Registration for uncertified facility

1. Requirements for Registration as Uncertified Facility

  1. A written in-principle approval to possess and work with the First Schedule bioliogical agent granted by the Ministry of Health. 
  2. The facility must be gazetted as a protected place under the protected Areas and Protected Places Act if handling First Schedule Part II biological agent or Fifth Schedule toxins.
  3. The facility must have an Biosafety Committee (BC) composed of the members as stipulated in the 6th schedule of the Biological Agents and Toxins Act (BATA).
  4. All members of the facility shall comply with the duties and responsibilities stipulated in Part V of the BATA.

2. Documents Needed for Registration as Uncertified Facility

  1. The written in-principle approval from the Ministry of Health (for the possession of First Schedule biological agents).
  2. Order on gazetting (for protected places) for facilities handling First Schedule Part II biological agent and Fifth Schedule toxins.
  3. List of the Biosafety Committee of the facility which should conform to the members as stipulated in Sixth Schedule of the Biological Agents and Toxins Act.
  4. Training certificate of the biosafety coordinator.  
  5. List of personnel working in the facility (for facilities gazetted as protected place, the personnel must be vetted and cleared by the Ministry of Home Affairs).
  6. Other documents that the Ministry of Health deemed relevant to the application.

3. Validity of Registration for Uncertified Facility

The validity of the registration of an uncertified facility with the Ministry of Health is usually 3 years but, the Ministry of Health on their own discretion, at any time, may revoke or suspend the registration.

4. Register as Uncertified Facility

Uncertified facilities are facilties that are not certified as defined in the Biological Agents and Toxins Act but who has met the requirements of the Ministry to possess and work with First, Second and Fifth Schedule biological agents and toxins.

Click here to register as Uncertified Facility.

5. FAQ

The FAQs on the homepage of the biosafety website provide answers to commonly asked questions on biosafety.