Basic information
Outline of the system
The Singapore Ministry of Health (MOH) regulates the import and transhipment of human pathogens, selected toxins and inactivated biological agents. MOH and the Animal Veterinary Services (AVS) jointly regulate the import and transhipment of zoonotic pathogens.
Product coverage
Import permits are required for the importation of biological agents and selected 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 toxins. MOH also controls the importation of selected inactivated (Higher risk group) biological agents.
The list of biological agents and selected 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 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.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
Singapore's import requirements for the biological agents and toxins regulated under the BATA are intended to safeguard national safety and security in relation to the biological agents and toxins.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
The system applies to products originating from which country?
The system applies to products originating in and coming from all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The import permit requirement for the biological agents and toxins is stipulated under the BATA. The licensing requirements are statutorily required and published in government gazettes.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
While the administration of the licensing requirements is undertaken by MOH, the designation of products to be subjected to licensing and the abolishment of any licensing system require legislative approval.
Is it possible for the government to abolish the system without legislative approval?
While the administration of the licensing requirements is undertaken by MOH, the designation of products to be subjected to licensing and the abolishment of any licensing system require legislative approval.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
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.
What persons or firms are eligible to apply for a licence?
Is there a registration fee?
The registration fee can be found on the following TradeNet weblink:
(https://www.tradenet.gov.sg/infrastructure/ora/rel1_0/info/plan/TradeNet...)
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Singapore Ministry of Health (MOH)
Documentation requirements
What information is required in applications?
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.
What documents is the importer required to supply with the application?
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.
Window of submission of an application
How far in advance of importation must application for a licence be made?
MOH advises importers to submit applications for import permits at least 5 working days before the item is scheduled to arrive in Singapore.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Import permit applications and its associated requirements can be made throughout the year.
Issuing the license
Can a licence be granted immediately on request?
A licence will be granted immediately on request if all the criteria/requirements for the application have been satisfied.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
An import permit is usually processed within 2 working days provided all the criteria / requirements for the application has been satisfied.
Which administrative body is responsible for approving application of licences?
Import licence for a 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.
Must the applications be passed on to other organs for visa, note or approval?
However, as MOH and AVS jointly control zoonotic pathogens, the import permit/licence for zoonotic pathogens may require approval from both MOH and AVS.
Are there any other conditions attached to the issue of a licence?
Any other conditions (if applicable) may be advised on a case-by-case basis and will be listed in the import permit issued.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
MOH does not charge any licensing fees.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
There are no deposit or advance payment requirements associated with the issuance of licences.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
An application for an import permit is granted if all stipulated criteria are met.
Are the reasons for any refusal given to applicants?
MOH will provide the reason(s) in the event an import permit application is rejected.
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
Import permit applications and its associated requirements can be made throughout the year.
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.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
As mentioned under question 12.
Conditions of licensing
What is the period of validity of a licence? Can the validity 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.
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 licence or a portion of it.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are non-transferable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.