CHECKLIST OF REQUIREMENTS FOR DRUGSTORE / CHINESE DRUGSTORE / HOSPITAL PHARMACY / RETAIL OUTLET FOR NON-PRESCRIPTION DRUGS

General Requirements: (ALL FORMS MUST BE ACCOMPLISHED IN TRIPLICATE)

Notarized Acco mplished Petition Form / Joint Affidavit of Undertaking Tentative list of products using generic names and brand names, if any Floor area, not less than 15 square meters Reference Books Philippine National Drug Formulary R.A. 3720 otherwise known as Food, Drugs and Devi ces and Cosmetic Act R.A. 6675, Generics Act of 1988 and relevant implementing rules and regulations R.A. 5921, Pharmacy Law as amended and relevant implementing rules and regulations R.A. 8203, Special Law on Coun terfeit Drugs.

Any of the following Reference Books: United States Pharmacopo eia / National Formulary (USP-NF) latest edition Remingtons Pharmaceutical Sciences (latest edition) Goodman and Gillman Pharmacological Basis of Therapeutics (latest edition)

Record Books duly registered with BFAD (Prescription Book) Generic, White, and Red Labels Dry Seal or rubber stamp of outlets Photocopy of Pharmacists Registration Board Certificate, Valid PRC-ID, Valid PTR, 2x2 ID Picture and Certificate of Attendance of owner/ pharmacist to any BFAD Sponsored / Accredited Seminar on Licensing of Establishments and outlets If Single proprietorship, Certificate of Busin ess Name Registration with the Bureau of Trade Regulation and Consumer Protection (BTRCP) formerly known as Bureau of Domestic Trade. If Corporation/Partnership, copy of Registration with SEC and Articles of Incorporation or Partnership. Notarized valid Contract of Lease of the space/building occupied, if the applicant does not own it. Picture of Drugstore with signboard Opening Fee of P1,000.00 (Based on A.O. 50 series of 2001 ) Additional Requirements: Location Plan / Site (size, location, immediate environment, type of building) Floor Plan with dimensions (Lay-out of the premise s) Chang es in Circumstances: Official letter re: Change of Address / Owner / Business Name and/or etc. Surrender original / old License to Operate and COC / CTR Deed of Sale / Trans fer of Rights in case of change of ownership Notarized Affidavit of Pharmacist in case of change of pharmacist

Republic of the Philippines Department of Health

FOOD AND DRUG ADMINISTRATION

IN THE MATTER OF PETITION OF: TO OPEN A DRUG / COSMETIC ESTABLISHMENT, MORE PARTICULARLY AS A: Retail Drugstore Chinese Drugstore Hospital Pharmacy Retail Outlet for Non-Prescription Drugs (RONPD) Drug Distributor (Importer-Exporter, Wholesaler)

P ETITION COMES NOW the undersigned petitioner unto the Bureau of Food and Drug s, Depart ment of Hea lth, Alabang, City of Muntinlupa, Metro 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 establishment, more particularly, a to be located at and shall be known as with Tel.No. ; THIRD - That said establishment shall be open for business from A.M. to P.M. and shall be und er the personal and immediate supervision of , a duly registered pharmacist with Certificate of Registration No. issued on ; FOURTH That is the owner of said establishment with

the postal addre ss at ; FIFTH That the amount of capital invested for said establishment P ; SIXTH That the petitioner her eby agree s to change the business 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 mislea ding. WHERE FORE, the petitioner respectfully pra ys that she/he be granted License to Operate a drug / cosmetic / medical device establishment after inspection thereof and after compliance with the Bureau of Food and Drugs requirements, rules and regulations. Metro Manila, Philippines, , 20 . The und ersigned, as owner of the establishment, hereby declares under oath that he conforms to the declaration of the petitioner pharmacist. Respectfully submitted:

Owner: Signature over Printed Name Address : Residence Certificate No. Iss ued on: Telephon e / Cellphon e No. Signature over Printed Name of Pharmacist Address : Residence Certificate No. at Telephon e / Cellphon e No.: at

Iss ued

on:

SUBSCRIBED AND SWORN to before me this day of , 20 . Affiant exhibited to me his/her Residence Certificate(s), the date of which are indicated below his/her Respective name(s) on page hereof.
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SUBSCRIBED AND SWORN to before me this day of , 20 . Affiant exhibited to me his/her Residence Certificate(s), the date of which are indicated below his/her Respective name(s) on page hereof.
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INSTRUCTIONS 1. For single proprietorship, atta ch CERTIFICATE OF BUSINESS NAME REGISTRATION from the Depart ment of Trade and Industry (DTI). For corporation, partnership, or other juridical per son, attach CERTIFICATE OF REGISTRATION with the Securities and Exchange Commiss ion (SEC), together with a copy of Articles 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 produ cts, prior to their introduction into the domestic commerce, must first be registered with BFAD. 3. Application must be accompanied by BFAD-LSS Form No. 6 re: Clea rance of Name, for purpose of misbranding provisions of R.A. 3720. 4. For other requirements, consult BFAD Lice nse Inspec tor.

JOINT AFFIDAVIT OF UNDERTAKING

I,
(Family Name, First Name, Middle Name)

, Pharmacist-In-Charge with PRC Registration Number : Iss ued on : PTR No. :

of legal age, single/married and a resident of

(Pe rmanent Home Addre ss )

and OWNER of
(Name of Company)

located at
(Address of Company)

of legal age, and a resident of after having been sworn in accorda nce with law, hereby declares: 1. That we are fully aware of the provisions of Pharma cy Law, the Foods, Drugs, Devices and Cosmetics Acts, the Generics Act of 1988 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 business hours being from AM to PM; 2. 3. 4. with

That we agree to change the bu siness name if there is already as validly registered name similar to business name; That we shall displ ay the appro ved Lice nse to Op erate in a conspicuou s place of my establishment; That we shall noti fy BFAD in case of any chang e(s) in the circumstance s of our application for a license to opera te, including but not limited to change( s) of location, change of pharmacist-in-charge and change in drug products; And that the Pharmaci st-in-charge, or similar establishment/outlet; WITNESS HEREOF, , 200 w ill not be in any way conne cted with any other drug signatures this day of

5.

I hereunto affix our .

Owner Re s. Cert. No. Iss ued On At Re s. Cert. No. Iss ued On At

Pharmacist

200

SUBSCRIBED AND SWORN to me this , at .

day of

NOTARY PUBLIC Until December 31, 20 Doc. No. Page No. Book No.
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