Email Worksheet

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. Printing Instructions
(Please print the following parts of the worksheet 'Form
SUBJECT: IVer Medicare Laboratories #II
BEGIN:CPR;CDRR;IVer Medicare
Laboratories #II#Processor#LTO-
00000001234;VAR#0#Human Drug,
BODY:
Branded#IVERCOL#PARACETAMOL#Nothing
Further#MiV-
PA09#0#0#0;500;10;0;510:END
For Drug Registration (excluding amendmen
For Non-Drug Registration (excluding amendmen
For Licensing (exclusing amendmen
For A

Application Process Overview

 IMPORTANT
ories #II

READ THIS PAGE CAREFULLY.

Medicare Provide information only
ssor#LTO- when asked for.
Human Drug,
RACETAMOL#Nothing

;510:END

of the worksheet 'Form' if applicable)

on (excluding amendments and compliances): pages 1 and 4.
on (excluding amendments and compliances): pages 1 and 3.
ng (exclusing amendments and compliances): pages 1 and 2.
For All Other Applications: page 1 only.
 APPLICATION FORM 51SOURCES & CLIENTS
None Source None
PROCEED

5.1.1 Type of Establishment:

Document Tracking Number APPLICATION FORM STATUS

GENERAL INFORMATION: PROCEED
ESTABLISHMENT INFORMATION: PROCEED
Description (Optional): PRODUCT INFORMATION: PROCEED
SUPPORTING INFORMATION: PROCEED
1 GENERAL INFORMATION PROCEED SOURCES & CLIENTS: PROCEED
1.1 Product Center: Drug
APPLICANT INFORMATION: PROCEED
ORDER OF PAYMENT Mobile:
1.2 Authorization: Product Registration
Amount Due: Php 510.00
Fee : Php 500.00
Legal Research Fee : Php 10.00
1.3 Type: Variation
Surcharge : Php -
OR Number :
1.4 Primary Activity: Processor
Date Paid:
Computation Valid Until: 08 March, 2024
This form was last edited on 13 October 2016, 10:28 AM.
1.5 Current License LTO-00000001234 4 SUPPORTING INFORMATION
Number: PROCEED
1.5.1 Expiry Date: 08-Mar-24 PROCEED
Your License will expire in 729 days.
1.6 Current Registration Nothing Further
Number:
1.6.1 Expiry Date: 08-Mar-24
PROCEED
Your Registration will expire in 729 days.

PROCEED

1.7.1 Type of Minor - Prior Approval 1 to 20

Variation 1:
1.7.1.1 Variation PA09
Code 1:
1.7.2 Type of Nothing Further
Variation 2:

2 ESTABLISHMENT INFORMATION PROCEED

2.1 Name of Establishment
IVer Medicare Laboratories
2.2 Declared Capital (PhP): 50 M and above
2.3 Tax Identification Number: 521-243-000
2.4 Office Address 2.5.1 Region: II
Minante 1, Cauayan City, Isabela
2.5 Warehouse Address 2.6.1 Region: II
Minante 1, Cauayan City, Isabela
6 APPLICANT INFORMATION PROCEED
2.6 Plant Address 2.7.1 Region: II
Minante 1, Cauayan City, Isabela The undersigned attest to have provided true and complete information in this form, and to provide complete
requirements at the time of submission. The undersigned agree to strict compliance with the rules and regulations of
2.7.0 E-mail Address: ivermedicarelab@gmail.com the Food and Drug Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage
2.7.1 Contact Detail 1 Mobile: 9222234567 Practice (GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree
to grant authority to the FDA to verify the truthfulness of the information provided with this application.
2.7.2 Contact Detail 2 Landline: 6421234
2.7.3 Contact Detail 3 Fax: 987654321
6.1 APPROVING AUTHORITY
Signature 6.1.5 Mailing Address
Minante 1, Cauayan City, Isabela
3 PRODUCT INFORMATION PROCEED
3.1 Product Category: Human Drug, Branded
6.1.1.0 Family
Latest photo of applicant
Name: Apalla
3.2 Product/Brand Name 3.2.1 Generic Name 6.1.1.1 First
Chabelita
IVERCOL PARACETAMOL Name(s): 6.1.6.0 E-mail Address:
6.1.1.2 Middle ivermedicarelab@gmail.com
D.
Name: 6.1.6.1 Contact Detail 1
6.1.2 Designation: Owner/ General Manager/ President Mobile: #FMT
6.1.3 Tax ID Number: 456-579-123 6.1.6.2 Contact Detail 2
6.1.4.0 Type of Gov't ID: Professional Regulatory Commission Landline: 6421234
6.1.4.1 ID Number: 789-123 6.1.6.3 Contact Detail 3
3.2.2 EDL? No 3.2.3 Samples?: No 6.1.4.2 Date Expiry: 08-Feb-23 Fax: 987654321
3.3.0 Drug Classification: OTC 6.2 APPLICANT
3.3.1 Dosage Strength: 500mg Signature 6.2.5 Mailing Address
3.3.2 Dosage Form: Tablet Minante 1, Cauayan City, Isabela
3.3.3 Pharma Analgesic
Category:
Blister Packaging PROCEED 6.2.2.0 Family
3.4.0 Latest photo of applicant
Name: Apalla
Packaging:
6.2.2.1 First
Chabelita
3.4.1 Presentation/GPIN/GTIN: 500mg(1098765432) Name(s): 6.2.6.0 E-mail Address:
3.4.2 Storage Condition: NMT 30 degree Celcius 6.2.2.2 Middle ivermedicarelab@gmail.com
D.
3.4.3 Shelf-life: 3 years Name: 6.2.6.1 Contact Detail 1
3.4.4 Sugg. Retail Price Php 5.00 6.2.2 Designation: Company Pharmacist Mobile: #FMT
6.2.3 Tax ID Number: 456-579-123 6.2.6.2 Contact Detail 2
6.2.4.0 Type of Gov't ID: Social Security System Landline: 6421234
6.2.4.1 ID Number: 789-123 6.2.6.3 Contact Detail 3
6.2.4.2 Date Expiry: 08-Feb-23 Fax: 987654321

Off-white to beige, semi biconvex film-
CLOPIDOGREL (as BISULFATE) coated tablet with score on one side and
plain on the other side
Provide in this space a description of the
product in terms of rheology, thermal, and Use this space to explain how the lot code
geometry properties among others, as
used on the product label is correctly
applicable; Indicate if appropriate
microbiological cultures present in the interpreted
product
 Drug

This is the declaration form for pharmaceutical product registration by the Food and Drug Administration of the Philippines.

DECLARATION
We assume primary responsibility and/or stewardship over the product in case of liability, adverse events, or other public health & safety issues
arising from its use. We agree to have in good faith exerted due diligence in ensuring thatthird-party intellectual property rights are not infringed.
We further agree and bind ourselves that the label of the product shall at all times conform to the labeling regulations, and shall not be presented
including any advertisement of the product in a manner that is false, deceptive, misleading, or contrary to public morals/ public policy. Non-
observance of any of the undertakings in this declaration is deemed a misrepresentation which is a ground for disapproval of this application or, if
approved, the suspension or cancellation of the product registration.

Enclosed are the documents stated in the Checklist of Requirements for Registration and representative sample of our product.

We categorically declare that all data and information submitted in connection with this application as well as other submission in
the future are true and correct and reflect the total information available. We certify that we have examined the following statements
and we attest to their accuracy and truthfulness :
1.    The current Good Manufacturing Practice Guidelines is applied in full in the manufacture of this product.
2.  The formulation per dosage form is in agreement with the master formula and with the batch manufacturing record forms.
3.    The manufacturing procedure is exactly as specified in the master formula and batch manufacturing records.
4.    Product covered by this declaration will not undergo any change in formulation, dosage form, strength, therapeutic indication, manufacturer,
manufacturing process, labelling or commercial presentation without prior approval of the Food and Drug Administration.

5.    Each batch of all starting materials is tested or certified (in an accompanying certificate of analysis for that batch) against the full specifications in the
accompanying documentation and fully complied with those specifications cited in the claimed reference official monograph before it is released for
manufacturing purposes.
6.    All batches of active pharmaceutical ingredient/s (API) are obtained from the following sources:
Active Pharmaceutical Ingredient (API) Name and Address of API Manufacturer Name and Address of API Supplier
CLOPIDOGREL (AS BISULFATE) NINBO BEITONG IMP. & EXP. CO. LTD., INDIA KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA
2) Active Pharmaceutical Ingredient; 2) API Manufacturer, Address Address Address; 2) API Supplier, Address Address Address;
3) Active Pharmaceutical Ingredient; 3) API Manufacturer, Address Address Address; 3) API Supplier, Address Address Address;
4) Active Pharmaceutical Ingredient; 4) API Manufacturer, Address Address Address; 4) API Supplier, Address Address Address;
5) Active Pharmaceutical Ingredient; 5) API Manufacturer, Address Address Address; 5) API Supplier, Address Address Address;
6) Active Pharmaceutical Ingredient; 6) API Manufacturer, Address Address Address; 6) API Supplier, Address Address Address;
7) Active Pharmaceutical Ingredient; 7) API Manufacturer, Address Address Address; 7) API Supplier, Address Address Address;
8) Active Pharmaceutical Ingredient; 8) API Manufacturer, Address Address Address; 8) API Supplier, Address Address Address;
9) Active Pharmaceutical Ingredient; 9) API Manufacturer, Address Address Address; 9) API Supplier, Address Address Address;
10) Active Pharmaceutical Ingredient; 10) API Manufacturer, Address Address Address; 10) API Supplier, Address Address Address;
11) Active Pharmaceutical Ingredient; 11) API Manufacturer, Address Address Address; 11) API Supplier, Address Address Address;
12) Active Pharmaceutical Ingredient; 12) API Manufacturer, Address Address Address; 12) API Supplier, Address Address Address;

7.    No batch of active pharmaceutical ingredient will be used unless a copy of the batch certificate established by the active ingredient manufacturer listed
above is available.
8.    Each batch of the finished product is tested and certified (in an accompanying certificate of analysis for that batch), against the full specifications in
the accompanying documentation and fully complied with the specifications cited in the claimed reference official monograph before it is released for
sale.
9.    The person releasing the product for sale is an authorized and/or qualified person.
10.  The procedures for control of the finished product have been validated for this formulation. The assay method has been validated for accuracy,
precision, specificity and linearity.
11.  The market authorization holder has a standard operating procedure for handling adverse reaction reports, and implementation of recall of its products.
12.  All the documentation referred to in this application is available for review during an audit or inspection.

WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THROUGH BOTH GOVERNMENT AND PRIVATE
RESOURCES THE AUTHENTICITY OF ALL THE INFORMATION AND DOCUMENTS SUBMITTED .
ACKNOWLEDGEMENT
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20 ______ at ______________________________

_______________________________________________________ , Philippines, personally appeared the following :

Name and Signature Identification Number Expiry Date of ID Place Issued

Professional Regulatory 08-Feb-23

Commission:789-123
1) Chabelita D. Apalla ______________________________
Social Security System:789-123 08-Feb-23
2) Chabelita D. Apalla ______________________________
Known to me and to me known to be the same persons who execute the application form and this declaration form, and they acknowledged to me that the same
is their free and voluntary act and deed. WITNESS MY HAND AND SEAL on the date and place first above written.
Doc. No. : _____________________________
Page No. : ____________________________
Book No. : ____________________________
Series of : _____________________________
 Department of Health
Food and Drug Administration
APPLICATION FORM STATUS: APPLICATION FORM
4 SUPPORTING INFORMATION
1
GENERAL INFORMATION: PRO 1 0 0 1 0 0 0 SOURCES & CLIENTS: PRO 1 1 0 1
ESTABLISHMENT INFORMATION: PRO 1 0 0 1 1 Document Tracking Number 1 PR1
OC
PRODUCT INFORMATION: PRO 1 0 0 0 0 1 0 1 EE1
SUPPORTING INFORMATION: PRO 1 0 1 1 1 1 0 1 1 PRO 1 1D
APPLICANT INFORMATION: PRO 1 1 1 1 Description (Optional):
PAYMENT INFORMATION: 1 0 0
GENERAL INFORMATION 2 ESTABLISHMENT INFORMATION 1 1

1.1 Product Center: Drug 1.4 Primary Activity: Processor

2.1 Name of Establishment 1 1
1.2 Authorization: Product Registration
IVer Medicare Laboratories
1.3 Type: Variation 2.2 Declared Capital (PhP): 50 M and above 1 1
2.3 Tax Identification Number: 521-243-000
2.4 Office Address 2.5.1 Regi II
1 1
1.5 Current License Number: LTO-00000001234 Minante 1, Cauayan City, Isabela
1.5.1 Expiry Date: 8-Mar-2024 2.5 Warehouse Address 2.6.1 Regi II
1 1
Your License will expire in 729 days. Minante 1, Cauayan City, Isabela
2.6 Plant Address 2.7.1 Regi II
1.6 Current Registration NumbeNothing Further 1 1
1.6.1 Expiry Date: 8-Mar-2024 Minante 1, Cauayan City, Isabela
2.7.0 E-mail Address: ivermedicarelab@gmail.com
Your Registration will expire in 729 days. 2.7.1 Contact Detail 1 Mobile: 9222234567 1 1
0 2.7.2 Contact Detail 2 Landline: 6421234
0 0 2.7.3 Contact Detail 3 Fax: 987654321
1 1
1

1.7.1 Type of Variation 1Minor - Prior Approval 1 to 20 1 1 1

3 PRODUCT INFORMATION 0 PR
OC
1.7.1.1 Variation Code 1:PA09 1 EE1
Drug 1 0 HUHS 1 1D
1.7.2 Type of Variation 2Nothing Further Human Drug, Branded Food 0
3.1 Product Ca Device 1 1
3.2 Product/Brand Name 3.2.1 Generic Name 1 1
1 1 PR1
OC
1 EE1
0 1 1 1D
IVERCOL PARACETAMOL
1 None Source None 0
5.1.1 Type of Establishment: 0 1

3.2.2 EDL? No 3.2.3 Samples?: No

3.3.0 Drug Classification: OTC 1 1
1 3.3.1 Dosage Strength: 500mg
3.3.2 Dosage Form: Tablet
1 1 3.3.3 Pharma Category: Analgesic 1 1
Type of Amendment: Other Amendments 0 3.4.0 Packaging: Blister Packaging 1 1
Source: Add/ Delete FAL 0 License to Operate FAL 0 3.4.1 Presentation/GPIN/GTIN: 500mg(1098765432) 1 1
Source: Change of B FAL 0 Reclassification FAL 0 3.4.2 Storage Condition: NMT 30 degree Celcius 0 1 0 1
Change of Importer/ FAL 0 0 Change of DistributorFAL 0 0 3.4.3 Shelf-life: 3 years Mobile: 1 1 01 1
Product Registration TRU 1 Finished Product FAL 0 3.4.4 Sugg. Retail Price Php 5.00
None 0 None 0
License to Operate FAL 0 Raw Material FAL 0
1 Free Sale, Certificate FAL 0 1 1 1
Pharmaceutical Produc FAL 0
Export Certificate FAL 0 0
Additional ProductionFAL 0 0 1 1 1
ORDER OF PAYMENT 1
Amount Due: 510
Fee : 500 1 1
Legal Research Fee : 10 1 1
Surcharge : 0 1 1
OR Number : 0 1 0 1
Date Paid: 01 1 01 1
Computation Valid Until: 45359
None 0 None 0
6 APPLICANT INFORMATION
1 1

The undersigned attest to have provided true and complete information in this form, and to provide complete requirements
at the time of submission. The undersigned agree to strict compliance with the rules and regulations of the Food and Drug 1 1
Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage Practice (GDSP), Good
Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree to grant authority to the
FDA to verify the truthfulness of the information provided with this application.

6.1 APPROVING AUTHORITY

Latest photo of applicant
6.1.2 Designation:
6.1.3 Tax ID Number:
6.1.4.0 Type of Gov't ID:
6.1.4.1 ID Number:
6.1.4.2 Date Expiry:
6.2 APPLICANT
Latest photo of applicant
6.2.2 Designation:
6.2.3 Tax ID Number:
6.2.4.0 Type of Gov't ID:
6.2.4.1 ID Number:
6.2.4.2 Date Expiry:
6.1.5 Mailing Address
Signature
6.1.1.0 Family Na Apalla
Minante 1, Cauayan City, Isabela
6.1.1.1 First NameChabelita 6.1.6.0 E-mail Address:
ivermedicarelab@gmail.com
6.1.1.2 Middle N D. 6.1.6.1 Contact Detail 1
Owner/ General Manager/ President Mobile:
456-579-123 6.1.6.2 Contact Detail 2
Professional Regulatory Commission Landline:
789-123 6.1.6.3 Contact Detail 3
44965 Fax:
6.2.5 Mailing Address
Signature
6.2.2.0 Family Na Apalla
Minante 1, Cauayan City, Isabela
6.2.2.1 First NameChabelita 6.2.6.0 E-mail Address:
ivermedicarelab@gmail.com
6.2.2.2 Middle N D. 6.2.6.1 Contact Detail 1
Company Pharmacist Mobile:
456-579-123 6.2.6.2 Contact Detail 2
Social Security System Landline:
789-123 6.2.6.3 Contact Detail 3
44965 Fax:
1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
9222234567 1 1
6421234
1 1
987654321 1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
1 1
9222234567 1 1
1 1
6421234 1 1
0 1 0 1
987654321 01 1 01 1

Page 7 of 15 581468947.xlsx 03/10/2022 01:19:47

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 8 of 15 581468947.xlsx 03/10/2022 01:19:47

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 9 of 15 581468947.xlsx 03/10/2022 01:19:47

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 10 of 15 581468947.xlsx 03/10/2022 01:19:47

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