Email Worksheet The application form has six parts: 1) General SUBJECT: Information, 2) Establishment Information, 3) Product Information, 4) Supporting Information, 5) Sources and Clients, and 6) Applicant Information. In the worksheet 'Form' (with the red tab) you will see a dashboard where the different parts are identified. If the part is BODY: appropriately filled up, a green 'PROCEED' will be indicated.Required fields will appear sequentially.To minimize errors and confusion, it is recommended that a blank form be used for every application. If the form is appropriately filled up, the composed body text (in the Printing Instructions green box) will appear. (Please print the following parts Be careful to paste the body text completely as text For For Dru Drug g Regi Regist stra rati ti (not as an image or as an attachment). DON'T attach any For For Non Non-D -Dru rug g Reg Regis istr trat atii file to the email request. For Licensi
Application Process Overview
Downloa Application form is downloaded from www.fda.gov.ph
The integr integrat ated ed applic applicati atio o Registr Registratio ation n applicatio applications, ns, a advertisements are also now
Fill Up Fo Application form is filled up correctly
The application ion form has six p Product Information, 4) Sup Info Inform rmat atio ion. n. If the the pa pa indicated.Required indicated.Required fields will compose
Email Send an email to
[email protected]
In the the XLS XLS appl applic icat atio ion n for form, m, t email that should be sent to the email. Include CCs as nee required during submission. to ten app
Scheduli Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission
The FDA FDA will will deter determin mine e th Cent Center ers. s. A quot quota a wil willl be set set f day day. Mult Multip iple le appl applic ica ation tionss s Reque equessts for for spec specif ific ic sche schedu du within 10 w
Pay Fees are paid either at Land Bank branches or at the main FDA cashier
Onc Once a DTL is recei eceiv ved, ed, pa paym Bank of the Philippines, The be rece receiv ived ed for for the the day day.. A co co form are required to process p provided. Ch Check th that th the tr trac
Check Check if all requirements are in order
Be sure that you have a ch doc documen umentts. Don' Don'tt for forg get to h all requirements should be s XLSX co copy of of th the accomplis malicious software. A copy
Submissi Application is filed in on schedule
Only Only appl applic icat atio ions ns sch sched edule uled df be required at submission. documents. Remember the through pa
[email protected]. Sh Sh for another sch
IMPORTANT READ THIS PAGE CAREFULLY. Provide information only when asked for.
f the worksheet 'Form' if applicable) n (excluding amendments and compliances): n (excluding amendments and compliances): ng (exclusing amendments and compliances): For All Other Applications:
pages 1 and 4. pages 1 and 3. pages 1 and 2. page 1 only.
d n form in XLS or XLSX format is used for both License and well as amendments and other certifications. Promos and overed in the application form. Remember that a valid LTO is required for a CPR.
m arts: 1) General Information, 2) Establishment Information, Information, 3) orting Information, 5) Sources and Clients, and 6) Applicant t is appropriately filled up, a green 'PROCEED' will be appear sequentially. sequentially. If the form is appropriately filled up, the body text (in the green box) will appear.
he worksheet 'Email' composes the subject and body of the
[email protected]. Copy and paste the appropriate fields onto ed. The XLS or XLSX file should not be attached but it will be ny attachment will will lead to rejection of schedule request. Up lications in a single email are acceptable.
g e schedule of applications according to the priority of the r the total number of applications that can be scheduled in a ent in a single email may be scheduled over separate days. days. les will not be accommodated. Receiving Receiving will be scheduled orking days of receipt of application email.
nt can be made immediately through any branch of the Land ain FDA cashier will only accommodate accommodate those scheduled to py of the DTL provided by FDA and a copy of the application ayment. Indicate Indicate in the application form the tracking number king number indicated in the DTL is indicated in the proof of payment.
cklist of requirements and that you have all the necessary ave the petition or declaration form notarized. A softcopy of tored in a USB device to facilitate transfer. Include an XLS or hed application form. Please keep your USB devices free of of the OnColl Payment Slip is also required at the point of submission.
n or the day will be accommodated. Hard copies will no longer . Don't forget to get back the USB devices used to transfer RSN number of each application. Use the RSN to follow-up ould you fail to complete submission on the set date, queue edule through
[email protected] [email protected] .ph using the RSN.
APPLICATION FORM Document Tracking Number
Description (Optional):
1 GENERAL INFORMATION 1.1 Product Center:
APPLICATION FORM STATUS GENERAL INFORMATION: INFORMATION: ESTABLISHMENT ESTABLISHMENT INFORMATION: INFORMATION: PRODUCT INFORMATION: INFORMATION: SUPPORTING INFORMATION: SOURCES & CLIENTS: APPLICANT INFORMATION: INFORMATION:
This form was last edited on 3 June 2014, 7:18 PM
5 SOURCES & CLIENTS
1) Raw Material, Additive or Ingredient; 2) Raw Material, Additive or Ingredient; 3) Raw Material, Additive or Ingredient; 4) Raw Material, Additive or Ingredient; 5) Raw Material, Additive or Ingredient; 6) Raw Material, Additive or Ingredient; 7) Raw Material, Additive or Ingredient; 8) Raw Material, Additive or Ingredient; 9) Raw Material, Additive or Ingredient; 10) Raw Material, Additive or Ingredient; 11) Raw Material, Additive or Ingredient; 12) Raw Material, Additive or Ingredient; 13) Raw Material, Additive or Ingredient; 14) Raw Material, Additive or Ingredient; 15) Raw Material, Additive or Ingredient;
Provide in this space a description of the product in terms of color, texture, functional properties, flavor, among others, as applicable.
Provide in this space a description of the product in terms of rheology, thermal, and geometry properties among others, as applicable; Indicate if appropriate microbiological cultures present in the product
Use this space to explain how the lot code used on the product label is correctly interpreted
1) Active Pharmaceutical Ingredient; 2) Active Pharmaceutical Ingredient; 3) Active Pharmaceutical Ingredient; 4) Active Pharmaceutical Ingredient; 5) Active Pharmaceutical Ingredient; 6) Active Pharmaceutical Ingredient; 7) Active Pharmaceutical Ingredient; 8) Active Pharmaceutical Ingredient; 9) Active Pharmaceutical Ingredient; 10) Active Pharmaceutical Ingredient; 11) Active Pharmaceutical Ingredient; 12) Active Pharmaceutical Ingredient;
1) API Manufacturer, Address Address Address; 2) API Manufacturer, Address Address Address; 3) API Manufacturer, Address Address Address; 4) API Manufacturer, Address Address Address; 5) API Manufacturer, Address Address Address; 6) API Manufacturer, Address Address Address; 7) API Manufacturer, Address Address Address; 8) API Manufacturer, Address Address Address; 9) API Manufacturer, Address Address Address; 10) API Manufacturer, Address Address Address; 11) API Manufacturer, Address Address Address; 12) API Manufacturer, Address Address Address;
1) API Supplier, Address Address Address; 2) API Supplier, Address Address Address; 3) API Supplier, Address Address Address; 4) API Supplier, Address Address Address; 5) API Supplier, Address Address Address; 6) API Supplier, Address Address Address; 7) API Supplier, Address Address Address; 8) API Supplier, Address Address Address; 9) API Supplier, Address Address Address; 10) API Supplier, Address Address Address; 11) API Supplier, Address Address Address; 12) API Supplier, Address Address Address;
LTO GENERAL INFO COMPANY INFORMATION INFORMATPPLICANT INFORMATPPLICANT INFORMATIO
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Date Issued
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