Human and zoonotic pathogens, toxins and inactivated biological agents
- Document symbol
- G/LIC/N/3/SGP/20
- Original language
- English
- Published on
- 16/10/2024
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
The Singapore Ministry of Health (MOH) regulates the import and transhipment of human pathogens, selected microbial toxins and inactivated (higher risk group) biological agents. MOH and the Animal and Veterinary Service (AVS) jointly regulate the import and transhipment of zoonotic pathogens.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Import permits are required for the importation of biological agents and selected microbial toxins, which are capable of causing death, disease or other biological malfunction in a human. The requirement for import permit is also applicable to any material (e.g. clinical samples, biological specimens, environmental samples and proficiency test samples) that are known to contain the biological agents and selected microbial toxins. MOH also controls the importation of inactivated (higher risk group) biological agents.
The list of biological agents and selected microbial toxins requiring import permits is categorised according to their risk profile under the Biological Agents and Toxins Act (BATA) First to Fourth Schedule for biological agents and Fifth Schedule for selected microbial toxins.
Do note that the list is non-exhaustive, and stakeholders are advised to consult MOH on import requirements for biological agents/items not on the list, prior to the importation.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to products originating in and coming from all countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
Singapore's import requirements for the biological agents and microbial toxins regulated under the BATA are intended to safeguard national safety and security in relation to the biological agents and toxins.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The import permit requirement for the biological agents and toxins is stipulated under the BATA**,** which are statutorily required and published in government gazettes. While the administration of the permit requirements is undertaken by MOH, the designation of products to be controlled and the abolishment of such control system require legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
MOH advises importers to submit applications for import permits at least five working days before the item is scheduled to arrive in Singapore. An import permit is usually processed within four working days provided all the criteria/requirements for the application has been satisfied.
Q7.b. Can a licence be granted immediately on request?
An import permit can be granted immediately on request if all the criteria/requirements for the application have been satisfied.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Import permit applications and its associated requirements can be made throughout the year.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Import permit for a microbial toxin, inactivated biological agent or solely human pathogen, is effected by a single administrative body (i.e. MOH) and the importer does not have to approach more than one administrative body. However, as MOH and AVS jointly control zoonotic pathogens, the import permit/licence for zoonotic pathogens may require approval from both MOH and AVS.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
An application for an import permit is granted if all stipulated criteria are met. MOH will provide the reason(s) in the event an import permit application is rejected.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
Applicants must be registered with MOH and be granted an approval to possess the respective biological agent/toxin, prior to the application and granting of an import permit for BATA First Schedule biological agents, Second Schedule biological agents, and Fifth Schedule toxins. Conditions of the approval are available on the biosafety website (http://www.moh.gov.sg/biosafety/home).
Import permit for BATA Fourth Schedule biological agents does not require additional prior approvals.
A valid TradeNet account is required to access the system to submit the application for import permit. The information related to the fees charged by TradeNet can be found at:
(https://www.tradenet.gov.sg/infrastructure/ora/rel1_0/info/plan/TradeNet_Fee_Details_7Nov2022.pdf)
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
Import permit applications are made on TradeNet. An inward declaration is required and must accurately state numerous information such as the description and quantities of each consignment, particulars of importer and company and company registration number. Additional documents such as shipping documents (i.e. airway bills, house airway bills, commercial invoice) may also be required. For inactivated biological agents, evidential documentation of inactivation verification must also be submitted.
Q11. What documents are required upon actual importation?
Importers are required to produce the import permit granted for the biological agents/toxins for the release from Singapore Customs.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
MOH does not charge any import permit fees. The information related to the fees charged by TradeNet can be found at: (https://www.tradenet.gov.sg/infrastructure/ora/rel1_0/info/plan/TradeNet_Fee_Details_7Nov2022.pdf)
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
MOH does not require any deposit or advance payment requirements associated with the issuance of import permits. The information related to the fees charged by TradeNet can be found at: (https://www.tradenet.gov.sg/infrastructure/ora/rel1_0/info/plan/TradeNet_Fee_Details_7Nov2022.pdf)
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Import permits are valid for up to two weeks following issuance. Validity of issued import permits are extendable. Extension requests are made on Tradenet and processed by Singapore Customs.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilisation of permit or a portion of it.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Permits are non-transferable.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
Any other conditions (if applicable) may be advised on a case-by-case basis and will be listed in the import permit issued.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
As mentioned under Question/Paragraph 9.