together with MOH letter of support, to the relevant regulatory authority.

Details of the procedures can be found in Application for Gazette or De-gazette as a Protected Place.

Supporting information and/or documents required for the registration/renewal of a certified facility:

1. Facility Administrative Oversight Plan.
2. Facility layout and air-conditioning and mechanical ventilation (ACMV) schematics.
3. Facility biosafety and biosecurity manual.
4. Biosafety committee and biosafety coordinator meeting the requirements in the Biological Agents and Toxins Act.
5. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.
6. List of personnel working in the facility.
7. Certification reports and supporting documents.
8. Approval letters from the relevant authorities (e.g. Public Utilities Board's written approval for discharge of trade effluent into public sewage).
9. Any other documents or information that MOH may deem relevant or necessary for the application.

Supporting documents required for registering a “protected” facility include:

1. Gazette documentation related to protected place status under the Infrastructure Protection Act.
2. Completed Physical Security Workgroup (PSWG) checklist.
3. Biosafety committee and biosafety coordinator meeting the requirements in the Biological Agents and Toxins Act.
4. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.
5. List of vetted personnel working in the facility.
6. Any other documents or information that MOH may deem relevant or necessary for the application.

Supporting documents required for registering/renewing of a “protected” certified facility include:

1. Facility Administrative Oversight Plan.
2. Facility layout and air-conditioning and mechanical ventilation (ACMV) schematic.
3. Facility biosafety and biosecurity manual.
4. Gazette documentation related to protected place status under the Infrastructure Protection Act.
5. Completed Physical Security Workgroup (PSWG) checklist.
6. Biosafety committee and biosecurity coordinator meeting the requirements in the Biological Agents and Toxins Act.
7. Supporting documents (e.g. training and competency certificates) for the biosafety coordinator.
8. List of vetted personnel working in the facility.
9. Certification reports and supporting documents.
10. Approval letters from the relevant authorities (e.g. Public Utilities Board's written approval for discharge of trade effluent into public sewage).
11. Any other documents or information that MOH may deem relevant or necessary for the application.

If the ABSL3 facility is used for the handling or storage of live First and Second Schedule biological agents, then it shall be certified and registered with MOH.

Similarly, other controls, including the possession, large-scale production, inactivation, transfer and transport of First and Second Schedule biological agents and Fifth Schedule toxins in the Act applies to the ABSL3 facility.

Additional criteria may be required by Animal and Veterinary Service (AVS), under the National Parks Board (NParks). You may send your queries to AVS on their website.

Some positive aspects of having facility shut down for recertification include:

1. Allows all personnel to access the facility safely without the need to don personnel protective equipment (PPE). Personnel accessing the facility at this time may include certifiers, controlling authorities, facility maintenance crews who are non-laboratory personnel, and such personnel can carry out their respectively duties freely and safely without being limited by the PPE.
2. Allows more robust and extensive testing and challenging of the facility equipment, engineering and/or ventilation systems without being worried of any possible containment breach and adverse impact to the environment and the surrounding due to test or system failure.
3. Facility can take the shut down time as opportunity to conduct housekeeping, in-house maintenance, servicing, repairing or replacing of equipment, engineering or ventilation parts, and on-site training of staff on emergency responses.  

Individual facility operator shall assess if there is a need for its facility to shut down for re-certification, weighing the benefits and the potential delay or interruption of laboratory services or research, and taking into consideration the facility conditions and safety of personnel involved in the re-certification process.

* Shut-down includes stopping all laboratory activities, storage of all biological agents and toxins safely and securely, and the facility is fully decontaminated.   

Detailed requirements for MOH-AFCB and MOH-AFC can be found in MOH Approved Facility Certifying Body and Facility Certifier.

You may apply online via the Biosafety E-services portal. Alternatively, you may send an e-mail to moh_biosafety@moh.gov.sg indicating your company interest in becoming an MOH-AFCB with the list of the facility certifiers. Documents or information required for the submission can be found in MOH Approved Facility Certifying Body and Facility Certifier.

A facility gazetted as a protected place is required for facilities intending to work or store First Schedule Part II and Second Schedule biological agents and Fifth Schedule Toxins.

Note that for First Schedule Part II and Second Schedule biological agents, that facility must also be a certified BSL-3 facility in addition to it being gazetted as a protected place.

Any person who needs to work with First Schedule Part II, Second Schedule biological agents and Fifth Schedule toxins must have a facility gazetted as a protected place under the Infrastructure Protection Act.

A letter of request to be gazetted as a Protected Place must be submitted to the Biosafety Branch, MOH stating the justification for such request.

If MOH is satisfied with the justification, MOH will issue a letter of support to the applicant. The applicant can then submit his application to be gazetted as a Protected Place, together with MOH letter of support, to the relevant regulatory authority. 

1. Singapore Government Gazette published announcement;
2. List of vetted personnel working in the facility;
3. Completed Checklist for Premises Storing and/or Handling Security Sensitive Materials; and
4. Any other document or information that MOH may deem relevant or necessary for the application.

Application procedures can be found at under the “Useful Info” of this website or you can click here.

Please contact the MOH-Biosafety Branch at moh_biosafety@moh.gov.sg for more details.

All entries to the protected facility must be recorded with the following information: Name of visitor and accompanying security cleared personnel, date and time of entry and exit and the purpose of the visit.

All visitors and no-security cleared staff must always be accompanied by a security cleared facility staff at all times when the visitor and non-security cleared personnel are in the protected facility.

A facility no longer working on First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxin can de-gazette as a protected place. However, prior to degazetting the facility, facility operatory must ensure that there is no First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxins left or in possession in the facility.

The procedure on how to de-gazetted a protected facility can be found in our website under “Useful info”. 

Note that once the facility has been de-gazetted, any future intention of possessing any First Schedule Part II and Second Schedule biological agents or Fifth Schedule toxins will have to undergo a fresh application to be gazetted as a protected place from the relevant regulatory authority and will be subjected to review and assessment by MOH.

You may submit an appeal for approval to possess First Schedule biological agent in an uncertified facility by submitting the following documents to moh_Biosafety@moh.gov.sg for assessment:

1. the name of the First Schedule biological agent, and the associated activities on the biological agent; 
2. the nature of the First Schedule biological agent;
3. the volume of the biological agent that you are going to handle;
4. the importance of the proposed work (e.g., in public health aspect) and justifications of why or how the work could be carried out safely and securely within the facility
5. a biosafety committee and biosafety coordinator meeting the requirements stipulated in the Biological Agents and Toxins Act;
6. risk assessment carried out on the proposed work (by or endorsed by the Biosafety Committee);
7. risk management measures put in place that ensure safety and security of the biological agent and the work; 
8. proof that the uncertified facility is gazetted as a protected place under the Infrastructure Protection Act, if the work involves any First Schedule Part II biological agent; 
9. review or endorsement from Genetic Modification Advisory Committee (GMAC) if work involves genetic modified microorganism or genetic manipulation activity;
10. any other information or supporting documents that may help to support your appeal; and
11. any other information that MOH may deem necessary or relevant.

Item transported	Label
	Biohazard Sign	Toxic Sign
First and Second Schedule Biological Agent	✔	✘
Fifth Schedule toxins	✘	✔
First and Second Schedule biological agents and Fifth Schedule toxin	✔	✔
Third Schedule biological agents	✔	✘

Please refer to the Biological Agents and Toxins Act (Transportation) Regulations for more details.

A driver transporting First, Second, Third Schedule biological agents and Fifth Schedule toxins must be trained and possesses a valid Hazmat Transport Driver Permit (HTDP - Biologicals).  

For information on the Hazmat Transport Driver Permit Course, you may call the SCDF Customer Service Team at 6794-5502/5606 or send your enquiries by e-mail to scdf_cda@scdf.gov.sg.  

In the event of emergency incidents or transport accidents, the driver shall immediately cordon off the area surrounding the vehicle and the spillage/leakage. He should then notify his supervisor and the owner of the biological agent or toxin, SCDF and MOH of the incident.

Please refer to Section 47 of the Biological Agents and Toxins Act (BATA) for more information and the Biological Agents and Toxins (Transportation) Regulations.

It is strictly prohibited to transport any of the scheduled biological agent or toxins, or inactivated biological agent under the Biological Agents and Toxins Act by mail or public transportation.

See section 47 of the Biological Agents and Toxins Act and the Biological Agents and Toxins (Transportation) Regulations for additional requirements for transportation of First, Second and Third Schedule biological agents, and Fifth Schedule toxins.

Yes, you can transfer the biological agent or toxin to the facility (receiving facility or transferee) provided you have ascertained that the transferee has a valid approval to possess the biological agent or toxin, for if the biological agent or toxin falls under the First, Second of Fifth Schedule of the Biological Agents and Toxins Act.

As the sending facility (transferor), you are required to:

1. Notify MOH of the proposed transfer by creating a notification of transfer via the HALP-Biosafety.
2. Notify the transferee of the estimated time of transfer of the agent.
3. Provide the carrier of the agent with a 24-hour emergency number of the person who has the knowledge of the hazards and characteristics of the biological agent or toxin being transported.
4. Remind the transferee to monitor the transfer and to ensure that the schedule agents are received within 24 hours from the expected date and time frame as agreed by both you and the transferee.
5. Remind the transferee to login to HALP-Biosafety to "Acknowledge the receipt of transfer" of the biological agent or toxin if the biological agent or toxin is received within 24 hours from expected date and time. Otherwise, the transferee shall notify MOH of failure to receive of the scheduled biological agent or toxin.

In addition, as a transferor, you are required to ensure that the biological agent, the toxin, and/or the sample is packed and transported in accordance with the transport regulations of Biological Agents and Toxins Act.

More detailed procedures for transferring biological agents or toxins between facilities within Singapore can be found in Point #4 of this section below.

Yes, you can transfer the isolated biological agent and/or the residual sample positive for the biological agent (or toxin) to the facility (receiving facility or transferee) provided you have ascertained that the transferee has a valid approval to possess the biological agent or the toxin.

As the sending facility (transferor), you are required to:

1. Notify MOH of the proposed transfer by sending an e-mail to moh_biosafety@moh.gov.sg.
2. Notify the transferee of the estimated time of transfer of the agent.
3. Provide the carrier of the agent with a 24-hour emergency number of the person who has the knowledge of the hazards and characteristics of the biological agent or toxin being transported.
4. Remind the transferee to monitor the transfer and to ensure that the scheduled agents are received within 24 hours from the expected date and time frame as agreed by both you and the transferee.
5. Remind the transferee to login to HALP-Biosafety to submit a "Notification of receipt" if the biological agent, toxin or the sample is received within 24 hours from the expected date and time. Otherwise, the transferee shall notify MOH of failure to receive of the scheduled biological agent, toxin or the sample.

As a sending facility (transferor), you shall ensure that the biological agent, the toxin, and/or the sample is packed and transported in accordance with the transport regulations of Biological Agents and Toxins Act.

More detailed procedures for transferring biological agents or toxins between facilities within Singapore can be found in Point #4 of this section below.

Under the Biological Agents and Toxins Act (BATA), a receiving facility (transferee) shall notify MOH of the failure to receive if he/she does not receive the consignment within 24 hours of the estimated time of receipt of the agent provided by the sending facility (transferor). Contact MOH at 96654196 and submit a "Notification of Failure to Receive" through the HALP-Biosafety.

The "Notification of Failure to Receive" is mandated for First Schedule Part 2 and Second Schedule biological agents and Fifth Schedule toxins. However, you are also advised to notify MOH of any failure to receive of any other biological agents or toxins listed in any of the BATA Schedule for public health purposes.

Transfer of biological agent between two facilities that are registered in HALP

Step 1: Request for Transfer

1. The receiving facility (transferee) submits a Request for Transfer in the HALP-Biosafety by specifying the name of the sending facility (transferor) and the name of the biological agent or toxin being requested.
2. The system will generate a request code and notify the transferor of the request.

1. The transferor arranges for the transfer and informs the transferee of the expected time of arrival of the biological agent or toxin.
2. The transferor submits a Notification of Transfer in HALP-Biosafety by inputting the request code and relevant details related to the transfer.
3. The system will generate a transfer code and notify the transferee of the upcoming transfer.

1. If the transfer is successfully completed, the transferee submits an Acknowledgement of Receipt in the HALP-Biosafety by inputting the transfer code and details related to the receipt of the materials.
2. If the transferee fails to receive the biological agent or toxin within 24 hours of the expected time of receipt, the transferee submits a Notification of Failure to Receive in the HALP-Biosafety by inputting the transfer code.
3. The transferee shall also submit an Incident Notification in HALP-Biosafety to report the failure to receive.

1. Name of the biological agent/toxin
2. Name of the transferee
3. Expected date and time of transfer and arrival
4. Carrier of the biological agent or toxin

1. If the transfer is successfully completed, the transferee submits a Notification of Receipt (from Facility Not Registered with Biosafety in HALP) in the HALP-Biosafety by inputting the details related to the receipt of the materials.
2. If the transferee fails to receive the biological agent or toxin within 24 hours of the expected time of receipt, the transferee submits a Notification of Failure to Receive in the HALP-Biosafety and specify the details related to the intended transfer.
3. The transferee shall also submit an Incident Notification in HALP-Biosafety to report the failure to receive.

Biosafety Coordinators are required to have attended the structured training course and qualified the examination conducted by the MOH-Approved Training Provider.

In cases wherein you have attended biosafety training courses, other than the one given by the MOH-ATP, you may submit information of the course and proof of participation to moh_biosafety@moh.gov.sg 
MOH will review the application on a case to case basis. 

Training for Biosafety Level 3 Facility (BSL3) staff is mandated under the Biological Agents and Toxins Act. Such training can be conducted in-house or by experienced external trainers.

The facility should maintain proper training records of their staff.  

The Biological Agents and Toxins Act (BATA) only stipulates training requirements for biosafety coordinator working in facility (certified or un-certified) possessing First or Second biological agents, Fifth Schedule toxins or large scale production of Third Schedule biological agents (see answer in question 1).

Personnel (including biosafety coordinator) from facilities that do not possess the scheduled biological agent or toxins mentioned above, although not mandated, are encouraged to attend such training courses.

The Biological Agents and Toxins Act (BATA) only stipulates training requirements for biosafety coordinator working in facility (certified or non-certified) possessing First or Second Schedule biological agents or Fifth Schedule toxins or large scale production of Third Schedule biological agents.

Training of staff from facilities (certified or un-certified), possessing First or, Second Schedule biological agents or Fifth Schedule toxins or large scale production of Third Schedule biological agent is mandated in the Act. However, their training can be conducted in-house or externally by experienced trainers.