Import Licensing Notification Portal

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.

Therapeutic products, medical devices, Chinese proprietary medicines, oral dental gum, cell, tissue and gene therapy products; and active ingredients are subject to licensing/approval requirements of the Health Sciences Authority (HSA) of Singapore before an import licence/approval can be issued for their entry into Singapore.

Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.

The products subject to HSA's import licensing procedures are listed in the table below.

Product	Laws/Regulations
Therapeutic products	Health Products (Therapeutic Products) Regulations
Medical Devices	Heath Products (Medical Devices) Regulations
Chinese proprietary medicines	Medicines Act and its Regulations
Oral Dental Gums	· Health Products (Oral Dental Gums) Regulations · Regulation of Imports and Exports (Chewing Gum) Regulations
Cell, Tissue and Gene Therapy Products	Health Products (Cell, Tissue and Gene Therapy Products) Regulations
Clinical research materials	Health Products (Clinical Research Materials) Regulations
Substances specified in the Poisons Act	Poisons Act and its Rules
Psychotropic Substances	· Health Products (Therapeutic Products) Regulations · Health Products (Clinical Research Materials) Regulations · Health Products (Active Ingredients) Regulations · Medicines Act and its regulations
Active Ingredients	Health Products (Active Ingredients) Regulations

Q3. The system applies to goods originating in and coming from which countries?

HSA's licensing requirements apply 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?

The licensing requirements are maintained for health and safety reasons. They are not intended to restrict the quantity or value of imports.

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 laws, regulations and/or administrative orders under which the licensing requirements are maintained are listed in Question/Paragraph 2. The licensing requirements are statutorily required and published in government gazettes. While the administration of the licensing requirements is undertaken by HSA, the designation of products to be subjected to licensing and the abolishment of any licensing system require legislative approval.

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):

Singapore abides by the International Narcotics Control Board's (INCB) allocation of quotas for narcotic drugs and psychotropic substances controlled under the UN Single Convention on Narcotic Drugs 1961 as amended by the 1972 Protocol and UN Convention on Psychotropic Substances 1971. Therapeutic products or clinical research materials that contain controlled drugs or psychotropic substances are also subject to INCB's quota system. Such therapeutic products or clinical research materials are regulated by HSA through licensing procedures similar to that of controlled drugs, as described in our response to Section 8 above.

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)?

Applications should be made in advance of arrival of the goods.

Importer's licence will be issued within ten working days from the date of completion of the necessary audit (excluding any time incurred by the applicant's request for clarifications and additional information). For Oral Dental Gum, the issuance of the relevant importer's licence does not require an audit.

Import of Active Ingredients for use in clinical research/clinical trials do not require an import licence and can be carried out after an Active Ingredient Notification has been made to HSA.

Importing of clinical research materials for use in clinical trials does not require an import licence and can be carried out after a Clinical Research Material Notification (CRM-N) has been made to HSA.

For therapeutic products, active ingredients or clinical research materials containing controlled drugs, HSA licensing procedures is described in Paragraph 7 of the Controlled Drugs section 8 above.

Approval to import a psychotropic substance will be issued within 20 working days if all relevant supporting documents are provided. Application requirements can be found on HSA website.

Q7.b. Can a licence be granted immediately on request?

Processing time will be required as per the application type. Please refer to 7(a).

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.

There are no limitations on the period of the year during which applications for licence and/or importation may be made.

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?

Consideration of importer's licence is effected by a single administrative body (i.e. HSA). The importer does not have to approach more than one administrative body.

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 licence is usually granted if it meets the stipulated criteria. In the event of a refusal for issuance, the reason(s) is/are generally provided. Applicant who is refused a licence may appeal against the decision in writing for reconsideration.

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?

Generally, all persons, registered firms and institutions are eligible to apply for import licence/approval. The licensee must appoint a registered pharmacist to be the responsible person when applying for:

An importer's licence for Active Ingredients imported for the manufacture of therapeutic products, cell, tissue and gene therapy products or medical devices intended for local clinical use.
An importer's licence for therapeutic products if the company is dealing with:
- Pharmacy-only medicines (P-only);
- Prescription-only medicines (POM) for local supply;
- Controlled drugs that are in the form of therapeutic products;
- Therapeutic Products containing psychotropic substances; and
- Unregistered therapeutic products for patients' use.

Importers of therapeutic products, Chinese proprietary medicines, cell, tissue and gene therapy products and active ingredients intended for local clinical use are required to comply with HSA's Good Distribution Practice (GDP) requirements to ensure that products are handled, stored and distributed in an appropriate manner to assure their quality and integrity throughout the supply chain. Issuance of importer's licence is subject to the satisfactory close-out of GDP audit.

Importers of medical devices of risk categories other than Class A medical devices are required to be certified to ISO 13485 or Good Distribution Practice for Medical Devices (GDPMDS) as a pre-requisite for licence application. Certification to GDPMDS is performed by third party certification bodies that are accredited by the Singapore Accreditation Council.

Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?

The following information is required in applications for importer's licence: particulars of importer, company registration certificate issued by the Singapore Registry of Companies and Businesses, product description, product quantity, mode of transport, port of shipment/transport, product brand/serial number/model/make and country of origin, applicant details, warehouse details and responsible person. In addition, importers of the products listed under question 2 are required to apply and obtain an importer's licence from HSA, whose requirements can be found on its website.

Therapeutic products, medical devices (unless it is a Class A medical device which is exempted from registration), Chinese proprietary medicines, oral dental gums, cell tissue and gene therapy products (unless it is a Class 1 Cell, Tissue and Gene Therapy Products (CTGTP) which is exempted from registration) are required to be registered with HSA prior to importation.

Therapeutic products, medical devices and Class 2 CTGTPs imported through a special authorisation/approval route from HSA (e.g. for re-exports, supply to ships and/or aircraft, clinical trials, non-clinical purposes and personal use) and Active Ingredients do not require a registration with HSA.

Q11. What documents are required upon actual importation?

Upon actual importation, importers are required to make an Inward Declaration showing the correct description and quantities of each consignment made electronically through TradeNet. Shipping documents such as the Bill of Lading/Airway Bill and invoice are also required.

Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?

The various fees related to registration of products/devices and importer's licences are published on HSA's website.

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.

There are no deposit or advance payment requirements associated with the issuance of licences.

Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?

The importer licences for therapeutic products, medical devices, Chinese proprietary medicines, oral dental gum, cell, tissue and gene therapy products, and active ingredients are issued with one-year validity. The validity of the licences may be extended by renewal.

HSA also offers consignment importer's licences for the following products:

Therapeutic products
- Importing therapeutic products solely for supply to ships/aircraft leaving Singapore.
- Importing therapeutic products solely for export only.
- Importing therapeutic products for non-clinical use.
Cell, tissue and gene therapy products
- Import of cell, tissue and gene therapy products solely for export, scientific education, research and development or non-clinical use.

For consignment importer's licences and the import of controlled drugs and psychotropic substances, the licence, approval or authorisation is issued on a per consignment basis and is valid for 6 months from the date of issuance.

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 licence or a portion of it.

Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?

Licences are not transferable without the approval in writing from the relevant authority.

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?

Except for the quantitative import per consignment for controlled drugs and psychotropic substances, importers of therapeutic products, medical devices, poisons and Chinese proprietary medicines, oral dental gums, cell, tissue and gene therapy products, and active ingredients are not subject to any quantitative restrictions.

Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

There are no other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation.

Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?

N/A

Therapeutic products, medical devices, Chinese proprietary medicines, oral dental gums, and cell, tissue and gene therapy products and active ingredients

Outline of Systems

Purposes and Coverage of Licensing