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Biosafety

Special Approval to Handle

Find out more about the requirements for a special approval to handle under the Biological Agents and Toxins Act.

Last updated 22 April 2026

General

Special approval to handle is defined as an approval granted by the Ministry of Health (MOH) to an operator, to use a Second Schedule biological agent.

Scope or coverage

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

Requirements

Requirements for the application of a special approval to handle:

  1. The facility is registered with the MOH as a certified facility and a protected place

  2. The applicant is required to provide justifications of the following:

    • the use of the Second Schedule biological agent is necessary for the public interest

    • Adequate measures have been put in place to contain the risks to public health and security posed by the Second Schedule biological agent

  3. Any other documents or conditions that the Ministry of Health may deem necessary for the application

Applications

The following documents must be submitted to the MOH:

  1. Formal application to justify the need for using 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 Infrastructure Protection Act and meet all the Physical Security Working Group requirements

  4. Any other supporting documents that the MOH may deem necessary for the application.

Submit your application for a special approval to handle via the HALP-Biosafety portal.

Fees

Currently, the MOH does not charge any fees for the application or processing of an application for special approval to handle Second Schedule biological agent.

However, compliance verification services (e.g. facility certification/audit) provided by third party certifiers/auditors (e.g. Ministry of Health-Approved Facility Certifying Body, MOH-AFCB) will be chargeable.

Processing time

The processing time for an application for special approval to handle will depend on the accuracy and completeness of the information and supporting documents submitted in the application.

Processing time can take up to 3 months, even 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 and the project. 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.

Other information relevant to special approval to handle

  1. Certified Facility

  2. Approval to Possess