1 Integrated Application Form.xlsx

Email WorksheetSUBJECT:

BODY:

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

For Drug Registration (excluding amendments and compliances):For Non-Drug Registration (excluding amendments and compliances):

For Licensing (exclusing amendments and compliances):For All Other Applications:

Application Process Overview

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.

Mercury Drug#XIIMPORTANT

Printing 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.


READ THIS PAGE CAREFULLY.

BEGIN:LTO;CDRR;Mercury Drug#XI#Retailer#CDRR-RXI-DS-2122;ARN#0#0#1#0#1####Mercury Drug- Davao City Abreeza Mall;3000;30;0;3030:END

Provide information only when asked for.

Printing Instructions

pages 1 and 4.pages 1 and 3.pages 1 and 2.page 1 only.


READ THIS PAGE CAREFULLY.Provide information only when asked for.

APPLICATION FORM

Document Tracking Number APPLICATION FORM STATUSGENERAL INFORMATION:

ESTABLISHMENT INFORMATION:Description (Optional): PRODUCT INFORMATION:Mercury Drug- Davao City Abreeza Mall SUPPORTING INFORMATION:1 GENERAL INFORMATION PROCEED SOURCES & CLIENTS:

1.1 Product Center:Drug APPLICANT INFORMATION:ORDER OF PAYMENT

1.2 Authorization:License to Operate Amount Due: Php 3,030.00 Fee : Php 3,000.00

1.3 Type:Renewal Legal Research Fee : Php 30.00 Surcharge : Php -

1.4 Primary Activity: Retailer OR Number :Date Paid:

Computation Valid Until: 30 June, 2016This form was last edited on 29 January 2016, 11:26 AM.

CDRR-RXI-DS-2122 PROCEED1.5.1 Expiry Date: 30-Jun-16

Your License will expire in 69 days.

No

AUTOMATIC RENEWAL

This is the application form. Without the appropriate petition or declaration form, this application may be rejected.

1.5 Current License Number:

1.7 Are there amendments or variations with your current authorization?

0717033AApril 13, 2016

2 ESTABLISHMENT INFORMATION PROCEED2.1 Name of Establishment

Mercury Drug

2.3 Tax Identification Number: 000-388-474-6322.4 Office Address 2.5.1 Region: XI

Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao City

2.7.0 E-mail Address: [email protected] Contact Detail 1 Landline: 082-285-07872.7.2 Contact Detail 2 Landline: 082-285-07872.7.3 Contact Detail 3 Landline: 082-285-0787

PROCEED

License to Operate

This is the petition form for establishment licensing by the Food and Drug Administration of the Philippines.

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 a PRC registered professional (if applicable) or authorized personnel;

III. The approved and valid License to Operate shall be displayed in a conspicuous place of the establishment;

VI. If applying for automatic renewal:

a. Have filed the application, and have paid the complete & appropriate renewal fee before expiry date;

We categorically declare that all data and information submitted in connection with this application as well as other submissions in the future including amendments, are true, correct, and reflect the total information available.

II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will not in any way be connected with any other FDA-regulated establishment (if applicable);

IV. To change the business name of the establishment and/or brand name of products in the event that there is a similar or same name registered with the Food and Drug Administration, or if the FDA rules later that it is misleading;

V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy and, any discrepancy, prejudicial contents or willful misrepresentation on any of the data therein shall be a ground for disapproval of application and/or the filing of legal action against the undersigned and/or the company;

B. That there are no changes or variations in the establishment since the last renewal of LTO specifically but not limited to change of location, change of ownership, change of business name, change of registered pharmacist, change in warehouse site, additional supplier and product lines, change in activity, change in key personnel;

VII. The products we manufacture, distribute and/or sell are registered or to be registered with FDA prior to distribution or sale, and that we assume primary responsibility and/or stewardship over the product in case of liability, adverse events, and/or other public health & safety issues;

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized representatives at any reasonable time and undertake to respond and cooperate fully with the FDA with regard to any subsequent post-marketing activity;

IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address, business name, ownership, or any other circumstances in relation to the approval of this application is a ground for revocation of the License to Operate;

WAIVER

ACKNOWLEDGEMENTSUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20________ at ______________________________

_______________________________________________________, Philippines, personally appeared the following :

Name and Signature Identification Number

1) Laida Gonzalvo Fallorina

2) Michelle Yu Monday

Doc. No. : _____________________________

Page No. : ____________________________

Book No. : ____________________________


X. Any violation of the above provisions and rules and regulations will automatically be subject to the SUSPENSION/ CANCELLATION/ REVOCATION of the License to Operate.

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other allied laws and their implementing rules and regulations.

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties and responsibilities among others, and prays that this application for License to Operate be granted after compliance with the Food and Drug Administration’s requirements.

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 .

Social Security System:09-0920-7551

Professional Regulatory Commission:49632

Known to me and to me known to be the same persons who execute the application form and this petition 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.

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;

APPLICATION FORM 5 SOURCES & CLIENTS

APPLICATION FORM STATUSGENERAL INFORMATION: PROCEED

ESTABLISHMENT INFORMATION: PROCEEDPRODUCT INFORMATION: PROCEED

SUPPORTING INFORMATION: PROCEEDSOURCES & CLIENTS: PROCEED

APPLICANT INFORMATION: PROCEEDORDER OF PAYMENT

Php 3,030.00 Php 3,000.00 Php 30.00 Php -

30 June, 2016This form was last edited on 29 January 2016, 11:26 AM.


0717033AApril 13, 2016

6 APPLICANT INFORMATION

6.1 APPROVING AUTHORITY

Latest photo of applicant

Signature

Fallorina

Laida

Gonzalvo

6.1.2 Designation: Owner/ General Manager/ President6.1.3 Tax ID Number: 134-769-3176.1.4.0 Type of Gov't ID: Social Security System6.1.4.1 ID Number: 09-0920-75516.1.4.2 Date Expiry: N/A6.2 APPLICANT


Signature

Monday

Michelle

Yu

6.2.2 Designation: Company Pharmacist

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 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.

6.1.1.0 Family Name:6.1.1.1 First Name(s):6.1.1.2 Middle Name:

6.2.2.0 Family Name:6.2.2.1 First Name(s):6.2.2.2 Middle Name:

6.2.3 Tax ID Number: 229-326-6346.2.4.0 Type of Gov't ID: Professional Regulatory Commission6.2.4.1 ID Number: 496326.2.4.2 Date Expiry: 29-Jun-16


PETITION

I/we am/are duly authorized to affirm the following declaration on behalf of the Company: Mercury Drug





We categorically declare that all data and information submitted in connection with this application as well as other submissions in the future including amendments, are true, correct, and reflect the total information available.

II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will not in any way be connected with any

IV. To change the business name of the establishment and/or brand name of products in the event that there is a similar or same name registered with the Food and

V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy and, any discrepancy, prejudicial contents or willful misrepresentation on any of the data therein shall be a ground for disapproval of application and/or the filing of legal action against the undersigned and/or the

B. That there are no changes or variations in the establishment since the last renewal of LTO specifically but not limited to change of location, change of ownership, change of business name, change of registered pharmacist, change in warehouse site, additional supplier and product lines, change in activity, change in key

VII. The products we manufacture, distribute and/or sell are registered or to be registered with FDA prior to distribution or sale, and that we assume primary responsibility and/or stewardship over the product in case of liability, adverse events, and/or other public health & safety issues;

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized representatives at any reasonable time and undertake to respond and cooperate fully with the FDA with regard to any subsequent post-marketing activity;


WAIVER



Identification Number Expiry Date of ID Place Issued

N/A______________________________

29-Jun-16Davao City

X. Any violation of the above provisions and rules and regulations will automatically be subject to the SUSPENSION/ CANCELLATION/ REVOCATION of the License to

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other allied laws and their implementing rules and regulations.

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties and responsibilities among others, and prays that this application for License to Operate be granted after compliance with the Food and Drug Administration’s requirements.

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 .

Social Security System:09-0920-7551

Professional Regulatory Commission:49632

Known to me and to me known to be the same persons who execute the application form and this petition 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.

CLOPIDOGREL (as BISULFATE)Off-white to beige, semi biconvex film-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 geometry properties among others, as applicable; Indicate if appropriate microbiological cultures present in the product

CLOPIDOGREL (as BISULFATE)Off-white to beige, semi biconvex film-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 geometry properties among others, as applicable; Indicate if appropriate microbiological cultures present in the product

CLOPIDOGREL (AS BISULFATE) NINBO BEITONG IMP. & EXP. CO. LTD., INDIA KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA2) 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;

PROCEED

6 APPLICANT INFORMATION PROCEED

6.1 APPROVING AUTHORITYSignature 6.1.5 Mailing Address

Fallorina

Laida 6.1.6.0 E-mail Address:

[email protected] Contact Detail 1

Owner/ General Manager/ President Landline:082-285-0787134-769-317 6.1.6.2 Contact Detail 2Social Security System Landline:082-285-078709-0920-7551 6.1.6.3 Contact Detail 3N/A Landline:082-285-0787

6.2 APPLICANTSignature 6.2.5 Mailing Address

Monday

Michelle 6.2.6.0 E-mail Address:

[email protected] Contact Detail 1

Company Pharmacist Landline:082-285-0787




229-326-634 6.2.6.2 Contact Detail 2Professional Regulatory Commission Landline:082-285-078749632 6.2.6.3 Contact Detail 329-Jun-16 Landline:082-285-0787


PETITION

Mercury Drug





We categorically declare that all data and information submitted in connection with this application as well as other submissions in the future including

II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will not in any way be connected with any

IV. To change the business name of the establishment and/or brand name of products in the event that there is a similar or same name registered with the Food and

V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy and, any discrepancy, prejudicial contents or willful misrepresentation on any of the data therein shall be a ground for disapproval of application and/or the filing of legal action against the undersigned and/or the

B. That there are no changes or variations in the establishment since the last renewal of LTO specifically but not limited to change of location, change of ownership, change of business name, change of registered pharmacist, change in warehouse site, additional supplier and product lines, change in activity, change in key

VII. The products we manufacture, distribute and/or sell are registered or to be registered with FDA prior to distribution or sale, and that we assume primary

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized representatives at any reasonable time and

IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address, business name, ownership, or any other

WAIVER



Place Issued

______________________________

Davao City

X. Any violation of the above provisions and rules and regulations will automatically be subject to the SUSPENSION/ CANCELLATION/ REVOCATION of the License to

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise known as the Food and Drug

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties and responsibilities among others, and prays that this

I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THROUGH BOTH GOVERNMENT AND PRIVATE

Known to me and to me known to be the same persons who execute the application form and this petition form, and they acknowledged to me that the same is their

Provide in this space a description of the product in terms of rheology, thermal, and geometry properties among others, as

microbiological cultures present in the

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

KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA2) 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;

Department of Health Food and Drug Administration

APPLICATION FORM

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APPLICATION FORM STATUS:GENERAL INFORMATION: PRO 1 0 1 0 0 0 0 SOURCES & CLIENTS: PRO 1

ESTABLISHMENT INFORMATION: PRO 1 1 Document Tracking NumberPRODUCT INFORMATION: PRO 1 0 0 0 1 0

0SUPPORTING INFORMATION: PRO 1 1 0 0 0 0APPLICANT INFORMATION: PRO 1 1 1 Description (Optional):

PAYMENT INFORMATION: 1 Mercury Drug- Davao City Abreeza MallGENERAL INFORMATION 2 ESTABLISHMENT INFORMATION

1.1 Product Center: Drug 1.4 Primary Activity: Retailer

1.2 Authorization: License to Operate2.1 Name of Establishment

Mercury Drug1.3 Type: Renewal 1

2.3 Tax Identification Number:2.4 Office Address

1.5 Current License Number: CDRR-RXI-DS-2122 Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao City1.5.1 Expiry Date: 30-Jun-2016

Your License will expire in 69 days. 1

1131-Dec-1899

2.7.0 E-mail Address: [email protected] Contact Detail 1 Landline:

1No

2.7.2 Contact Detail 2 Landline:0 2.7.3 Contact Detail 3 Landline:

AUTOMATIC RENEWAL

0

1

0 0

1

1 00

1

1

000

01 0

Type of Amendment: Other Amendments 0 0Source: Add/ Delete FAL 0 License to Operate FAL 0 0

1.7 Are there amendments or variations with your current authorization?


APPLICATION FORM

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Source: Change of BuFAL 0 Reclassification FAL 0 0Change of Importer/ DFAL 0 0 Activity: Additional FAL 0 0 0Product Registration FAL 0 Finished Product FAL 0 Php - License to Operate FAL 0 Raw Material FAL 0

0 Free Sale, Certificate FAL 0Pharmaceutical ProductFAL 0Export Certificate FAL 0 0

1Product Line FAL 0 0ORDER OF PAYMENTAmount Due: 3030Fee : 3000Legal Research Fee : 30Surcharge : 0OR Number :Date Paid:Computation Valid Until: 425516 APPLICANT INFORMATION



Signature

6.1.5 Mailing Address

Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao 6.1.1.0 Family Na Fallorina

6.1.1.1 First Name(Laida 6.1.6.0 E-mail Address:

6.1.1.2 Middle Na [email protected] Contact Detail 1

6.1.2 Designation: Owner/ General Manager/ President Landline:6.1.3 Tax ID Number: 134-769-317 6.1.6.2 Contact Detail 26.1.4.0 Type of Gov't ID: Social Security System Landline:6.1.4.1 ID Number: 09-0920-7551 6.1.6.3 Contact Detail 36.1.4.2 Date Expiry: N/A Landline:6.2 APPLICANT


Signature


Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao 6.2.2.0 Family Na Monday

6.2.2.1 First Name(Michelle 6.2.6.0 E-mail Address:




APPLICATION FORM

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Latest photo of applicant 6.2.2.2 Middle Na [email protected] Contact Detail 1

6.2.2 Designation: Company Pharmacist Landline:6.2.3 Tax ID Number: 229-326-634 6.2.6.2 Contact Detail 26.2.4.0 Type of Gov't ID: Professional Regulatory Commission Landline:6.2.4.1 ID Number: 49632 6.2.6.3 Contact Detail 36.2.4.2 Date Expiry: 42550 Landline:


APPLICATION FORM

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License to Operate

This form is the second page of a two-page application form for licensing by the Food and Drug Administration of the Philippines.

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 professional (if applicable) or authorized personnel;

II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will not in any way be connected with any other FDA regulated establishment (if applicable);


IV. To change the business name of the establishment in the event that there is a similar or same name registered with the Food and Drug Administration or if it rules later that it is misleading;

V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy and, any discrepancy/ prejudicial contents or wilful misrepresentation on any of the data therein shall be a ground for disapproval of


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 last renewal of LTO specifically but not limited to change of location, change of ownership, change of business name, change of registered pharmacist, change

VII. The products we manufacture, distribute or sell are registered or to be registered with FDA prior to distribiution or selling;

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized representatives at any reasonable time and undertake to respond and cooperate fully with the FDA with regard to any subsequent post-ma

IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address, business name, ownership, or any other circumstances in relation to the approval of this application is a ground for delisting of the License to


APPLICATION FORM

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XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other allied laws and their implementing rules and regulations

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties and responsibilities among others, and prays that this application for License to Operate be granted after compliance with the Food and Drug Administrati

WAIVER

I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THE AUTHENTICITY OF ALL THE DOCUMENTS SUBMITTED FROM BOTH GOVERNMENT AND PRIVATE RESOURCES.

ACKNOWLEDGEMENT

SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20________ at ______________________________


Name and Signature

1) Fallorina Laida

2)

Known to me and to me known to be the same persons who execute the foregoing instrument consisting of 2 pages including the application form, and they acknowledged to me that the same is their free and voluntary act and deed. WITNESS MY HAND AND

Doc. No. : _____________________________

Page No. : ____________________________

Book No. : ____________________________


APPLICATION FORM

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Book No. : ____________________________

Series of : _____________________________


APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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01Document Tracking Number 1

01

1 1

1Mercury Drug- Davao City Abreeza Mall

Retailer12.1 Name of Establishment

Mercury Drug11

2.3 Tax Identification Number: 000-388-474-632

12.4 Office Address 2.5.1 RegioXI


11

1

11

1

[email protected]: 082-285-0787Landline: 082-285-0787

1Landline: 082-285-0787

1

11

11

Drug 0 HUHSFood 0 Device 1

1

0

111

None 0

1

10

00

1000 10 1


APPLICATION FORM

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0 0 10 0 1 1

Php - None 0

1 1

111

111

0 10 1 1

None 06 APPLICANT INFORMATION

1

1



Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao

11

0 10 1 1

None 0

6.1.6.0 E-mail Address: [email protected]

16.1.6.1 Contact Detail 1

082-285-07876.1.6.2 Contact Detail 2

1082-285-0787

6.1.6.3 Contact Detail 3082-285-0787 1

6.2 APPLICANT 16.2.5 Mailing Address 0 1

Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao

0 1 1

None 0

1

16.2.6.0 E-mail Address:


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 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


APPLICATION FORM

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[email protected]

16.2.6.1 Contact Detail 1

082-285-07876.2.6.2 Contact Detail 2 1

082-285-0787 16.2.6.3 Contact Detail 3 0 1

082-285-0787 0 1 1


APPLICATION FORM

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PETITION

I/we am/are duly authorized to affirm the following declaration on behalf of the Company: 1.5.1 Expiry Date:














APPLICATION FORM

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WAIVER


ACKNOWLEDGEMENT



Identification Number Date Issued Place Issued

_________________________ ___________ ______________________________

_________________________ ___________ ______________________________



APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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1111

1 1

1

1

1

1

1

1

1

1

1

11

1111

1 1

None 0

1

1

111


APPLICATION FORM

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0 10 1 1

None 0

1

1

111

0 10 1 1

None 0

1

1

111

0 10 1 1

None 0

1

1

111

0 10 1 1

None 0

1

1


APPLICATION FORM

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111

0 10 1 1


APPLICATION FORM

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PETITION

1.5.1 Expiry Date:














APPLICATION FORM

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WAIVER


ACKNOWLEDGEMENT



Place Issued

______________________________

______________________________



APPLICATION FORM

Page 67 of 80 315387420.xlsx 04/22/2016 07:52:33


APPLICATION FORM

Page 68 of 80 315387420.xlsx 04/22/2016 07:52:33


APPLICATION FORM

Page 69 of 80 315387420.xlsx 04/22/2016 07:52:33


APPLICATION FORM

Page 70 of 80 315387420.xlsx 04/22/2016 07:52:33


APPLICATION FORM

Page 71 of 80 315387420.xlsx 04/22/2016 07:52:33


APPLICATION FORM

Page 72 of 80 315387420.xlsx 04/22/2016 07:52:33

LTOGENERAL INFORMA COMPANY INFORMATION LTO INFORMATIONAPPLICANT INFORMATION

TIN

0 LTO ARN 1-1 1-1 ###

CPRGENERAL INFORMACOMPANY INFORMATION PRODUCT INFORMATIONDOC CENTAUTHAPPLApplAddrE-maiTIN ContLTO ValidBranGeneDosaClassEssenPharManu Add

0 CDRRLTO ARN MercXI-Abmd.c000-LandCDRR###1 0 0 0 0 0 1-1 1

CosmCCRR AdditPSZDrugCDRR ChangCIDFoodCFRR ChanCBNHousCCRR ShelfSLFMedicCDRR PCPRPCCIodizCFRR WareWRH

SourcSADSourSCN

LicenLTO ChanCBNNotifNTN ChangCKPProduCPR PackPDSPromPADClinicCTROtherOTH

InitiaINT 1ReneRNW 0AutoARNVariaVAR MajoLVMAmenAMD MinorLVPCompCOM MinorLVNRe-I REIReappRAPHome HSO OtheOTHSalesSPR FinisFIPDisc DSC Raw MRAWAmendAMJ ActivACTAmenAMN ProduPRLGenerGLE NothiNOFFree CFS ReclaRCLPharmPHPExporEXP MajoCVM

DOC TRACK NO

CENTER

AUTHORIZATION

APPLICATION TYPE

Name of Establishment

Plant

Address

Ofce

Address

Contact Details

Warehouse Address

Owner

LTO No

Validity

Date

Issued

Name

Identifcation No

Validity

Service Begun

Previou

s Employer

CDRR

Mercury Drug#XI

XI-Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao City

Landline:082-285-0787;Landline:082-285-0787;Landline:082-285-0787

000-388-474-632

Laida Gonzalvo Fallorina

CDRR-RXI-DS-2122

Laida Gonzalvo Fallorina-Owner/ General Manager/ President;Michelle Yu Monday-Company Pharmacist

Social Security System-09-0920-7551;Professional Regulatory Commission-49632

N/A;42550

BranBRN MinorCVP1ProviPPM MinorCVP2ExempCEX MinorCVNHACCPHCP PCPRCON

APPLICANT INFORMATION PAYMENT DETAILSFee LRF

1 ####### # 0

PRODUCT INFORMATIONTIN LTO ValidTrad AddTIN LTO ValidRepa AddTIN LTO ValidImpo AddTIN LTO ValidDistr

1 1 1-1 1 1 1 1-1 1 1 1 1-1 1 1 1 1-1

APPLICATION DETAILS

AMENDMENT 1

AMENDMENT 2

AMENDMENT 3

OTHERS

Date of Resignation

Company Classifcatio

n

Produc

t Category

Capital

TYPE

ADD

DELETE/CHANGE

TYPE

ADD

DELETE/CHANGE

TYPE

ADD

DELETE/CHANGE

Surcharge

Total

OR No.Ret

ailer

PAYMENT DETAILS

###

PRODUCT INFORMATIONAPPL

OTHER REQUEST AddTIN LTO ValidShelfStor PackSuggeNo. ExpirCPR VRegi RegisAmenAmenAmenCertiOthe

1 1 1 0 0 0 ## 0 #########ARN

Date

Issued

PAYMENT DETAILSFee LRF SurcTotalOR NDate Issued

# ####### ######

Documents

1 Integrated Application Form.xlsx