1. General

Large Scale Production Facility refers to a facility that handling large scale production of biological agents under the Biological Agents and Toxins Act.

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2. Requirements

Requirements in applying for large scale production facility will depend on the schedule of the agent involved.

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

 

 

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3. Procedure in Applying for Large Scale Production Facility

Application to register as "Large Scale Production Facility" is done online and the following documents have to be submitted together with the application:

  1. First Schedule Part I biological agents
    1. Proof that the facility is a certified facility
    2. Proof that the facility has been granted a prior approval to possess the agent
    3. Proof that approval for large scale production of the agent has been granted
    4. Other supporting documents that the MOH deemed necessary in the application.
  2. First Schedule Part II biological agents
    1. Proof that the facility is a certified facility
    2. Proof that the facility is gazetted as a protected place under the Protected Areas and Protected Places Act
    3. Proof that the facility has been granted a prior approval to possess the agent
    4. Proof that approval for large scale production of the agent has been granted
    5. Other supporting documents that the MOH deemed necessary in the application.
  3. Third Schedule biological agents
    1. Proof that approval for large scale production of the agent has been granted
    2. Other supporting documents that the MOH deemed necessary in the application.

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4. Register as a Large Scale Production Facility

Once the facility has been granted an "approval for large scale production", the facility must then register his facility online as a large scale production facility.

You may click here to register as a "Large Scale Production Facility".

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5. FAQ

The FAQ's on the homepage of the biosafety website provide answers to commonly asked questions on biosafety.

Click here to go to the FAQ - Large Scale Production.

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