Uncertified Facility

General

An uncertified facility is typically a Biosafety Level 2 (BSL2) facility that has implemented enhanced biorisk (biosafety and biosecurity) management measures and is approved by Ministry of Health (MOH) to handle Fifth Schedule toxin or low risk activities associated with materials positive for First Schedule biological agent.

Requirements for registration as an uncertified facility

1. The facility must have an Biosafety Committee (BC) composed of the members as stipulated in the Sixth Schedule of the Biological Agents and Toxins Act (BATA).

2. The facility must put in place safety and security requirements which are commensurate with the risks posed by the scheduled biological agent and toxin, and the activities undertaken. These shall be supported by a compliance verification (inspection or audit) report.

3. All members of the facility shall comply with the duties and responsibilities stipulated in Part 5 of the BATA.

4. Additional requirements for facilities planning to handle First Schedule Part 2 biological agent and/or Fifth Schedule toxin include:

   1. the facility must be gazetted as a protected place under the Infrastructure Protection Act and meet the requirements stipulated in the Physical Security Workgroup checklist.

   2. personnel working in the facility must be security vetted by the relevant authority.

Information and/or documents needed for registration as an uncertified facility

Please refer to FAQ – Uncertified Facility.

Register as an uncertified facility

Submit your application via the HALP-Biosafety portal.

Fees

Currently, the MOH does not charge any fees for the registration of an uncertified facility.

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

Processing time

The processing time will depend on the accuracy and completeness of the information and supporting documents submitted for the application.

The application may take up to 30 working days to process, if and only if all the criteria and/or requirements for the application have been satisfied.

Validity of registration for uncertified facility

The validity of the registration of an uncertified facility with the MOH is usually 3 years. The MOH may at its discretion, revoke or suspend the registration at any time.

FAQ

Find answers to commonly asked questions on the FAQ page.

Other information relevant to uncertified facility

1. Biosafety Committee

2. Facility Operator

3. Approval to Possess

4. Approval to Large-scale Produce

5. Protected Place

6. Permit (Import/Transhipment)

7. Transportation

8. Notification Information