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Amendment Application For Licence To Import Medicinal Products

The document provides instructions for filling out an online application form to amend a license to import medicinal products in Singapore. It summarizes the information required in each part of the application, including amendment details, company particulars, warehouse details, products to be imported, and license duration. Assistance resources like a computer-based tutorial and helpdesk contact information are also listed.

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William Chandra
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44 views

Amendment Application For Licence To Import Medicinal Products

The document provides instructions for filling out an online application form to amend a license to import medicinal products in Singapore. It summarizes the information required in each part of the application, including amendment details, company particulars, warehouse details, products to be imported, and license duration. Assistance resources like a computer-based tutorial and helpdesk contact information are also listed.

Uploaded by

William Chandra
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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AMENDMENT APPLICATION FOR LICENCE TO IMPORT MEDICINAL PRODUCTS

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.htm. 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: Authorisation Letter from product licence holder Good Distribution Practice Standard Operating Procedures Good Distribution Practice Records Layout plan for the premise Store approval Letter

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. User required a Singpass or HSA Pin to login the system for authentication and authorization. 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) Change (inclusion or deletion) of product to be imported 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 - 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 could also fill the billing address if it is different from the Company address. If the company is registered with CRIS, the above information will be pre-populated. Part Two Applicant Particulars The section requires applicant to fill in the below 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) Preferred Contact mode

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(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 Three 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. Part Four Products to be Imported The section requires the applicant to furnish this information if there is an amendment to the products authorized to be imported by the company. Otherwise, please do not amend any details at this section. To remove the particulars of the product to be imported, you will have to select the tick boxes next to the product of interest and click on Remove. The page will refresh to display the remaining other products to be imported by your company. To add particulars of product to be imported: 1) Product Licence Number. You will have to provide the product licence number of the product that your company is authorized to import. You will see the page refreshes, and the refreshed page will display the details of the particulars of the product you have added. 2) Add more products by clicking the Add Product button. You will see the page refreshes, and the refreshed page will display the details of the particulars of the product you have added. Part Five Licence Duration The default licence duration is 1 year thus this section does not require the applicant to fill in any information. 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.

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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. : [email protected] If your queries relate to regulations and licence policies, please contact Manufacturing & Quality Audit Division Tel: 68663516 Fax: 64789068 Email: [email protected]

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