Email Worksheet

(Please print the following parts of the worksheet 'Form' if applicable)

SUBJECT:
BODY:
The application form has six parts: 1) General
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
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
green box) will appear.
Be careful to paste the body text completely as text
(not as an image or as an attachment). DON'T attach any
file to the email request.
Application Process Overview
For All Other Applications:
Printing Instructions
For Drug Registration (excluding amendments and compliances):
For Non-Drug Registration (excluding amendments and compliances):
For Licensing (exclusing amendments and compliances):
Fill Up Form
Application form is filled up
correctly
The application form has six parts: 1) General Information, 2) Establishment Information, 3)
Product Information, 4) Supporting Information, 5) Sources and Clients, and 6) Applicant
Information. If the part is appropriately filled up, a green 'PROCEED' will be
indicated.Required fields will appear sequentially. If the form is appropriately filled up, the
composed body text (in the green box) will appear.
Download
Application form is
downloaded from
www.fda.gov.ph
The integrated application form in XLS or XLSX format is used for both License and
Registration applications, as well as amendments and other certifications. Promos and
advertisements are also now covered in the application form. Remember that a valid LTO is
Pay
Fees are paid either at Land
Bank branches or at the main
FDA cashier
Once a DTL is received, payment can be made immediately through any branch of the Land
Bank of the Philippines, The main FDA cashier will only accommodate those scheduled to
be received for the day. 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 tracking number
provided. Check that the tracking number indicated in the DTL is indicated in the proof of
Scheduling
Within two working days, a
Document Tracking Log (DTL)
is sent with a schedule for
submission
The FDA will determine the schedule of applications according to the priority of the
Centers. 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.
Email
Send an email to
pair@fda.gov.ph
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 and paste the appropriate fields onto
the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be
required during submission. Any attachment will lead to rejection of schedule request. Up
to ten applications in a single email are acceptable.
Submission
Application is filed in on
schedule
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
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.
Check
Check if all requirements are
in order
Be sure that you have a checklist of requirements and that you have all the necessary
documents. Don't forget to have the petition or declaration form notarized. A softcopy of
all requirements should be stored in a USB device to facilitate transfer. Include an XLS or
XLSX copy of the accomplished application form. Please keep your USB devices free of
malicious software. A copy of the OnColl Payment Slip is also required at the point of
IMPORTANT
(Please print the following parts of the worksheet 'Form' if applicable)
pages 1 and 4.
pages 1 and 3.
pages 1 and 2.
page 1 only.
Provide information only
when asked for.
Application Process Overview
READ THIS PAGE CAREFULLY.
For All Other Applications:
Printing Instructions
For Drug Registration (excluding amendments and compliances):
For Non-Drug Registration (excluding amendments and compliances):
For Licensing (exclusing amendments and compliances):
Fill Up Form
The application form has six parts: 1) General Information, 2) Establishment Information, 3)
Product Information, 4) Supporting Information, 5) Sources and Clients, and 6) Applicant
Information. If the part is appropriately filled up, a green 'PROCEED' will be
indicated.Required fields will appear sequentially. If the form is appropriately filled up, the
composed body text (in the green box) will appear.
Download
The integrated application form in XLS or XLSX format is used for both License and
Registration applications, as well as amendments and other certifications. Promos and
advertisements are also now covered in the application form. Remember that a valid LTO is
required for a CPR.

Once a DTL is received, payment can be made immediately through any branch of the Land
Bank of the Philippines, The main FDA cashier will only accommodate those scheduled to
be received for the day. 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 tracking number
provided. Check that the tracking number indicated in the DTL is indicated in the proof of
payment.
Scheduling
The FDA will determine the schedule of applications according to the priority of the
Centers. 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.
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 and paste the appropriate fields onto
the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be
required during submission. Any attachment will lead to rejection of schedule request. Up
to ten applications in a single email are acceptable.
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.
Check
Be sure that you have a checklist of requirements and that you have all the necessary
documents. Don't forget to have the petition or declaration form notarized. A softcopy of
all requirements should be stored in a USB device to facilitate transfer. Include an XLS or
XLSX copy of the accomplished application form. Please keep your USB devices free of
malicious software. A copy of the OnColl Payment Slip is also required at the point of
submission.
1 GENERAL INFORMATION
This formwas last edited on 3 June 2014, 7:18 PM
5 SOURCES & CLIENTS
1.1 Product Center:
GENERAL INFORMATION:
SOURCES & CLIENTS:
APPLICANT INFORMATION:
Document Tracking Number
SUPPORTING INFORMATION:
Description (Optional):
APPLICATION FORM
PRODUCT INFORMATION:
ESTABLISHMENT INFORMATION:
APPLICATION FORM STATUS
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, avor, 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
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;
12) API Manufacturer, Address Address Address;
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;
8) API Supplier, Address Address Address;
9) API Supplier, 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;
10) API Supplier, Address Address Address;
11) API Supplier, Address Address Address;
12) API Supplier, 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;
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0 ## ## ## 1# 1- 1- 01 1- 1 0 0 ## 1 1- 1; 1 1 ## ## ##
CPR
DOC TRACK NUMBER CENTER AUTHORIZATION APPLICATION TYPE Applicant Company Address E-mail Adress TINContact No. LTO No. Validity Brand Name Generic Name Dosage Strength and Form Classification Essential Drug List Pharmacologic Category Manufacturer Address TIN LTO No Validity Trader Address TINLTO No Validity Repacker/ Packer Address TINLTO No
0 ## ## ## 1#11-10 1 01;01;01 0 ## 1 0 0/ 00 0 0 ## ## ## ## ## ## ## ## ## ## ## ##
Number Source/ Client Type of Establishment Name Address Local FDA License TINContact 1 Contact 2
1 0 0 0 0 0 0
Cosmetic CCRR Additional Package Size PSZ 2 0 0 0 0 0 0
Drug CDRR Change of Importer/ Distibutor CID 3 0 0 0 0 0 0
Food CFRR Change/ Addition of Brand Name CBN 4 0 0 0 0 0 0
Household and Urban Hazardous Substances CCRR Shelf Life SLF 5 0 0 0 0 0
Medical Devices CDRR PCPR Conversion PCC 6 0 0 0 0 0 0
Iodized Salt CFRR Warehouse: Add/ Change WRH 7 0 0 0 0 0 0
Source: Add/ Delete SAD 8 0 0 0 0 0 0
Source: Change of Business Name/Address SCN 9 0 0 0 0 0 0
License to Operate LTO Change of Business Name/Address CBN 10 0 0 0 0 0 0
Notification NTN Change of Key Personnel CKP
Product Registration CPR Package Design PDS
Promos and Ads PAD
Clinical Trials CTR
Other Authorization OTH
Initial INT 1
Renewal RNW 0
Automatic Renewal ARN Other OTH
Variation VAR Finished Product FIP
Amendment AMD Raw Material RAW
Compliance COM Activity: Additional ACT
Re-Issuance REI Product Line PRL
Reapplication RAP Nothing Further NOF
Home Solicitation HSO Reclassification RCL
Sales Promotion SPR
Discount Scheme DSC
Amendment, Major (including Extension) AMJ
Amendment, Minor AMN
Generic Labelling Exemption GLE
Free Sale, Certificate of CFS
Pharmaceutical Product, Certificate of PHP
Export Certificate EXP
Brand Name Clearance BRN
Provisional Permit to Market PPM
PRODUCT INFORMATION
COMPANY INFORMATION LTO INFORMATION APPLICANT INFORMATION GENERAL INFORMATION
GENERAL INFORMATION COMPANY INFORMATION
APPLICATI
ON
AMENDM
ENT 1
AMENDM
ENT 2
AMENDM
ENT 3
Exemption, Certificate of CEX
HACCP Certificate HCP
OT
HE
DE
LE
Fe
e
LR
F
Su
rc
To
tal
OR
No
Da
te
## ## ## ## 0 ##
Validity Importer Address TIN LTO No Validity Distributor Address TINLTO No Validity Shelf-life Storage Condition Packaging Suggested Retail Price No. of Samples Expiry Date CPR Validity Registration Number Registration Amendment 1 Amendment 2 Amendment 3 Certification Others FeeLRF Surcharge Total OR No.
## ## ## ## ## ## ## ## 0 0 0 # 0 ## ## ## ## ## ## ## ## ## ## ## ##
PAYMENT DETAILS
PRODUCT INFORMATION
APPLICATION TYPE
OTHER REQUEST PAYMENT DETAILS
AMENDM
ENT 3
Date Issued
##
PAYMENT DETAILS