1. General
Certification process is done by an independent facility certifier registered with the Ministry of Health, whose certification criteria is based on the MOH checklist which was derived from the recommendations of the World Health Organization (WHO) and incorporating the local requirements from the Biological Agents and Toxins Act (BATA).
2. Biological Agents Requiring a Certified Facility
Interested parties who would like to possess or work with Schedule 1 Part 1 biological agents, Schedule 1 Part 2 biological agents and Schedule 2 biological agents must have their facilities certified.
3. MOH-Approved Facility Certifier (MOH-AFC)
The certifiers included in this list are approved by the Ministry of Health (MOH) to have the necessary experience and are credible in certifying biosafety level 3 containment facilities.
4. MOH Laboratory Certification Checklist
The MOH Laboratory Certification Checklist was devised based on the 3rd edition of the WHO Laboratory Biosafety Manual Certification Checklist and the local requirements based on the Biological Agents and Toxins Act (BATA).
5. Procedure for Certification
- The facility must get the services of an MOH-Approved Facility Certifier (MOH-AFC) to certify their facility.
- The facility operator shall inform MOH of the certification schedule, at least 1 month prior to the certification date.
- If the certification of the facility is successful, the facility should be issued with certificate and a full report of the certification of the facility.
Facilities must register with MOH if they intend to possess, store or work with Schedule 1 Part I and II and Schedule 2 biological agents or with biological agents that are not in the "List of Biological Agents and Toxins" but are evaluated by the MOH as may be classified similarly as the above mentioned schedules.
6. Registration with MOH
Facilities who are interested to possess or work with Schedule 1 and Schedule 2 biological agents are required to register with MOH.
You may click here to register now.
7. Validity of Certification
The validity of the certification for a certified facility is 1 year except in cases wherein the facility certifier may issue a temporary certificate with a shorter validity period, either due to non-compliance in the requirements or a problem that require the facility operator to fix or rectify within a specified period of time.
The temporary certificate is issued on the condition that the issues identified will not compromise the safe functioning of the facility. The issuance of temporary certificate is also subject to MOH's approval.
The facility operator is also required to obtain an approval from the facility certifier and MOH if he intends to carry out any design or structural change to the facility, as this may affect the validity of the certification of the facility.