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2/5/2014 LTO and CPR Processing
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
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 LTOapplication form. Only one
product per CPR application
form.
Fill up Form. To facilitatethe process, please provide
as much information as
possible. Avoid
abbreviations. Use 'Not
Applicable' whenappropriate. Double check
the spelling. Multiple
applications in a single email
are acceptable. Use the the
full name of the applicantestablishment 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 theemail that should be sent to
[email protected]. 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.
2/5/2014 LTO and CPR Processing
http://www.fda.gov.ph/industry-corner/downloadables/237-fda-public-assistance-information-and-receiving-pair/111583-lto-and-cpr-processing?tmpl=component… 2/2
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 applicationemail.
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 [email protected].
Should you fail to complete submission on the set date, queue for another schedule through
[email protected] using the RSN.
Attachments:
FDA Application Form 28 Jan 2014 - CPR
FDA Application Form - LTO