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    LTO and CPR Processing

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    verkie
    There are two application forms for licensing and product registration with the FDA: the License to Operate (LTO) form and the Certificate of Product Registration (CPR) form. Applicants must fill out the appropriate form completely and accurately, including all required information and documents. Completed applications should then be emailed to the FDA for scheduling and subsequent in-person submission on the scheduled date, bringing all required documents on a USB drive.

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    LTO and CPR Processing

    Uploaded by

    verkie
    3K views2 pages
    There are two application forms for licensing and product registration with the FDA: the License to Operate (LTO) form and the Certificate of Product Registration (CPR) form. Applicants must fill out the appropriate form completely and accurately, including all required information and documents. Completed applications should then be emailed to the FDA for scheduling and subsequent in-person submission on the scheduled date, bringing all required documents on a USB drive.

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    There are two application forms for licensing and product registration with the FDA: the License to Operate (LTO) form and the Certificate of Product Registration (CPR) form. Applicants must fill out the appropriate form completely and accurately, including all required information and documents. Completed applications should then be emailed to the FDA for scheduling and subsequent in-person submission on the scheduled date, bringing all required documents on a USB drive.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    3K views2 pages

    LTO and CPR Processing

    Uploaded by

    verkie
    There are two application forms for licensing and product registration with the FDA: the License to Operate (LTO) form and the Certificate of Product Registration (CPR) form. Applicants must fill out the appropriate form completely and accurately, including all required information and documents. Completed applications should then be emailed to the FDA for scheduling and subsequent in-person submission on the scheduled date, bringing all required documents on a USB drive.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    2/5/2014

    LTO and CPR Processing

    Downloadables
    LTO and CPR Processing
    Download. There are two application forms: License to Operate (LTO), and Certificate of Product Registration (CPR). Make sure you have the right form. Remember that a valid LTO is required for a CPR. Only one establishment per LTO application form. Only one product per CPR application form. Fill up Form. To facilitate the process, please provide as much information as possible. Avoid abbreviations. Use 'Not Applicable' when appropriate. Double check the spelling. Multiple applications in a single email are acceptable. Use the the full name of the applicant establishment as subject. Don't forget to indicate as well the region where the establishment is based. Email. In the XLS application form, the worksheet 'Email' composes the subject and body of the email that should be sent to pair@fda.gov.ph. Copy completely and paste the appropriate fields onto the email. Include CCs as needed. The XLS file does not need to be attached but it will be required during submission. Scheduling. The FDA will determine the schedule of applications according to the priority of the Centers.
    http://www.fda.gov.ph/industry-corner/downloadables/237-fda-public-assistance-information-and-receiving-pair/111583-lto-and-cpr-processing?tmpl=component 1/2

    2/5/2014

    LTO and CPR Processing

    A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be scheduled over separate days. Requests for specific schedules will not be accommodated. Receiving will be scheduled within 10 working days of receipt of application email. Pay. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the RSN provided. The RSN is indicated in the DTL. The amount that is due is indicated at the bottom of the application form. Check that the RSN indicated in the Document Tracking Log is indicated in the proof of payment. Check. The requirements for every application differs. Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the declaration form notarized. A softcopy of all documents pertinent to the application is required to be stored in a USB device to facilitate transfer. Include an XLS copy of the accomplished application form. Please keep your USB devices free of malicious software. Submission. Only applications scheduled for the day will be accommodated. Hard copies will no longer be required at submission. Don't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using the RSN. Attachments:
    FDA Application Form 28 Jan 2014 - CPR FDA Application Form - LTO

    http://www.fda.gov.ph/industry-corner/downloadables/237-fda-public-assistance-information-and-receiving-pair/111583-lto-and-cpr-processing?tmpl=component

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