Basic information
Outline of the system
Therapeutic products, medical devices, Chinese proprietary medicines and oral dental gum are subject to licensing / approval requirements of the Health Science Authority (HSA) of Singapore before an import licence / permit can issued for their entry into Singapore.
Product coverage
The products subject to HSA’s import licensing procedures are listed in the table below.
|
Product |
Laws/Regulations |
|---|---|
|
Chinese proprietary medicines |
Medicines Act and its Regulations |
|
Clinical research materials |
Health Products (Clinical Research Materials) Regulations |
|
Clinical research materials containing psychotropic substances |
Health Products (Clinical Research Materials) Regulations |
|
Medical Devices |
Heath Products (Medical Devices) Regulations |
|
Therapeutic products |
Health Products (Therapeutic Products) Regulations |
|
Substances specified in the Poisons Act |
Poisons Act and its Rules |
|
Oral Dental Gums
|
|
|
Cell, Tissue and Gene Therapy Products |
|
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
All local importers, wholesalers, manufacturers and assemblers of CPM will be licensed. Requirements of licensing include submission of company details, details of CPM handled by company and various certificates to ascertain the safety and quality of the CPM as well as manufacturing standards. All local premises will be inspected prior to licensing and upon renewal of licences.
Products under restriction as to the quantity or value of imports
The licensing requirements are maintained for health and safety reasons. They are not intended to restrict the quantity or value of imports.
Questions for products under restriction as to the quantity or value of imports
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 section 5. Controlled drugs and controlled equipment, matierlas or substances used for the manufacturing of controlled drugs.
The system applies to products originating from which country?
HSA’s licensing requirements apply to products originating in and coming from all countries.
Expected duration of licensing procedure
There is no end date to the licensing system as there is an ongoing need to ensure the following:
- CPM sold in Singapore are safe and of good quality;
- CPM are labelled according to requirements; and
- efficient withdrawal from sale of CPM when such an action is deemed necessary.
Legal requirements
Is the licensing statutorily required?
The laws, regulations and/or administrative orders under which the licensing requirements are maintained are listed in our response to Question 2. 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 HSA, 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 HSA, 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?
What persons or firms are eligible to apply for a licence?
Generally, all persons, registered firms and institutions are eligible to apply for import licensing / approval. The licensee must appoint a registered pharmacist to be the responsible person when applying for:
• a Form A Poisons Licence, for dealing in Active Pharmaceutical Ingredients (API) that are intended for local clinical use.
• an importer's licence for therapeutic products if the company is dealing with:
o pharmacy-only medicines (P-only);
o prescription-only medicines (POM) for local supply;
o controlled drugs that are in the form of therapeutic products; and
o unregistered therapeutic products for patients’ use.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Chinese Proprietary Medicine Unit, Pharmaceutical Department, Ministry of Health
Address
2 Jalan Bukit Merah, Singapore 169547
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Health Science Authority (HSA)
Documentation requirements
What information is required in applications?
The following information is required in applications for import permits: 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 CTGTP which is exempted from registration) and tobacco products 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) do not require a product registration.
For the import of poisons and psychotropic substances, the following information is also required:
• A valid Form A poison licence number or a valid importer's licence for therapeutic products; and
• A valid psychotropic substance import authorisation number or a valid approval to import therapeutic products containing psychotropic substances.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Applications should be made in advance of arrival of the goods.
Are there any limitations as to the period of the year during which application for licence can 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.
Issuing the license
Can a licence be granted immediately on request?
Processing time will be required as per the application type. Please refer to 29.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Importer’s license will be issued within 10 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.
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 or clnical research materials containing controlled drugs, HSA licensing procedures is described in Question/Paragraph 7 of the Controlled Drugs section 8 above.
Which administrative body is responsible for approving application of licences?
Consideration of importer’s licence is effected by a single administrative body.
Must the applications be passed on to other organs for visa, note or approval?
The importer does not have to approach more than one administrative body.
Are there any other conditions attached to the issue of a licence?
Except for the quantitative import per consignment for controlled drugs and psychotropic substances, importers of therapeutic products, poisons and Chinese proprietary medicines and cell, tissue and gene therapy products are not subject to any quantitative restrictions.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Licensing fees are required.
What is the amount of the fee or charge?
The various fees related to registration of products / devices and importer’s licenses are published on HSA’s website.
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 licence is usually granted if it meets the stipulated criteria.
Are the reasons for any refusal given to applicants?
In the event of a refusal for issuance, the reason(s) is/are generally provided.
Have applicants a right of appeal in the event of refusal to issue a licence?
Applicant who is refused a licence may appeal against the decision in writing for reconsideration.
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?
There are no limitations on the period of the year during which applications for licence and/or importation may be made.
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.
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.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The importer licenses for therapeutic products, medical devices, Chinese proprietary medicines, and oral dental gum and cell, tissue and gene therapy products are issued with one-year validity.
For 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.
For therapeutic products, HSA offers annual and consignment licences.
The validity of these licences may be extended by renewal.
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 not transferable without the approval in writing from the relevant authority.
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.