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Health Sciences Authority

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 on 31 October 2026

General

Special Approval to Handle refers to approval granted by the Health Sciences Authority (HSA) to a Facility Operator for the use of Second Schedule biological agents.

Scope

Only Second Schedule biological agents require Special Approval to Handle.

  1. Table of Controls for the Scheduled Biological Agents and Toxins. (opens in new tab)

  2. List of Biological Agents and Toxins. (opens in new tab)

Requirements

Facilities applying for Special Approval to Handle must meet the following requirements:

  1. Be registered with the HSA as a Certified Facility and a Protected Place.

  2. Provide sound justifications demonstrating -

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

    • Adequate measures are in place to mitigate risks to public health and security.

  3. Submit any additional documents or fulfil any additional conditions as required by HSA.

Application

Facilities meeting the above requirements can apply via the Healthcare Application and Licensing Portal-Biosafety Module (HALP-BS (opens in new tab)).  

Fees

Currently, HSA does not charge fees for applications for Special Approval to Handle Second Schedule biological agents.

Processing Time

Processing time depends on the accuracy and completeness of the submission. Applications may take up to 3 months, even if all the requirements and/or conditions are met.

Validity

Approval validity is tied to the registration validity of the facility and project. HSA may revoke or suspend approval at its discretion.

Frequently Asked Questions

Find answers to common queries on the FAQ page.

Related Information

  1. Certified Facility

  2. Protected Place

  3. Approval to Possess

  4. Notification