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 appropriately filled up, a green 'PROCEED' will be BODY: 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 Printing Instructions (not as an image or as an attachment). DON'T attach any (Please print the following p file to the email request. For Drug Registra For Non-Drug Registra For Licen
Application Process Overview
Mercury Drug#XI
BEGIN:LTO;CDRR;Mercury Drug#XI#Retailer#CDRR-RXI-DS2122;ARN#0#0#1#0#1####Mercury DrugDavao City Abreeza Mall;3000;30;0;3030:END
IMPORTANT READ THIS PAGE CAREFULLY. Provide information only when asked for.
rinting Instructions
Please print the following parts of the worksheet 'Form' if applicable) For Drug Registration (excluding amendments and compliances): pages 1 and 4. For Non-Drug Registration (excluding amendments and compliances): pages 1 and 3. For Licensing (exclusing amendments and compliances): pages 1 and 2. For All Other Applications: page 1 only.
PAGE . ormation only d for.
ages 1 and 4. ages 1 and 3. ages 1 and 2. age 1 only.
APPLICATION F
This is the application form. Witho appropriate petition or declaration application may be rejected.
APPLICATION FORM STATU
Document Tracking Number Description (Optional): Mercury Drug- Davao City Abreeza Mall
1 GENERAL INFORMATION
PROCEED
1.1 Product Center: Drug 1.2 Authorization: License to Operate 1.3 Type: Renewal 1.4 Primary Activity: Retailer
GENERAL INFORMATION: ESTABLISHMENT INFORMATION: PRODUCT INFORMATION: SUPPORTING INFORMATION: SOURCES & CLIENTS: APPLICANT INFORMATION:
ORDER OF PAYMENT Amount Due: Php
Fee : Php Legal Research Fee : Php Surcharge : Php OR Number : 0717033A Date Paid: April 13, 20
Computation Valid Until:
30 J
This form was last edited on 29 January 2016, 1
1.5 Current License CDRR-RXI-DS-2122 Number: 1.5.1 Expiry Date: 30-Jun-16
Your License will expire in 69 days.
1.7 Are there amendments or variations with your current authorization?
AUTOMATIC RENEWAL
No
PROCEED
2 ESTABLISHMENT INFORMATION PROCEED 2.1 Name of Establishment Mercury Drug
2.3 Tax Identification Number: 000-388-474-632 2.4 Office Address 2.5.1 Region: XI Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao City
2.7.0 2.7.1 2.7.2 2.7.3
E-mail Address: Contact Detail 1 Contact Detail 2 Contact Detail 3
[email protected]
Landline: Landline: Landline:
082-285-0787 082-285-0787 082-285-0787
PROCEED
License to Operate
This is the petition form for establishmen
We categorically declare that all data and information submitted in amendments, are true, correct, and reflect the total information availab
I/we am/are duly authorized to affirm the following declaration on b
I. The said establishment shall be open for business hours under the su
II. The pharmacist and other allied health professionals, upon and durin other FDA-regulated establishment (if applicable);
III. The approved and valid License to Operate shall be displayed in a co
IV. To change the business name of the establishment and/or brand nam Drug Administration, or if the FDA rules later that it is misleading;
V. The attached electronic copy of files/documents/information of the LT or willful misrepresentation on any of the data therein shall be a ground company; VI. If applying for automatic renewal:
a. Have filed the application, and have paid the complete & appropria
B. That there are no changes or variations in the establishment since change of business name, change of registered pharmacist, change in personnel;
VII. The products we manufacture, distribute and/or sell are registered o responsibility and/or stewardship over the product in case of liability, ad
VIII. The establishment whether for initial, renewal or automatic renewa undertake to respond and cooperate fully with the FDA with regard to an
IX. Non-compliance with the requirements and/or failure to give notice t circumstances in relation to the approval of this application is a ground f
IX. Non-compliance with the requirements and/or failure to give notice t circumstances in relation to the approval of this application is a ground f
X. Any violation of the above provisions and rules and regulations will a Operate.
XI. I/We make this declaration in full knowledge and awareness of Repu Administration Act of 2009, other allied laws and their implementing rul
WHEREFORE, the undersigned confirm the truth of our declaration and a application for License to Operate be granted after compliance with the
I HEREBY GRANT AUTHORITY TO THE FOOD AND D RESOURCES THE AUTHENTICITY
A
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day
_______________________________________________________, Philippines, pers Name and Signature
Socia
1) Laida Gonzalvo Fallorina 2) Michelle Yu Monday
Known to me and to me known to be the same persons who execute th free and voluntary act and deed. WITNESS MY HAND AND SEAL on the d Doc. No. : _____________________________ Page No. : ____________________________ Book No. : ____________________________
Book No. : ____________________________ Series of : _____________________________
CLOPIDOGREL (as BISULFATE)
CLOPIDOGREL (as BISULFATE)
CLOPIDOGREL (AS BISULFATE) 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;
ON FORM
m. Without the laration form, this d.
STATUS ATION: PROCEED ATION: PROCEED ATION: PROCEED ATION: PROCEED IENTS: PROCEED ATION: PROCEED
Php
hp hp hp
3,030.00
717033A ril 13, 2016
3,000.00 30.00 -
30 June, 2016
ry 2016, 11:26 AM.
5 SOURCES & CLIENTS
6 APPLICANT INFORMATION
The undersigned attest to have provided true and complete information in this fo requirements at the time of submission. The undersigned agree to strict complia Food and Drug Administration (FDA), including Good Manufacturing Practice (GM (GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). F authority to the FDA to verify the truthfulness of the information provided with th
6.1 APPROVING AUTHORITY Signature
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
6.1.1.0 Family Name: 6.1.1.1 First Name(s): 6.1.1.2 Middle Name:
Fallorina Laida Gonzalvo
Owner/ General Manager/ President 134-769-317 Social Security System 09-0920-7551 N/A Signature
Latest photo of applicant
6.2.2 Designation:
6.2.2.0 Family Name: 6.2.2.1 First Name(s): 6.2.2.2 Middle Name:
Monday Michelle Yu
Company Pharmacist
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:
229-326-634 Professional Regulatory Commission 49632 29-Jun-16
shment licensing by the Food and Drug Administration of the Philippines.
PETITION
ted in connection with this application as well as other submissions in th vailable.
n on behalf of the Company:
Mercury Drug
the supervision of a PRC registered professional (if applicable) or authorized
during employment in this establishment, is/are not and will not in any wa
in a conspicuous place of the establishment;
nd name of products in the event that there is a similar or same name regis
the LTO application are the exact duplicate of the hard copy and, any discr round for disapproval of application and/or the filing of legal action against
propriate renewal fee before expiry date;
since the last renewal of LTO specifically but not limited to change of locat ange in warehouse site, additional supplier and product lines, change in act
tered or to be registered with FDA prior to distribution or sale, and that we ity, adverse events, and/or other public health & safety issues;
enewal, is still subject to inspection by FDA’s authorized representatives at d to any subsequent post-marketing activity;
otice to the FDA of the change in business address, business name, owners ound for revocation of the License to Operate;
will automatically be subject to the SUSPENSION/ CANCELLATION/ REVOCA
Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise k ing rules and regulations.
and awareness of the foregoing duties and responsibilities among others, th the Food and Drug Administration’s requirements.
WAIVER
AND DRUG ADMINISTRATION TO VERIFY THROUGH BOTH GOVERNMENT AN NTICITY OF ALL THE INFORMATION AND DOCUMENTS SUBMITTED .
ACKNOWLEDGEMENT
__ day of _________________ 20________ at ______________________________
s, personally appeared the following : Identification Number
Expiry Date of ID
Social Security System:09-09207551
N/A
Professional Regulatory Commission:49632
29-Jun-16
___________
D
ute the application form and this petition form, and they acknowledged to n the date and place first above written.
Off-white to beige, semi biconvex filmcoated 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 geometry properties among others, as applicable; Indicate if appropriate microbiological cultures present in the
Off-white to beige, semi biconvex filmcoated 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 geometry properties among others, as applicable; Indicate if appropriate microbiological cultures present in the product
NINBO BEITONG IMP. & EXP. CO. LTD., INDIA 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;
KAMAGONG CHEMT 2) API Supplier, Ad 3) API Supplier, Ad 4) API Supplier, Ad 5) API Supplier, Ad 6) API Supplier, Ad 7) API Supplier, Ad 8) API Supplier, Ad 9) API Supplier, Ad
10) API Manufacturer, Address Address Address; 11) API Manufacturer, Address Address Address; 12) API Manufacturer, Address Address Address;
10) API Supplier, A 11) API Supplier, A 12) API Supplier, A
PROCEED
PROCEED
in this form, and to provide complete compliance with the rules and regulations of the tice (GMP), Good Distribution and Storage Practice e (GLP). Further, the undersigned agree to grant ed with this application.
nt
6.1.5 Mailing Address
Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao City
6.1.6.0 E-mail Address:
[email protected]
6.1.6.1 Contact Detail 1 Landline: 082-285-0787 6.1.6.2 Contact Detail 2 Landline: 082-285-0787 6.1.6.3 Contact Detail 3 Landline: 082-285-0787 6.2.5 Mailing Address Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao City
6.2.6.0 E-mail Address:
[email protected]
6.2.6.1 Contact Detail 1 Landline: 082-285-0787
on
6.2.6.2 Contact Detail 2 Landline: 082-285-0787 6.2.6.3 Contact Detail 3 Landline: 082-285-0787
nes.
s in the future including
horized personnel;
any way be connected with any
e registered with the Food and
y discrepancy, prejudicial contents gainst the undersigned and/or the
f location, change of ownership, in activity, change in key
at we assume primary
ves at any reasonable time and
ownership, or any other
EVOCATION of the License to
rwise known as the Food and Drug
thers, and prays that this
NT AND PRIVATE
__
Place Issued
_________________________ Davao City
ed to me that the same is their
the , and s
e
Use this space to explain how the lot code used on the product label is correctly interpreted
Use this space to explain how the lot code used on the product label is correctly interpreted
G CHEMTRADE CORP./SAN PEDRO LAGUNA plier, Address Address Address; plier, Address Address Address; plier, Address Address Address; plier, Address Address Address; plier, Address Address Address; plier, Address Address Address; plier, Address Address Address; plier, Address Address Address;
pplier, Address Address Address; pplier, Address Address Address; pplier, Address Address Address;
Department of Health Food and Drug Administration
APPLICATION FORM 1 0 1 0 0 0 0 SOURCES & CLIENTS:
APPLICATION FORM STATUS: GENERAL INFORMATION: PRO ESTABLISHMENT INFORMATION: PRO PRODUCT INFORMATION: PRO SUPPORTING INFORMATION: PRO APPLICANT INFORMATION: PRO PAYMENT INFORMATION: GENERAL INFORMATION
1 1 1 1 1
1.1 Product Center:
Drug
1.2 Authorization:
License to Operate
1 0 1 1
PRO 1
Document Tracking Number 0 0 1
0 0
1 0
0 0 Description (Optional): Mercury Drug- Davao City Abreeza Mall 2 ESTABLISHMENT INFORMATION 1.4 Primary Activity: 2.1 Name of Establishment
Retailer
Mercury Drug 1.3 Type:
Renewal 2.3 Tax Identification Number: 2.4 Office Address
1.5 Current License Number: 1.5.1 Expiry Date:
CDRR-RXI-DS-2122
Abreeza Mall, J.P. Laurel, Brgy. 20-B, Dav 30-Jun-2016
Your License will expire in 69 days. 1 31-Dec-1899 2.7.0 2.7.1 2.7.2 2.7.3
1 1.7 Are there amendments or variations with your No 0 current authorization?
E-mail Address: Contact Detail 1 Contact Detail 2 Contact Detail 3
md.cpag@mer Landline: Landline: Landline:
AUTOMATIC RENEWAL 0 1 0
0
1 0 1
0
0 0 0
1 1 Type of Amendment: Source: Add/ Delete FAL
Page 40 of 80
0
1 Other Amendments License to Operate
0 FAL 0
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Department of Health Food and Drug Administration Source: Change of BuFAL Change of Importer/ DFAL Product Registration FAL License to Operate FAL
0 0 0 0 0
0 APPLICATION FORM 0 0
FAL Reclassification 0 Activity: Additional FAL FAL Finished Product FAL Raw Material Free Sale, Certificate FAL Pharmaceutical Product FAL Export Certificate FAL FAL Product Line
ORDER OF PAYMENT Amount Due: Fee : Legal Research Fee : Surcharge : OR Number : Date Paid: Computation Valid Until: 6 APPLICANT INFORMATION
0 0 0 0 0 0
Php
0 0
3030 3000 30 0
This is the application form. Without the 42551 declaration form, this application may b
The undersigned attest to have provided true and complete information in this form, and to provide com the time of submission. The undersigned agree to strict compliance with the rules and regulations of the Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage Pract Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree to gran verify the truthfulness of the information provided with this application.
6.1 APPROVING AUTHORITY
6.1.5 Mailing Addr
Signature 6.1.1.0 Family Na Fallorina 6.1.1.1 First Name(Laida 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
6.1.1.2 Middle Na Gonzalvo Owner/ General Manager/ President 134-769-317 Social Security System 09-0920-7551 N/A
Abreeza Mall, J.P. L 6.1.6.0 E-mail Add md.cpag@mercury 6.1.6.1 Contact De Landline: 6.1.6.2 Contact De Landline: 6.1.6.3 Contact De Landline:
6.2.5 Mailing Addr
Signature 6.2.2.0 Family Na Monday 6.2.2.1 First Name(Michelle
Abreeza Mall, J.P. L 6.2.6.0 E-mail Add
Latest photo of applicant Page 41 of 80
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Department of Health Food and Drug Administration 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:
Page 42 of 80
APPLICATION FORM 6.2.2.2 Middle Na Yu Company Pharmacist 229-326-634 Professional Regulatory Commission
315387420.xlsx
md.cpag@mercury 6.2.6.1 Contact De Landline: 6.2.6.2 Contact De Landline: 49632 6.2.6.3 Contact De 42550 Landline:
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Department of Health Food and Drug Administration License to Operate
APPLICATION FORM
This form is the second page of a two-page application form for licensing by the Food and Drug Admi
PETITION
I/we am/are duly authorized to affirm the following declaration on behalf of the Company:
I. The said establishment shall be open for business hours under the supervision of PRC registered profe
II. The pharmacist and other allied health professionals, upon and during employment in this establishm
III. The approved and valid License to Operate shall be displayed in a conspicuous place of the establish
IV. To change the business name of the establishment in the event that there is a similar or same name
V. The attached electronic copy of files/documents/information of the LTO application are the exact dupli VI. If applying for automatic renewal: a. Have filed the application before expiry date; b. Have paid the renewal fee prior its expiry date;
c. That there are no unapproved changes or variations whatsoever in the establishment since the las
VII. The products we manufacture, distribute or sell are registered or to be registered with FDA prior to d
VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by
IX. Non-compliance with the requirements315387420.xlsx and/or failure to give notice to the FDA of the change in busin Page 43 of 80 04/22/2016 07:52:32
Department of Health Food and Drug Administration
APPLICATION FORM
IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in busin
X. Any violation of the above provisions and rules and regulations will automatically be subject to the SU
XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended b
WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties
WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THE AUTHENTICITY O ACKNOWLEDGEMENT
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20__ _______________________________________________________, Philippines, personally appeared the following : Name and Signature
1) Fallorina Laida
2)
Known to me and to me known to be the same persons who execute the foregoing instrument consistin
Doc. No. : _____________________________ Page No. : ____________________________ Book No. : ____________________________ Page 44 of 80
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APPLICATION FORM
Book No. : ____________________________
Series of : _____________________________
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APPLICATION FORM
1
0
0 1 1
1
1
za Mall 1
Retailer 1
1
1
000-388-474-632 2.5.1 RegioXI 1
0-B, Davao City 1 1 1 1 1 1
[email protected] e: 082-285-0787 e: 082-285-0787 e: 082-285-0787
1
1 1 1
1 1
Drug Food
0 0
1 1 1 1 1 1
HUHS Device
0
None
0 1
0
0 0
1 0 0 0 0
Page 51 of 80
1 1 1
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Department of Health Food and Drug Administration 0 0 Php
-
APPLICATION FORM00 1 None
1 1 0
1
1
1 1
1
hout the appropriate petition or n may be rejected.
1 1 1 1
0 01 None
1 0 1
de complete requirements at s of the Food and Drug ge Practice (GDSP), Good to grant authority to the FDA to
1
ng Address
1 1 1 1
0 01
all, J.P. Laurel, Brgy. 20-B, Davao mail Address: mercurydrug.com ntact Detail 1 082-285-0787 ntact Detail 2 082-285-0787 ntact Detail 3 082-285-0787
None
1 0 1
1
ng Address
1 1 1 1
0 01 None
1 0 1
all, J.P. Laurel, Brgy. 20-B, Davao mail Address:
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1
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mercurydrug.com ntact Detail 1 082-285-0787 ntact Detail 2 082-285-0787 ntact Detail 3 082-285-0787
Page 53 of 80
APPLICATION FORM
0 01
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1 1 1 1 1
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Department of Health Food and Drug Administration
APPLICATION FORM
ug Administration of the Philippines.
1.5.1 Expiry Date:
ed professional (if applicable) or authorized personnel;
ablishment, is/are not and will not in any way be connected with any other FDA regulated establishment (if a
stablishment;
e name registered with the Food and Drug Administration or if it rules later that it is misleading;
ct duplicate of the hard copy and, any discrepancy/ prejudicial contents or wilful misrepresentation on any o
e the last renewal of LTO specifically but not limited to change of location, change of ownership, change of bu
rior to distribiution or selling;
tion by FDA’s authorized representatives at any reasonable time and undertake to respond and cooperate fu
in business business name, ownership, or any other circumstances in relation to the approval of thi Page 54 address, of 80 315387420.xlsx 04/22/2016 07:52:33
Department of Health Food and Drug Administration
APPLICATION FORM
in business address, business name, ownership, or any other circumstances in relation to the approval of thi
o the SUSPENSION/ CANCELLATION/ REVOCATION of the License to Operate.
ended by Republic Act no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other a
g duties and responsibilities among others, and prays that this application for License to Operate be granted
TICITY OF ALL THE DOCUMENTS SUBMITTED FROM BOTH GOVERNMENT AND PRIVATE RESOURCES.
___ 20________ at ______________________________
owing : Identification Number
Date Issued
Place Issued
_________________________
___________
__________________
_________________________
___________
__________________
consisting of 2 pages including the application form, and they acknowledged to me that the same is their fre
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Department of Health Food and Drug Administration 1 APPLICATION FORM 1 1 1 1
1
1
1
1
1
1
1
1
1
1 1 1 1 1 1 1 1 None
1 0 1
1
1 1 1
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Department of Health Food and Drug Administration 0 1 APPLICATION FORM 01 1 None
0 1
1
1 1 1 1
0 01 None
1 0 1
1
1 1 1 1
0 01 None
1 0 1
1
1 1 1 1
0 01 None
1 0 1
1
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0 01
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APPLICATION FORM
hment (if applicable);
n on any of the data therein shall be a ground for disapproval of
hange of business name, change of registered pharmacist, change
ooperate fully with the FDA with regard to any subsequent post-ma
roval of this is a ground for delisting of the License to Page 65 application of 80 315387420.xlsx
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APPLICATION FORM
roval of this application is a ground for delisting of the License to
09, other allied laws and their implementing rules and regulations
be granted after compliance with the Food and Drug Administrati
S.
ssued
_______________________
_______________________
is their free and voluntary act and deed. WITNESS MY HAND AND
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OtheOTH Finis FIP Raw R MAW ActivACT ProduPRL NothiNOF ReclaRCL MajoCVM
BranBRN ProviPPM Exemp CEX HACCP HCP
MinorCVP1 MinorCVP2 MinorCVN PCPRCON
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TIN LTO ValidTrad AddTIN LTO ValidRepa AddTIN LTO ValidImpo AddTIN LTO ValidDistr
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1-1 1
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OTHER REQUEST APPL AddTIN LTO ValidShelfStor PackSugge No. ExpirCPR V Regi Regis Amen Amen Amen CertiOthe
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PAYMENT DETAILS Fee LRF SurcTotalOR NDate Issued
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