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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 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 [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.

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Page 1: LTO and CPR Processing

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.

Page 2: LTO and CPR Processing

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