Special Approval to Handle

1. General

It is defined as an approval granted by MOH to an operator, to use a second schedule biological agent.

2. Scope / Covers / List of Schedules

Only Second Schedule biological agents require "Special Approval to Handle" which is granted by the Ministry of Health.

  1. Table of Controls for the 5 Schedules
  2. List of Biological Agents and Toxins

3. Requirements

Requirements in applying for an import permit:

  1. Pre-requisites in applying for a special approval to handle will require the applicant to justify that:
    1. the second schedule biological agent is necessary in the public interest
    2. adequate measures has been put in place to contain the risks to public health and security posed by the Second Schedule biological agents. (Part III Division 3 Section 14) 
      1. Certified facility
      2. Protected Place
  2. Any other documents or conditions that the Ministry of Health deems necessary to the application.

4. Procedure

  1. The following documents must be submitted to the Ministry of Health:
    1. Formal letter of application to use the second schedule biological agent.
    2. Proof that the facility is a certified facility.
    3. Proof that the facility is gazetted as a protected place under the Protected Areas and Protected Places Act.
    4. 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 or processing of an application for special approval to handle Second Schedule biological agents.

6. Processing Time

The processing time for an application for special approval to handle 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 special approval to handle may be approved within 2 working days provided that all the criteria and/or requirements for the application for special approval to handle has been satisfied. The validity of special approval to handle 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 Special Approval to Handle

Facilities who are interested in working with Second Schedule biological agents should apply online.

You may click here to apply for "Special Approval to Handle".

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 - Special Approval to Handle.