NEW APPLICATION FOR A LICENCE TO IMPORT CONTROLLED DRUGS

1. The online form may take an average of 20 minutes to fill in. The time taken varies depending on the number and sizes of the file attachments, configurations of your computer and network system, internet performance etc. The recommended computer and network configurations are at http://www.hsa.gov.sg/publish/hsaportal/en/services/prism/sys_requirements.html. Please note that the time stated above excludes time taken for preparatory work in relation to filling the online form (e.g. scanning documents for file attachments). 2. You may need the following information/item(s) to fill the form: The registration confirmation issued by Registration of Society or Business profile (for ARCA Registered company) The list of diagnostic devices containing controlled drugs to be imported. This is only relevant for dealers importing diagnostic devices containing controlled drugs

3. For company who is applying a licence/certificate with HSA for the first time, you are required to register with CRIS. 4. The applicant will require a Singpass before you can login the system to retrieve the application form. A person who drafts an application on behalf of his/her company and is not a Singaporean Citizen, Permanent Resident or employment pass holder can apply for a HSA Pin to login to PRISM. The Singpass and HSA Pin login is necessary for authentication and authorization purposes. For more information on Singpass, please visit http://www.ecitizen.gov.sg/singpass/index.htm. For more information on HSA Pin, please visit http://www.hsa.gov.sg/publish/hsaportal/en/services/hsa_pin.html. 5. Mode of payment The mode of payment available is as follows Credit Card Debit Card FlexiPay GIRO Both FlexiPay and GIRO required pre-registration. The registration process will take around 3 to 4 weeks after the submission of the application form. More information on FlexiPay can be found at http://www.ecitizen.gov.sg/flexipay/index.htm. For GIRO registration, applicant will need to submit the GIRO application form by post to the HSA Finance department. The correspondence address can be found in the application form.

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Application Form Part One - Companys Particular These details should be automatically displayed for your confirmation. 1) Company Name 2) Company Business Address, Postal Code, Level and Unit number 3) Company Telephone/Fax number 4) Company/Business Registration number (ACRA Number) Applicant should also provide the billing address if it is different from the Company address. Part Two Applicant Particulars The section requires the applicant to furnish this information 1) Applicant Name 2) Applicant NRIC/Fin 3) Designation 4) Postal Code, Level and Unit number (The details of the Applicant Residential Address will be reflected automatically through the Postal Code retrieval function) 5) Contact Details like Telephone/Fax/Handphone/Pager number and E-mail address 6) Preference Contact mode (Please note that your preferred contact mode is the delivery mode of which you will receive the final notification of this application. During the course of this application, you will receive our input requests (i.e. queries), if any, via email if you have indicated your email address above, regardless of your selected preferred contact mode.) Part Three Wholesale / Poison Licence The section requires the applicant to furnish this information 1) CD Wholesale Dealers Licence No, if applicable. Importers who wish to resell or re-supply the controlled drugs imported will be required to hold a valid CD Wholesale Dealers Licence before the Licence to Import Controlled Drugs will be issued. The CD Wholesale Dealers Licence should be held by the applicant of the application for a Licence to Import Controlled Drugs 2) A valid Poisons Licence No. The Poisons Licence should be held by the applicant of the application for a Licence to Import Controlled Drugs Part Four Exporter Particulars The section requires the applicant to furnish this information 1) The name, address and contact details of the exporter of the consignment of controlled drugs. Please enter the address of the exporter at section 4.2.2 and the exporters country of residence at section 4.2.6. Information such as Province, State and City is not necessary if the details are given in section 4.2.2 2) Mode of importation of the consignment of controlled drugs 3) Proposed period of importation, which can be an estimation. You will just need to provide the month during which the consignment will be imported

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Part Five (A) Substances To Be Imported The section requires applicant to furnish this information 1) Brand/Name of substance to be imported. Please note that the name given for the substance to be imported will be reflected on the licence issued. You are recommended to use the same name in the corresponding application for the Export Authorisation to be issued by the National Regulatory Authority of the exporting country. Only one substance should be included in each application for a Licence to Import Controlled Drugs. The Licence is issued on a per consignment basis, and separate applications specifying the purpose of import (at section 5.3) should be submitted if a controlled drug is imported for both local consumption and re-export. If you intend to import diagnostic devices containing controlled drugs, please indicate Diagnostic Devices containing Controlled Drugs as the Name of substance required in section 5.1 and refer to paragraph (3) for more details 2) Total quantity of units to be import. For a substance that comes in unit doses, please give the total number of units you will be importing. Eg, for 500 boxes of ABC 5mg tablet 30s, the total quantity of units to be imported is 15000 tablets. Eg, for 500 bottles of XYZ Syrup 100ml, the total quantity of units to be imported is 500. If you are importing a controlled drug bulk material, please give the total weight of the material you are importing. Eg, for 25000g of Diphenoxylate HCl powder, the total quantity of units to be imported is 25000. 3) Diagnostic device. If you are importing diagnostic devices containing controlled drugs, please select Yes for section 5.2. You will be asked to attach the list of diagnostic devices you intend to import for the consignment as a supporting document. The list that you have attached will be appended as a Schedule to the licence issued. 4) Purpose of importation, which can either be import for local consumption, or import for reexportation to another country 5) Raw Material. Please select Yes for section 5.4 Raw Material if you are importing the bulk material form of a controlled drug (the Active Pharmaceutical Ingredient). This selection will determine the calculation of the total controlled drug in base you will be importing in the subsequent sections. 6) Present Stock available in the company, and the dosage form and presentation of the substance to be imported to be given if applicable. You can select the relevant details from the selection list provided 7) Add the substance by clicking on the Add Substance button. You will see the page refreshes, and the refreshed page will display the details of the substance you have added. To go to Part Five (b) Ingredient Details, you will have to click the checkbox next to the substance you wish to update, and click on Add/View/Update/Remove Ingredient(s). This will allow you to add the controlled drug active ingredient(s) for the substance you are importing. Part Five (B) Ingredient Details The section requires the applicant to furnish this information 1. Substance name. This will be automatically displayed based on the information you have given in section 5.1

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2. Raw Material. This will be automatically displayed based on the information you have given in section 5.4 3. Active Pharmaceutical Ingredient(s) in INN names. You will be able to search for the active pharmaceutical ingredient that is present in the substance you are importing, in salt/base form, through the Search Ingredient function 4. Quantity present in each unit. You will have to provide the quantity of the controlled drug ingredient present in each product unit. Please note that the default unit of measurement is grams. You will have to adjust the value you wish to provide accordingly Eg, for the XYZ Syrup 100ml, which may have a concentration of active ingredient 5mg/ml, the quantity, in grams, of the active ingredient present in one bottle (product unit) is 0.5g. 5. Unit of Measurement. This is set as grams by default for ease of calculation 6. Base Factor. This will be automatically displayed based on the active ingredient in salt/base form you have selected earlier at section 5.10. 7. Total quantity of units to be imported. This will be automatically displayed based on the information you have given in section 5.14 of Part Five (A) - Substances To Be Imported. 8. Total quantity of substance to be imported. The value will be automatically calculated and displayed by the system. 9. Add the ingredient by clicking on the Add Ingredient button. You will see the page refreshes, and the refreshed page will display the details of the ingredient you have added. You can add more ingredients through the same application sequence, if the substance you are importing contains more than one controlled drug. To go to Part Five (A) Substances To Be Imported to continue with the application, you will have to click the Back button on top of the application webpage. This will bring you back to Part Five (A), and you can go to the next Part Other useful information Computer based online tutorial (CBT) is available to provide a means for applicant to familiarize themselves with the various HSAs online e-services. The CBT is located at http://www.hsa.gov.sg/publish/hsaportal/en/services/cybertutor.html. NOTE: The CBT provided might not be identical to the actual e-services forms, it only provide a means for applicant to have an insight of how our e-services work. You can contact the HSA PRISM and CRIS Helpdesk should you assistance with your application. The Helpdesk is made available via phone, fax or email, and they can be reached at Hotline : 6776-0168 (from 7:00 am to midnight daily) Fax No. : 6872-3054 Email ID. : helpdesk@hsahelp.gov.sg If your queries relate to regulations and licence policies, please contact Manufacturing & Quality Audit Division Tel: 68663516 Fax: 64789068 Email: hsa_certification@hsa.gov.sg

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