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This application is a service of the Singapore Government.

Health Sciences Authority

Controlled Drugs/ Psychotropic and Restricted Substances

Regulatory Guidelines and Standards

1961 United Nations Single Convention on Narcotic Drugs

Singapore is a party to the 1961 United Nations Single Convention on Narcotic Drugs. HSA is the competent authority for Singapore with respect to the granting of import and export licences for narcotic drugs (controlled in Singapore under the Misuse of Drugs Act), and the submission of adhoc, quarterly and annual statistical reports to International Narcotics Control Board (INCB), based in Vienna, on the importation, exportation and other legitimate international dealings of narcotic drugs in and out of Singapore.

1971 United Nations Convention on Psychotropic Substances

Singapore is a party to the 1971 United Nations Convention on Psychotropic Substances. HSA is the competent authority for Singapore with respect to the granting of approval to import and export of internationally-controlled Psychotropic Substances (e.g. benzodiazepines, central nervous system stimulants, etc), and the submission of adhoc, quarterly and annual statistical reports to the International Narcotics Control Board (INCB), based in Vienna, on the importation, exportation and other legitimate international dealings of Psychotropic Substances in and out of Singapore.

Controlled Drugs (CDs)

Controlled Drugs (CDs) are substances specified in the First Schedule to the Misuse of Drugs Act. All narcotic drugs under the 1961 United Nations Single Convention on Narcotic Drugs are classified as Controlled Drugs under the Misuse of Drugs Act. Some of the Psychotropic Substances under the 1971 United Nations Convention on Psychotropic Substances are also classified as Controlled Drugs under the Misuse of Drugs Act.

A company/organisation/institution is required to apply for import or export licence from the Health Products Regulation Group (HPRG), Health Sciences Authority (HSA) to import or export any consignment of Controlled Drugs in or out of Singapore for legitimate and authorised use of Controlled Drugs. The import / export licence enables the applicant to import / export a Controlled Drug listed in Second to Fourth Schedules to the Misuse of Drugs Regulations into Singapore. The Controlled Drugs can come in the form of raw material or ready-made preparation.

The company/organisation/institution should authorise a registered pharmacist to apply for the licence. The applicant should hold a valid poisons licence. The purposes of the import or export of Controlled Drugs would be assessed before the licences can be processed and issued. The licences are issued on a per consignment basis and the consignment should be imported or exported out of Singapore within 6 months from the date that the licences are issued. The applicant should also be the one who has overall responsibility for the import / export, use, storage, security and sale and supply of Controlled Drugs.

Companies involved in supply, distribution and wholesale activities of Controlled Drugs is required to apply to Health Products Regulation Group (HPRG), Health Sciences Authority (HSA) for licences to sell Controlled Drugs by way of wholesale. The Controlled Drug Wholesale Licence is issued to a registered pharmacist authorised by the company. The licence holder is responsible for the wholesale activities of the Controlled Drugs as listed in the licence.

In addition, a licence is required for a company to manufacture preparations containing Controlled Drugs. For more information on Manufacturer's licence for Controlled Drugs, please read HSA website on Licence to manufacture Controlled Drugs under Audit and Licensing of Manufacturers.
Proper documentation, including a Controlled drug register, to account for all the quantities of Controlled Drugs must be kept by the licensed persons in the company. The company/organisation/institution would be subject to routine site inspection.

Psychotropic Substances (PSY) and Restricted Substances (RS)

Psychotropic Substances (PSY) are substances specified in the Medicines (Export Licence For Psychotropic Substances) Regulations.
Restricted Substances (RS) are substances which require an import authorisation issued by the importing authority to authorise the importation. These substances are more stringently controlled overseas, but are controlled as poisons locally. The substances should be neither Controlled Drugs nor Psychotropic Substances.

A company/organisation/institution is required to apply for import authorisation or export licence from the Health Products Regulation Group (HPRG), Health Sciences Authority (HSA) to import or export any consignment of Psychotropic Substance or Restricted Substance in or out of Singapore for legitimate and authorised use of these substances. The import authorisation enables the applicant to import a Psychotropic Substance/ restricted substance while the export licence enables the applicant to export a Psychotropic Substance listed in the Medicines (Export Licence For Psychotropic Substances) Regulations. The Psychotropic Substances or Restricted Substances can come in the form of raw material or ready-made preparation.

The company/organisation/institution should authorise a registered pharmacist to apply for the import authorisation / export licence. The applicant should hold a valid poisons licence. The purposes of the import or export of Psychotropic Substances / Restricted Substances would be assessed before the import authorisations / export licences can be processed and issued. The import authorisations and  export licences are issued on a per consignment basis and the consignment should be imported or exported out of Singapore within 6 months from the date that the authorisation or licences are issued. The applicant should also be the one who has overall responsibility for the import / export, use, storage, security and sale and supply of Psychotropic Substances / Restricted Substances.

New Information Related to Implementation of the Health Products (Therapeutic Products) Regulations 2016 (to be effective from 1 November 2016) 

Import of Therapeutic Products containing Psychotropic Substances:

If your company is importing therapeutic products containing Psychotropic Substances, an Approval to Import Therapeutic Products containing Psychotropic Substances will be mandatory for importing each consignment of such products. Your company should also hold a Therapeutic Product Importer’s Licence valid for the import of these therapeutic products.

Export of Therapeutic Products containing Psychotropic Substances:

If your company is exporting therapeutic products containing Psychotropic Substances, an Approval to Export Therapeutic Products containing Psychotropic Substances will be mandatory for exporting each consignment of such products. Unless under exception in the law, your company should also hold a valid Therapeutic Product Wholesaler’s Licence.

The list of Psychotropic Substances is gazetted under the First Schedule of the Health Products (Therapeutic Products) Regulations 2016.

Certificate of Approval for Import of a Therapeutic Product:

Some countries may control certain substances more stringently and require specific documentary evidence of approval from the importing country’s authority before these substances can be exported. If your company is importing therapeutic products containing such substances, you may apply for a Certificate of Approval for Import of a Therapeutic Product. These therapeutic products should be registered in Singapore and not containing any Controlled Drugs or Psychotropic Substances. Your company should also hold a Therapeutic Product Importer’s Licence valid for the import of these therapeutic products.

Legislations on Controlled Drugs and Psychotropic Substances

The applicant should familiarise himself or herself with the following legislations:

  • The Misuse of Drugs Act
  • The Misuse of Drugs Regulations
  • Medicines Act
  • Medicines (Export Licence For Psychotropic Substances) Regulations
  • Health Products Act
  • Health Products (Therapeutic Products) Regulations 2016 (to be effective from 1 Nov 2016)

Printed copies of these legislations are available at the following:

Toppan Leefung Pte. Ltd. (Legal Publishing)
1 Kim Seng Promenade #18-01/06
Great World City East Tower
Singapore 237994

Tel No.: 6826 9691
Email: legalpub@toppanleefung.com 
Website: http://www.toppanleefung.com/Header_LegalPub.aspx