Approval for Large Scale Production


1. 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.

2. Scope / Covers

Large scale production of Schedule 2 biological agents is prohibited.

Approval for large scale production is required for First and Third Schedule biological agents.

3. Requirements

Requirements in applying for an "Approval for Large Scale Production" will depend on the schedule of the agent involved.

 

ScheduleRequirements
PossessionCertified facilityProtected Place
First Schedule Part IYesYesNo
First SchedulePart IIYesYesYes
Third ScheduleNoNoNo

4. Procedure

Pre-requisite:
The facility must be registered with the Ministry of Health.

  1. The documents to be submitted to the Ministry of Health will depend on which schedule the biological agent concerned is classified.
    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. Formal letter of application for large scale production may be required
      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. Formal letter of application for large scale production may be required
      5. Other supporting documents that the MOH deemed necessary in the application.
    3. Third Schedule biological agents
      1. Formal letter of application for large scale production may be required
      2. Other supporting documents that the MOH deemed necessary in the application.
  2. An online application should also be made via the biosafety website e-services.

5. Fees

Currently, the Ministry of Health does not charge any fees for the application for large scale production of First and Third Schedule biological agents.

6. Processing Time

The processing time for an application for large scale production will depend on the accuracy of the data in the application and the completeness of the supporting documents which may be necessary in the processing of the application.

An application for large scale production may be approved within 2 working days provided that all the criteria and/or requirements for the application for large sscle production has been satisfied. The validity of an approval for large scale production will be tied to the validity of the registration of the facility. However, the Ministry of Health may, at anytime, has the discretion to revoke the approval given.

7. Apply for Large Scale Production

Facilities who are interested in large scale production of First and Third Schedule biological agents should apply online.

You may click here to apply for "Large Scale Production".

8. 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.

17 Sep 2018