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Authorizations to import and export Restricted/Psychotropic Substances, Licence to import/export Controlled Drugs and Licence to sell Controlled Drugs by way of wholesale

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Regulatory Guidelines and Standards

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 import authorisations and export licences for 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.

Psychotropic Substances are substances specified in the Medicines (Export Licence For Psychotropic Substances) Regulations.

Restricted Substances are substances which require an import authorization issued by the importing authority to authorize 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.

The import authorisation enables a dealer to import a psychotropic substance / restricted substance while the export licence enables a dealer to export a psychotropic substance listed in the Medicines (Export Licence For Psychotropic Substances) Regulations. The psychotropic substances can come in the form of raw material or ready-made preparation.

The firm/company should authorise a registered pharmacist to apply for the import authorisation / export licence. The applicant should have a legitimate and authorised use of the psychotropic substance / restricted substance before the authorisation can be issued to them, and should hold a valid poisons licence.

In the case of an importation of psychotropic substances, the applicant should also be one who has overall responsibility for the import, use, storage and sale of the psychotropic substance / restricted substance.

An import authorisation may be issued for the import of a consignment of psychotropic substance or restricted substance into Singapore. An export licence is also required for the export of any consignment of psychotropic substance out of Singapore. The consignment of goods shall be imported or exported within 6 months from the date of the authorisation or licence is issued.

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 INCB, on the importation, exportation and other legitimate international dealings of narcotic drugs in and out of Singapore.

Controlled Drugs are substances specified in the First Schedule to the Misuse of Drugs Act.
The import / export licence enables a dealer 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 firm/company should authorise a registered pharmacist to apply for the licence. The applicant should also have a legitimate and authorized use of the controlled drug(s) before the licence can be issued to them, and should hold a valid poisons licence.

In the case of an importation of the controlled drugs, the applicant should also be the one who has overall responsibility for the import, use, storage and sale of the controlled drug.

A licence from the Health Products Regulation Group (HPRG), Health Sciences Authority (HSA) is required before any consignment of controlled drug (eg. morphine, pethidine, heroin) can be imported or exported out of Singapore. The licences are issued on consignment basis and the consignment should be imported or exported out of Singapore within 6 months from the date the licences are issued. In addition, licences are required to manufacture preparations containing Controlled Drugs and to sell Controlled Drugs by wholesale.

Licence to sell Controlled Drugs by way of wholesale is issued to pharmacists whose companies are involved in wholesale activities. The licence holder is responsible for the wholesale activities of the controlled drugs as listed in the licence.

The applicant should familiarise himself with the following legislations:

The Misuse of Drugs Act

The Misuse of Drugs Regulations

Medicines Act

Medicines (Export Licence for Psychotropic Substances) Regulations

Copies of these legislations are available at the following:

SNP Corporation Ltd (Legal Publishing)
1 Kim Seng Promenade #18-01/06
Great World City East Tower
Singapore 237994

Tel No.: 68269691
Email: lpcrsg@snpcorp.com  
Website: www.snpcorp.com/webshop


Last updated on 29 Sep 2008 17:53:21
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