AMENDMENT APPLICATION FOR CHINESE PROPRIETARY

MEDICINE (CPM) WHOLESALE DEALERS LICENCE

1. The online form may take an average of 10 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: Layout plan for the premise, specifying the storage areas. Good Distribution Practice Standard Operating Procedures Good Distribution Practice Records

3. The applicant should ensure that you have the valid CRIS user rights to submit the amendment application on behalf of you company before you start the application. 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 to HSA Finance department. The address can be found in the application form.

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Application Form Part Zero Licence/Permit/Certificate/Listing Summary The section requires the applicant to furnish this information 1) Amendment Details (Please provide in this entry the reason for the amendment) The applicant has to make amendment(s) to the licence when the following changes occur: A) Examples of changes involving site inspection Inclusion of new warehouse or change in location/address of current warehouse for the storage of medicinal products/poisons, when the new site has not been audited or approval by HSA yet Renovation of warehouse which involves a change in layout and infrastructure namely with respect to security and storage facilities.

B) Examples of changes that do not involve site inspection. While the following generally do not require an inspection, the authority reserve the right to make the final decision and a site inspection may be conducted. Deletion of existing warehouse Change of applicant Change of company particulars such as company name or address (Note: Such amendment has to be made via the "Change of Company Information" module) If you are in doubt or encounter a situation which is not found in the above lists of examples, please contact us before submission. You will not need to amend any other details at this section. The applicable Licence No, the effective and expiry dates of the existing licence will be displayed for your information. Part One Licence Duration The default licence duration is 1 year thus this section does not require the applicant to fill in any information. Part Two - Companys particular The section requires applicant to fill in the below information 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. You will not need to amend any other details on this section. The company particulars will be displayed for your information. Part Three Applicant Particulars The section requires applicant to fill in the below information 1) Applicant Name 2) Applicant NRIC/Fin 3) Designation

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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 this preferred contact mode is the mode 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 Four Warehouse Particulars The section requires the applicant to furnish this information if there is an amendment to the warehouse particulars. Otherwise, please do not amend any details at this section. To amend the warehouse particulars, you will just have to click on the warehouse of interest, and the page will refresh to display the particulars of the warehouse. Click on Update Warehouse to update any changes you have made. You may also choose to add or remove any of the previously approved warehouses. To add warehouses: 1) Warehouse Addresses (addresses of all the sites where the products would be stored). You will see the page refreshes, and the refreshed page will display the details of the warehouse addresses you have added 2) Storage condition of the warehouse. You will have to provide the optimized warehouse temperature and relative humidity. You can select more than one option for the warehouse temperature 3) Warehouse approved by. Please give details of the agency/institution that approves the use of the warehouse(s) for the storage of health products 4) Add the warehouse address by clicking on the Add Warehouse button. You will see the page refreshes, and the refreshed page will display the details of the warehouse particulars you have added. Other useful information Computer based online tutorial (CBT) is available to provide a means for applicant to familiarize 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 may refer to the module on Apply for Licence to Import Medicinal Products, available under Manufacturing and Quality Audit as a guide to familiarise yourself with the module. 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_gdp@hsa.gov.sg

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