Republic of the Philippines Department of Health

BUREAU OF FOOD AND DRUGS M a n i l a

IN THE MATTER OF PETITION OF __________________________________ TO OPEN A FOOD ESTABLISHMENT MORE PARTICULARLY AS A : ( ) Manufacturer/Processor ( ) Repacker ( ) Importer/Trader ( ) Exporter --------------------------------------------------- P E T I T I O N E R COMES ON the undersigned petitioner unto the Bureau of Food and Drugs, Department of Health, Manila, respectfully alleges: FIRST - That the petitioner is of legal age, married/single, Filipino citizen and residing at,____________________________________________________________ SECOND - That he desires to open a food establishment, more particularly as a ____________________________________________ of food and drug products be located at _______________________________________ and shall be known as ________________________________________________, THIRD - That the said establishment with a capital / investment of Pph_____________ is owned by ________________________ with postal address, at_____________________________________________ and with Tel. No._______ FOURTH - That the petitioner hereby agrees to change the business name or corporate name of the establishment in the event that there is a similar or same name registered with the Bureau of Food and Drugs or if it rules later that it is misleading; WHEREFORE, the petitioner respectfully prays that he / she be granted License to Operate said establishment after inspection thereof and after compliance with the Bureau of Food and drugs requirements, rules and regulations, including but not limited to attached BFAD - ILD Form No. 6, which is made as an integral part of this Petition. Manila,Philippines,__________________________________________2009. Respectfully submitted: _____________________________ Printed Name of Petitioner _____________________________ Signature SUBSCRIBED AND SWORN to me this ___ day of ____________________ 2006. Affiant exhibited to me his / her Residence Certificate No. ________________ issued at _______________________________ on _______________, 2009 Doc. no. ________ Book No. _______ _________________________________ Page No. ________ Administering Officer Series of ________

INFORMATION SHEET (FOOD MANUFACTURING AND PROCESSING ESTABLISHMENT)

( ) New Establishment ( ) Presently Operating I. Name of Owner : ( ) Single Proprietorship ( ) Corporation ( ) Partnership ( ) Association II. Name of Establishment : III. (a) Address of the establishment _____________________________________________________________________________ _____________________________________________________________________________ (b) Postal Address if different from (a) __________________________________________ _____________________________________________________________________________ (c) Telephone Number (s)_____________________________________________________ IV. List of \food and Drugs Products to be manufactured / repacked and or / exported/ imported. V. List of Equipment and machinery (For Manufacturer and Repacker only) VI. If a license, state name, and address of licensing firm: Name: ________________________________________________________ Address: ______________________________________________________ VII. Source(s) of materials to be used: (a) Local ( ) Yes ( ) No (b) Imported ( ) Yes ( ) No Country of Origin____________________ (c) Imported finished product in bulk from the repackaging: ( ) Yes ( ) No Country of Origin: ______________ VIII. Personnel: List no. of technical employees and their scholastic attainment, who are directly in manufacturing / repackaging. IX. Are the products produced or manufactured for export ( ) Yes ( ) No. or for local domestic computation? ( ) Yes ( ) No. If for export state name of country to which it is exported I declared under oath that the foregoing statement composed of two (2) pages are true , correct and complete to the best of my knowledge and belief. Respectfully submitted: ________________________________ __________________ _________ Print Name and Sign above Title Date

Republic of the Philippines Department of Health

FOOD AND DRUG SERVICES CENTER FOR HEALTH DEVLOPMENT- CARAGA

Butuan City

Name of Establishment:_________________________________________________________ Addres_________________________________________________Tel.#:__________________ Name of Owner/Manager:________________________________________________________ CAPITAL BREAKDOWN: Equipment and supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . =____________________ Cost of the building/rental . . . . .. . . . . . . . . . . . . . . . . . . . . . . . = ____________________ Purchases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .= ___________________ Labels, cartoons, orders, etc. . . . . . . . . . . . . . . . . . . . . . . . . . . = ____________________ Salaries of the Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . = ____________________ Transport Utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . = ___________________ Cash on hand/Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . = ____________________ Total Capitalization . . . = _____________________

__________________________________________ Owner/Manager Name & Signature

REPUBLIC OF THE PHILIPPINES ) S.S. PROVINCE OF ______________________________) Subscribed and sworn to before me this ______ day of _____________________________ at ______________________________________________________________, Philippines. Affiant exhibited to me his/her Residence Certificate No. _____________________________, issued on ______________________________________________.

_____________________________ NOTARY PUBLIC

Doc. No. _________________ Page No. _________________

Book No. ________________ Series of _________________

Republic of the Philippines Department of Health

BUREAU OF FOOD AND DRUGS Alabang Muntinlupa

Metro Manila

INSPECTION CHECKLIST FOR FOOD ESTABLISHMENT

Name of Food Inspectors: 1 ______________________________________________________ 2______________________________________________________ Period of Inspection: Time ________ to _______ Day _____ Month ___________ Year ______ Persons Interviewed: 1. _____________________________ Position _____________________ 2. _____________________________ Position ____________________

P A R T - I

1. Name of Establishment: _______________________________________________________ Address: ________________________________________________ Tel.#: _____________ 2. Name of Owner/President of Corporation: _________________________________________ 3. License to Operate Number _____________________ Issued On: ______________________

Day Month Year Date of Last Renewal: _________________________ Day Month Year 4. Capital Invested: ______________________________ 5. Number of Personnel: Educational Attainment a. Production ____________________________ _________________________________ b. Laboratory ____________________________ ________________________________ 6. Production Manufactured: Name of Products Brand Name 7. Product Flow Chart attached Yes ( ) No ( ) 8. Organizational Chart attached Yes ( ) No ( ) 9. Quality Control Chart Procedure attached Yes ( ) No ( ) 10. List of Production equipment attached Yes ( ) No ( ) 11. List of Quality Control Facilities & Equipment Yes ( ) No ( ) 12. List of Name & Address of the raw supplier attached Yes ( ) No ( ) 13. Detail Description of Manufacturing Processes attached Yes ( ) No ( )

14. Quality Control Enforced in the Working Area attached Yes ( ) No ( ) 15. Volume of Production per product line per 8-hours shift: 16. Areas:

1. Total Land Area: _________________________ 2. Total Covered Area: ______________________

Interviewed by: Received by: ___________________________________ __________________________________ FDRO Inspector FDRO Inspector

CHECKLIST /REQUIREMENTS FOR REGISTRATION OF FOOD PRODUCTS

A. Letter of application from manufacturer/exporter/importer B. Valid License to Operate (LTO) C. Certificate of brand name clearance from BFAD D. Product information

a. List of ingredients in decreasing order or proportion b. Amount and technical specification of ingredients/additives used. c. Certificate from flavor supplier that the flavor components are recognized as safe

and suitable for human consumption either by the US Flavor Extract Manufacturer’s Association, US Food and Drug Administration, International Organization of Flavor Industry or other reputable Agency.

d. Physical description and specifications of the finished product.

E. Samples of the product and specifications of the finished product. (See attached list of minimum product samples)

F. Labels & labelling materials to be used for the product. G. Certificate of analysis. (Include analytical methods used) H. Method of manufacturer, packing and quality control. I. Stability data in support of declared Expiry date. J. Certificate of agreement between the foreign manufacturer/distributor and the

importer/local distributor. K. Government certificate of clearance and free sale of the product from the responsible

Government authority in the country of origin and duly authenticated by the Philippine consulate abroad.

L. Evidence of registration for payment. (change slip/Official Receipt)

INITIAL REGISTRATION: A. For Imported Products:

A. Exclusive distributor (source: direct from manufacturer) Requirements: Nos. 1,2,4,5,6,7,8,9,10,11,12

B. Non-Exclusive (No currently marketed similar products) Requirements: Nos. 1,2,4,5,6,10,11,12

C. Non-Exclusive (with currently marketed similar products) Requirements: Nos. 1,2,5,6,10,11,12

B. For Locally Manufactured products Requirements: Nos. 1,2,3,4,5,6,7,8,9,12 RENEWAL REGISTRATION (For all products):

A. Letter of application from the manufacturer/exporter/importer. B. Certificate of product Registration (CPR) of the previous year. C. Labels and labelling materials used for the products. D. Samples of the product in its commercial presentation. E. Renewal Registration Fee. F. Valid License to operate (LTO) G. Technical Specification of the Finish Product.

Submit in a transparent sealable plastic bag together with the samples. (For inquiry ask Product Services division, FOOD Section tel. # 842-45-38

BFAD-RDIFORM6-AEffective October 1, 1994

Republic of the Philippines

DEPARTMENT OF HEALTH BUREAU OF FOOD AND DRUGS Civic Drive, Filinvest Corporate City

Alabang, Muntinlupa City IN THE MATTER OF PETITION ______________________________________________________________ TO OPEN A DRUG/COSMETIC /MEDICAL DEVICE ESTABLISHMENT MORE PARTICULARY AS A: ( ) Retail Drugstore ( ) Hospital Pharmacy ( ) Retail Outlet for Non-Prescription Drugs ( ) Drug Distributor (Importer, Exporter, Wholesaler) ( ) Medical Device Distributor ( Importer, Exporter, Wholesaler) ( ) Cosmetic Distributor (Importer, Exporter, Wholesaler) ( ) Drug Manufacturer xx_____________________________________________xx

P E T I T I O N Comes now THE UNDERSIGNED PETITIONER UNTO THE Bureau of Food and Drugs, Department of Health, Manila, respectfully alleges; FIRST – That the petitioner is of legal age, married/single, Filipino citizen and residing at ______________________________________________________________. SECOND – That the petitioner desires to open a drug/cosmetic & medical device establishments more particularly ____________ to be located at __________________________ and shall be known as _________________________________________. THIRD – That the said establishment shall be open for business from ________A.M. to ________P.M. and shall be under the personal supervision of __________________________________________, a duly registered pharmacist with Certificate of Registration No. ______________________ issued on _______________________________. FOURTH – That _______________________________________ is the owner of said establishment with postal address at ___________________________________________________. FIFTH – That the amount of capital invested for said establishment is ___________________. SIXTH – That the petitioner hereby agrees to change the business name of the establishment in the event that there is a similar or same registered with the Bureau of food and Drugs or if it rules later it is misleading. WHEREFORE, the petitioner respectfully prays that she/he granted License to Operate a drug/cosmetic & medical device establishment after inspection therefore and after compliance with the Bureau of Food and Drugs requirements rules and regulations. Butuan City, Philippines ________________________________________________________. The undersigned, as owner of the ____________________________________________ Establishment, hereby declares under oath Printed Name of Pharmacist That he conforms to the declaration of the ___________________________________________ petitioner pharmacist, Signature Res. Cert. #:______________________________ _____________________________________ Issued on __________________________________ Owner Name and Signature at ________________________________________ Address: _____________________________ PTR #:____________________________________ Res. Cert. #: __________________________ Issued on__________________________________ Issued on_____________________________ at ______________________________________ At __________________________________ Telephone #:________________________________ Tel. #: ____________________________

SUBCRIBED AND SWORN to before me this __________ day of ______________________200____, affiant exhibit to me his/their Residence Certificate, the date of which are indicated below his/their respective name(s) on page one hereof.

_________________________________ Administering Officer

Doc. No. _________________ Page No. _________________ Book No. ________________ Affix P15.00 documentary stamp Series of _________________ INSTRUCTIONS:

1. For single proprietorship, attached Certificate of Registration from the Bureau Of domestic Trade, for corporation, partnership or other jurisdicial person, attached Certificate of Registration with the Securities & Exchange commission, together with a copy of Article of incorporation and By-laws. If the applicant is an alien, the petition must be accompanied by an authenticated copy of the Certificate of alien Registration.

2. All drugs and cosmetic products, prior to their introduction into the domestic commerce, must first

be registered with BFAD. 3. For other requirement, consult any BFAD License Examination or Inspector.

AFFIDAVIT OF UNDERTAKING

I, ______________________________________________________________________________ (Family Name, First Name, Maiden Middle) Owner/Pharmacist with PRC Registration Number: __________________________ Issued on _______________________ PTR No.: _________________________ Issued on _______________________ Of legal age, single/married and a resident of ___________________________________________ ________________________________________________________________________________ (Permanent Home Address) and owner/pharmacist of ____________________________________________________________ (Name of Company) located at ________________________________________________________________________ (Address of Company) after having been sworn in accordance with law, hereby declare:

1. that I am fully aware of the provision of Pharmacy Law, the Foods, Drugs, Devices and Cosmetic Act, the Generics Act of 1988 and that I am aware of the specific requirements that the operation of ____________________________________ shall be under my IMMEDIATE AND PERSONAL SUPERVISION with business hours being from ________________ AM to _______________ PM;

2. that I agree to change the business name if there is already a validly registered name similar to

business name;

3. that I shall display the approved License to Operate in a conspicuous place of my establishment;

4. that I shall notify BFAD in case of any change(s) in the circumstances of our application for a license to operate, including but not limited to change(s) of location, change of pharmacist-in-charge and change in drug products;

5. and that I, the pharmacist-in-charge, am not and will not be in any way be connected with any

drug or similar establishment/outlet;

WITHNESS WHEREOF, I hereunto affix my signature this ___ day of ________, 2009

_______________________________________ (Signature of Affiant)

Residence Cert. No. ______________________ Issued on:_______________________________ At _____________________________________

SUBSCRIBED AND SWORN TO ME THIS _______ day of __________________, 2009 at ____________________________________________________.

____________________________________ NOTARY PUBLIC Until December 31, 200______ Doc. no. ________ Book No. _______ Page No. ________ Series of ________

JOINT AFFIDAVIT OF UNDERTAKING

____________________________________PHARMACIST - IN - CHARGE with PRC Registration No.______________________ issued on____________________________________ PTR No.____________________________________ of legal age, single / married, and a resident of _________________________________________ and _____________________________________________________owner of

___________________________________________________________________________ (drug establishment)

located at ____________________________________________________________________ of legal age and a resident of _____________________________________________________ after having been sworn in accordance with laws, hereby declare;

1) That we are fully aware of the provisions of the Pharmacy Law, the Foods, Drugs and Devices And Cosmetics Act, the Generics Act of 1980 and that we are aware of the specific requirements that the operation of______________________________________ shall be under the IMMEDIATE AND PERSONAL SUPERVISION OF the Pharmacist-in-charge, the business hours being from _______A..M. to ______ P.M.;

2) That we agree to change the business name if there is already validly registered name similar

to our business name; 3) That we shall display our approved License to Operate in a conspicuous place of our establishment;

3) And that we shall notify BFAD in case of any change(s) in the circumstances of our application for a License to Operate, were specifically including but not limited to change(s) of location, change of pharmacist-in-charge; an change in drug products.

We execute this Joint Affidavit of Undertaking of confirm the truth of our declaration and our awareness of the foregoing duties and responsibilities among others. WITNESS HEREOF, we hereunto affix our signatures this ______ day of _______________, 2004. ___________________________________ _______________________________________ Owner’s Name & Signature Pharmacist Name & Signature Res. Cert. No.________________________ Res. Cert. No.__________________________ Issued on. ___________________________ Issued on _____________________________ at __________________________________ at ___________________________________ Subscribed and sworn to me before this _________ day of ___________ at_______________ _____________________________________. ______________________________________ Notary Public

Affix Php15.00 documentary stamp

Republic of the Philippines Department of Health

BUREAU OF FOOD AND DRUGS CENTER FOR HEALTH DEVELOPMENT-CARAGA

Butuan City

P H A R M A C I S T’S A F F I D A V I T

TO WHOM IT MAY CONCERN :

THIS IS TO CERTIFY THAT ________________________________________________________________ (BOARD REGISTERED NAME)

a duly registered pharmacist with Registration Certificate No. ___________issued on ____________, 200__ with Privilege Tax Receipt No. ________________(PTR) dated _______________, 200__ is the pharmacist –in- charge of ______________________________________located at _______________________________ ________________________________________________ with office hours from _____ A.M. ______P.M. (Attached photocopy of Certificate of registration and 2x2 latest picture) This certification is further authenticated by the above mentioned pharmacist with signature appears below.

____________________________________ ________________________________________

Date Printed Name of Pharmacist ____________________________________ _________________________________________

Printed Name of Owner Signature _____________________________________ _________________________________________

Signature Address _______________________________ Res. Cert. No. ________________________ Address Issued at ___________________________

on ___________________________ Owner : ____________________________________ PTR No. ____________________________ Address : ___________________________________ Issued at ____________________________ Res. Cert. No. ___________________ on ___________________________ Issued at _______________________ Tel. No. ____________________________ on _______________________ Tel. No. ________________________ SUBSCRIBED AND SWORN TO BEFORE ME THIS_____ day of ___________, 200__ Exhibited this/their Residence Certificate, the date of which are indicated below his/her respective name on page one hereof. Doc. No. ________________________ _ ___________________________________ Page No. ________________________ NOTARY PUBLIC Book No. _______________________ Series No. _______________________

Ρ 15.00 Documentary Stamps

Note: This certification is valid until a written notification from either one of the above

Signatories of any change of pharmacist shall have been filed and duly acknowledge by this office. In case of any change of pharmacist : This replace ________________________________________ with, Registration Certificate No. ____________ issued on __________________, 2000 who Resigned on _____________________________, 200____.

_______________________________________

OWNER

JOINT AFFIDAVIT OF UNDERTAKING

____________________________________PHARMACIST - IN - CHARGE with PRC Registration No.______________________ issued on____________________________________ PTR No.____________________________________ of legal age, single / married, and a resident of _________________________________________ and _____________________________________________________owner of

___________________________________________________________________________ (drug establishment)

located at ____________________________________________________________________ of legal age and a resident of _____________________________________________________ after having been sworn in accordance with laws, hereby declare;

1) That we are fully aware of the provisions of the Pharmacy Law, the Foods, Drugs and Devices And Cosmetics Act, the Generics Act of 1980 and that we are aware of the specific requirements that the operation of______________________________________ shall be under the IMMEDIATE AND PERSONAL SUPERVISION OF the Pharmacist-in-charge, the business hours being from _______A..M. to ______ P.M.;

2) That we agree to change the business name if there is already validly registered name similar

to our business name; 3) That we shall display our approved License to Operate in a conspicuous place of our establishment;

3) And that we shall notify BFAD in case of any change(s) in the circumstances of our application for a License to Operate, were specifically including but not limited to change(s) of location, change of pharmacist-in-charge; an change in drug products.

We execute this Joint Affidavit of Undertaking of confirm the truth of our declaration and our awareness of the foregoing duties and responsibilities among others. WITNESS HEREOF, we hereunto affix our signatures this _______ day of _______________, 2006. ___________________________________ _______________________________________ Owner’s Name & Signature Pharmacist Name & Signature Res. Cert. No.________________________ Res. Cert. No.__________________________ Issued on. ___________________________ Issued on _____________________________ at __________________________________ at ___________________________________ Subscribed and sworn to me before this _________ day of ___________ at_______________ _____________________________________. ______________________________________ Notary Public Doc. No. _____________ Page No. ____________ Book No. ____________ Series of _____________

Affix Php15.00 documentary stamp

REPUBLIC OF THE PHILIPPINES

DEPARTMENT OF HEALTH BUREAU OF FOOD AND DRUGS

Alabang, Muntinlupa Metro Manila

P H A R M A C I S T’S A F F I D A V I T

TO WHOM IT MAY CONCERN :

THIS IS TO CERTIFY THAT ________________________________________________________________

(BOARD REGISTERED NAME) a duly registered pharmacist with Registration Certificate No. ___________issued on ____________, 2006_ with Privilege Tax Receipt No. ________________(PTR) dated _______________, 2006 is the pharmacist –in- charge of ______________________________________located at _______________________________ ________________________________________________ with office hours from _____ A.M. ______P.M. (Attached photocopy of Certificate of registration and 2x2 latest picture) This certification is further authenticated by the above mentioned pharmacist with signature appears below. ____________________________________ ________________________________________

Date Printed Name of Pharmacist ____________________________________ _________________________________________

Printed Name of Owner Signature _____________________________________ _________________________________________

Signature Address _____________________________________ Res. Cert. No. ________________________ Address Issued at ___________________________

on ___________________________ Res. Cert. No. _________________________ PTR No. ____________________________ Issued at: _____________________________ Issued at ____________________________ On _________ ___________________ on ___________________________ Tel. No. ______________________________ Tel. No. ____________________________ SUBSCRIBED AND SWORN TO BEFORE ME THIS_____ day of ___________, 2006 Exhibited this/their Residence Certificate, the date of which are indicated below his/her respective name on page one hereof. Doc. No. ________________________ _ ___________________________________ Page No. ________________________ NOTARY PUBLIC Book No. _______________________ Series No. _______________________

Ρ 15.00 Documentary Stamps Note: This certification is valid until a written notification from either one of the above

Signatories of any change of pharmacist shall have been filed and duly acknowledge by this office. In case of any change of pharmacist : This replace ________________________________________ with, Registration Certificate No. ____________ issued on __________________, 200__ who Resigned on _____________________________, 2006.

_______________________________________ OWNER

CHECKLIST OF REQUIREMENTS FOR OPENING OF DRUG/MEDICAL DEVICE/COSMETIC ESTABLISHMENT

For Pre-application as Manufacturer/Repacker: _____ 1. Submit Letter of Intent for pre-site inspection (Fee: P500) _____ 2. Lay out review (scheduled every Monday only) GENERAL REQUIREMENTS: _____ 1. Information as to activity (ies) of establishment _____ 2. Notarized Accomplishment Petition Form/Joint Affidavit of Undertaking _____ 3. Photocopy of Business Name Registration

a. For single proprietorship, registration from the Department of Trade and Industry (DTI) b. For corporation/partnership, registration from the Securities & Exchange Commission (SEC) and Articles

of Incorporation. Note:

a. If the registered address with DTI/SEC is different from the address of the establishment to be licensed, submit a photocopy of the Business/Mayor’s Permit

b. If the establishment adopts another business name/style different from the corporation name submit registration of the business name/style with DTI.

_____ 4. ID Pictures of the Owner / Authorized Representative and Pharmacist (size: 5cm x 5cm.) _____ 5. Photocopy of Pharmacist’s Registration Board Certificate / PRC ID and PTR _____ 6. Photocopy of Certificate of BFAD Seminar on Licensing of Establishment by the Pharmacist. _____ 7. Photocopy of notarized valid Contract of Lease of the space/building occupied (if the space/bldg. is not owned) _____ 8. Photocopy of Financial Statement duly notarized or received by Bureau of Internal Revenue (BIR), if not available; submit notarized certification of initial capital invested. _____ 9. Location Plan/Sit (indicate size, location, immediate environment, type or building) _____ 10. List of products to be manufactured/distributed in generic and brand names (indicate the therapeutic classification, dosage form and strength) _____ 11. Duties and responsibilities of the pharmacist (for readers) _____ 12. Reference Books:

a. USP/NF (latest edition) b. R.A. 3720, R.A. 6675 R.A. 5921 c. Remington’s Pharmaceutical Sciences (latest edition) d. Goodman & Gilman Pharmaceutical basis of Therapeutics e. British Pharmacopoeia f. Philippine National Drug Formulary g. Philippine Pharmacopoeia

*For Drug – a & b (mandatory) and any reference from c – g *For Medical Devices – b and other BFAD regulations pertaining to Medical Devices *For Cosmetics – b, other official monographs, if applicable (e.g. USP, BP) and other BFAD regulations pertaining to Cosmetics

A. For manufacturer: ADDITIONAL REQUIREMENTS:

_____ 1. Site Information File (SIF) B. For Repacker; _____ 1. Site Information File (SIF) _____ 2. Notarized valid Contract/Agreement with the manufacturer with stipulation that both the

Manufacturer and Repacker are jointly responsible for the quality of the products _____ 3. Photocopy of the License to Operate (LTO) of contract manufacturer C. For Trader: _____ 1. Notarized valid Contract/Agreement with the manufacturer with stipulation that both the Manufacturer and Trader are jointly responsible for the quality of the products _____ 2. Floor plan of office and storage area. _____ 3. Photocopy of the License to Operate (LTO) of contract manufacturer/speaker. D. For Importer of Raw Materials / Finished Products in Bulk: _____ 1. Foreign Agency Agreement duly authenticated by the Territorial Philippine Consulate _____ 2. Certificate of Status of manufacturer (CGMP Certificate) issued by a Government Health Agency duly authenticated by the Territorial Philippine Consulate. FEE: See Schedule of Fees of LTO at the back page