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 into 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.
Applicants applying for licences to import or export controlled drugs should hold a valid Form A Poisons Licence, Therapeutic Product Importer's Licence or Therapeutic Product Wholesaler's Licence as appropriate. 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 are 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)
Psychotropic Substances (PSY) are substances specified in the Medicines (Export Licence For Psychotropic Substances) Regulations or First Schedule of the Health Products (Therapeutic Products) Regulations 2016, and their imports and exports are subject to the necessary approvals or licences granted by HSA
Importing Psychotropic Substances:
For companies importing therapeutic products containing psychotropic substances, an Approval to Import Therapeutic Products containing Psychotropic Substances is mandatory. Companies importing psychotropic substances in other forms such as laboratory reagents, test kits, active pharmaceutical ingredients (API) or products for veterinary use, may apply for an Import Authorisation for Psychotropic Substances.
Exporting Psychotropic Substances:
Exports of therapeutic products containing psychotropic substances require an Approval to Export Therapeutic Products Containing Psychotropic Substances. For exports of psychotropic substances in other forms, companies should apply for an Export Licence for Psychotropic Substances.
Companies importing or exporting psychotropic substances should also hold a valid Form A Poisons Licence, Therapeutic Product Importer Licence or Therapeutic Products Wholesaler’s Licence as appropriate. Each psychotropic substance import or export licence, approval or authorisation is valid for six months and for a single consignment only.
Import of Other Substances
Certain substances, while not controlled as CDs or PSY in Singapore, may be regulated more stringently in other countries. Such countries may require specific documentary evidence of approval from the importing country’s authority before allowing the export. Companies importing therapeutic products containing such substances may apply for a Certificate of Approval for Import of a Therapeutic Product. Unless specific approvals are obtained, these therapeutic products should be registered in Singapore. The company should also hold a Therapeutic Product Importer’s Licence valid for the import of these products.
Companies importing such substances in other forms such as laboratory reagents, test kits, active pharmaceutical ingredients (API) or products for veterinary use, may apply for an Import Authorisation for Restricted Substances. The company should also hold a valid Form A Poisons Licence.
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 (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