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General
Large scale production, in relation to a biological agent, means the production by any person of the biological agent using equipment at a facility capable of producing in aggregate 10 or more litres of culture of the biological agent at any one time.
Scope or Coverage
Large scale production of Second Schedule biological agents is prohibited.
Approval for large scale produce is required for First and Third Schedule biological agents.
Requirements
The facility must be registered with the Ministry of Health (MOH), and requirements for the type of facility applying for the “approval to large scale produce” will depend on the schedule of the biological agent involved.
List of requirements for large scale production facility
Schedule | Requirements | |||
|---|---|---|---|---|
Approval for Large Scale Production | Possession | Certified Facility | Protected Place | |
First Schedule Part I | Yes* | Yes | Yes | No |
First Schedule Part II | Yes* | Yes | Yes | Yes |
Third Schedule | Yes | No | No | No |
*Under Section 6(3) of the BATA, an operator of an uncertified facility may be granted an approval to possess a First Schedule biological agent if the Director-General of Health is satisfied that any activity involving the use of the First Scheule biological agent can be carried out at the facility in a safe and proper manner. For more information on working with First Schedule biological agents in an uncertified facility, refer to uncertified facility for more details or contact MOH. | ||||
Application
The information and documents to be submitted to the MOH will depend on the schedule of the biological agent.
First Schedule Part I biological agents
Proof that the facility is registered with MOH as a certified or biomanufacturing facility and meets all the biorisk management requirements for the production and/or manipulation of large quantities of biological agent.
Name of the biological agent and proof that the facility has been granted approval to possess the biological agent.
Expected volume of biological agent that will be produced or manipulated in large scale.
Other information and/or supporting documents that the MOH deems necessary in the application.
First Schedule Part II biological agents
Proof that the facility is registered with MOH as a certified or a biomanufacturing facility and meets all the biorisk management requirements for the production and/or manipulation of large quantities of biological agent.
Proof that the facility is gazetted as a protected place under the Infrastructure Protection Act and meet the Physical Security Working Group requirements [PDF, 423 KB].
Proof that the facility has been granted approval approval to possess the agent
Name of the biological agent and proof that the facility has been granted approval to possess the biological agent.
Expected volume of biological agent that will be produced or manipulated in large scale.
Other information and/or supporting documents that the MOH deems necessary in the application.
Third Schedule biological agents
Proof that the facility is registered with MOH as an uncertified or biomanufacturing facility and meets all the biorisk management requirements for the production and/or manipulation of large quantities of biological agent.
Name and quantity of the biological agent to be produced and/or manipulated in large scale.
Other information and/or supporting documents that the MOH deems necessary in the application.
Submit your application for approval to large scale produce via the HALP-Biosafety portal.
Fees
Currently, the MOH does not charge for any fees for the application for approval to large scale produce First or Third Schedule biological agents.
Processing time
The processing time will depend on the accuracy and completeness of the information and supporting documents submitted for the application. Processing of applications are typically completed within 7 working days if all the criteria and/or requirements for the application have been met.
Validity of the approval
The validity of the approval is tied to the validity of the registration of the facility. The MOH may at its discretion, revoke or suspend the approval at any time.
FAQ
Find answers to commonly asked questions on the FAQ page.