Approval to Large-scale Produce
Find out more about the requirements for an Approval to Large-scale Produce under the Biological Agents and Toxins Act.
Last updated on 31 October 2026
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
Approval is required for Large-scale Production of First and Third Schedule biological agents.
Large-scale Production of Second Schedule biological agents is prohibited under the Biological Agents and Toxins Act (opens in new tab).
Requirements
Facilities must be registered with the Health Sciences Authority (HSA). Requirements for approval depend on the schedule of the biological agent involved.
Table 1. Requirements for Large-scale Production Facility
Schedule | Requirements | |||
Approval to Large-scale Produce | Approval to Possess | Type of Facility* | Protected Place | |
First Schedule Part 1 | Yes | Yes | Certified Facility | No |
First Schedule Part 2 | Yes | Yes | Certified Facility | Yes |
Third Schedule | Yes | No | Uncertified Facility | No |
*Certified/Uncertified Facility may also be Biomanufacturing Facility. For more details, visit the FAQ – Large-scale Production page. | ||||
Application
Facilities meeting the requirements in Table 1 can apply for Approval to Large-scale Produce biological agents via the Healthcare Application and Licensing Portal-Biosafety Module (HALP-BS (opens in new tab)).
Fees
Currently, HSA does not charge fees for applications to Large-scale Produce First or Third Schedule biological agents.
Processing Time
Processing time depends on the accuracy and completeness of the submission. If all requirements are met, the application is typically processed within 7 working days for registered facilities.
Validity
Approval validity is tied to the facility’s registration validity. HSA may revoke or suspend approval at its discretion.
Frequently Asked Questions
Find answers to common queries on the FAQ page.