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APPLICATION FOR A GOOD MANUFACTURING PRACTICE (GMP) CERTIFICATE

1. The online form may take an average of 15 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)

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 You would not need to make any payment during the on-line submission. The exact amount payable would be make known to you at a later stage. Payment would then be made via GIRO (preferred) or cheque, made payable to Health Sciences Authority. 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 One GMP Certificate Particulars 1) Applicant can select the following scope of certification using the Drop down list: Active Pharmaceutical Ingredients (API) Medicinal products in finished dosage form Cosmetic products Chinese Proprietary Medicines Part Two Company Particulars 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 Three 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 Four Manufacturing Facility Particulars/Manufacturer Details The section requires the applicant to furnish this information 1) Manufacturers Licence / Application No / OAP No. Applicant to key in the Manufacturers Licence (ML) no. or ML application no. (if ML application is still pending approval) or Overseas Audit Programme (OAP) application no. (if applicable). By keying in the above information, when the applicant clicked the retrieve details button, the manufacturer address will be automatically displayed. 2) Name of Manufacturer. The applicant would need to provide the name of manufacturer and address of manufacturing site through Postal Code retrieval function if a Manufacturers Licence or OAP application no is not applicable 3) Number of licensed product manufactured. Applicant to provide in the number of licenced product manufactured 4) Number of non-registrable product manufactured. Applicant to provide in the number of nonregistrable product manufactured 5) Applicant to click save button to save the details provided. The process can be repeated if there are a number of manufacturing sites with different addresses.

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Part Five Other Products Manufactured in Same Premises The section requires applicant to furnish this information 1) Categories of products. Please select from the list provided the substance(s) your company is also manufacturing/assembling. You can select more than one option Part Six Warehouse/Store Particulars The section requires the applicant to furnish this information 1) Under the address type, applicant needs to indicate if the warehouse is situated locally or overseas. - If applicant selects local, applicant could provide the warehouse address through the Postal Code retrieval function - If applicant click overseas, applicant need to provide in the warehouse address. Please enter the address of the exporter at section 6.1.2 and the exporters country of residence at section 6.1.3. Information such as State and City is not necessary if the details are given in section 6.1.2 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 Seven Contract Testing Laboratory Particulars The section requires applicant to furnish these information 1) Is a contract testing laboratory engaged to conduct laboratory tests for your company? If your answer to the question is No, you can proceed to the next Part. If your answer is Yes, you will be required to give details of the contract testing laboratory in the following sections 2) Name and address of the contract testing laboratory 3) Type of analytical test performed by the laboratory based on your contract. You will only need to give a brief description of the test(s) performed 4) If the contract testing laboratory is accredited to any international quality system standards, and the scope of accreditation. You will only need to give a brief description of the scope of accreditation 5) Add the contract testing laboratory by clicking on the Save button. You will see the page refreshes, and the refreshed page will display the details of the contract testing laboratory you have added Part Eight Importing Country / Countries The section requires applicant to furnish these information 1) Name of importing country/countries. Applicant can select the list of importing country/countries by using the Drop down list provided.

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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 may refer to the module on Apply for Licence to Manufacturer/Assemble 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_certification@hsa.gov.sg

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