CHECKLIST OF REQUIREMENTS FOR

MEDICAL DEVICE & COSMETIC DISTRIBUTOR

_ Accomplished Notarized Petition Form/Joint Affidavit of Undertaking
_ List of Medical Device/Cosmetic Products to be importer/distributed
_ Copies of Pharmacist Board Registration Certificate, PRC-ID, valid PTR, ID picture,
Duties and
Responsibilities, Certificate of Attendance of Owner/Pharmacist to a BFAD seminar
on Licensing of
Drug Establishments and Outlets
_ Location Plan and Floor Plan (Office and Storage Room) with dimensions.
Photocopies of the following:
_ If corporation, Registration Certificate with SEC and Articles of Incorporation or
Partnership
_ If single proprietorship, Certificate of Business Name Registration with Bureau of
Trade Regulation
and Consumer Protection (BTRCP)
_ Contract of Lease for the space of the office and storage to be occupied or any
proof ownership if it
is owned by the applicant.
_ If Importer:
o Foreign Agency Agreement from each supplier duly authenticated by the
Territorial
Philippine Consulate
o Certificate of Registration of manufacturer and its conformity with GMP From
Health
Authority/ISO Certification for medical device
_ If Wholesaler
o A Valid contract with BFAD licensed supplier/manufacturer
o Certification that the product it sells are registered with BFAD
o LTO of manufacturer/supplier
_ If Exporter:
o A Valid contract with BFAD licensed supplier/manufacturer
o Certification that the product it sells are registered with BFAD
o LTO of manufacturer/supplier
_ Fees to be paid (Based on A.O. 50 s. 2001
o Medical Device Distributor - P 4,000.00
o Cosmetic Distributor - P 3,000.00
1 Must be presented upon inspection:
o Copies of R.A. 5921 and R.A. 3720 as amended
o Batch Distribution Record Book
REPUBLIC OF THE PHILIPPINES
Department of Health
BUREAU OF FOOD AND DRUGS
Alabang, Muntinlupa City
IN THE MATTER OF PETITION OF
_____________________________________________________________
TO OPEN DRUG/COSMETIC & MEDICAL DEVICE ESTABLISHMENT
( ) Retail Drugstore
( ) Hospital Pharmacy
( ) Retail Outlet for Non-Prescription Drug
( ) Drug Distributor (Importer, Exporter, Wholesaler)
( ) Medical Device Distributor (Importer, Exporter, Wholesaler)
( ) Cosmetic Distributor (Importer, Exporter, Wholesaler)
XX________________________________________XX
PETITION
COMES NOW the undersigned petitioner unto the Bureau of Food and Drugs, Department of Health, Alabang,
City of Muntinlupa, 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 establishment particularly as
______________________________________________________ to be located at ___________________________
____________________________________________________________________________ and shall be known as
_______________________________;
THIRD - That the said establishment shall be open for business from ___________ AM to ___________ PM and shall be
under personal and immediate supervision of _______________________________, a duly registered pharmacist with
Certificate of Registration No. __________________ issued on _________________ 20 ____;
FOURTH - That __________________________________ is the owner of said establishment with postal address at
______________________________________________________________________________;
FIFTH - That the amount of Capital invested for said establishment is P_________________________;
SIXTH – That the pertinent petitioner hereby agrees 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 if it rules later that it is misleading;
WHEREFORE, the petitioner respectfully prays that he/she be granted a License to Operate a drug/cosmetic/medical
device establishment after inspection thereof and after compliance with requirements, rules and regulations of the Bureau
of Food and Drugs.
Metro Manila, Philippines, _____________________________20___________.
Respectfully submitted:
The undersigned, as owner of the
establishment, hereby declares under _____________________________________________
oath that the conforms to the declaration PRINTED NAME/SIGNATURE OF PHARMACIST
of the petitioner pharmacist. (Petitioner)
Owner: ________________________________________ Resident Cert. No. _________________________________
Address ________________________________________ Issued on ________________________________________
Resident Cert. No. _________________ Issued________ PTR No. ________________________________________
at ______________________________________________ Issued on ________________________________________
Tel. Number ____________________________________ Telephone Number ________________________________
SUBSCRIBED AND SWORN to before me this _______ day of _________ 20 _____ affiant exhibited to me his/her
Residence Certificate No. ______________________________ issued on _________________ at
________________________ on ________________ 20 _________.
_________________________________________
NOTARY PUBLIC
Doc No.
Book No.
Page No.
Series of
JOINT AFFIDAVIT OF UNDERTAKING
______________________________ PHARMACIST-IN-CHARGE
(PRC Registered Name) With PRC Registration No. ______________________
Issued on ___________________________________
PTR NO. ____________________________________
______________________________________
(Maiden or Maiden Name different from above)
of legal age, single/married, and a resident of __________________________________ and
_____________________________________________________________________________________ owner
of
_____________________________________________________________________________ (Drug
Establishment)
located at _______________________________________________________________ of legal age and
resident of
_________________________________________________ after having been sworn in accordance with
law, hereby
declare:
FIRST - That we are fully aware of the provisions of the Pharmacy Law, the Foods, Drugs,
Devices, and Cosmetics
Act, the Generics Act of 1988, 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 _______
AM to ________ PM
SECOND – that we agree to change the business name if there is already a validly
registered name similar to our
business name;
THIRD – that we shall display our approved License to Operate (LTO) in a conspicuous place
of our establishments;
FOURTH - that we 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 ownership, change of
pharmacist-in-charge, and
change in drug products;
FIFTH – and that I, the pharmacist-in-charge, am not and will not be in any way connected
with any drug or similar
establishment/outlet;
WE execute this Joint Affidavit of Undertaking to confirm the truth of our declaration and our
awareness of the
foregoing duties and responsibilities among others.
WITNESS WHEREOF, WE hereunto affix our signature this _________________day of
_____________ 20 _______..
__________________________________ ___________________________________
OWNER PHARMACIST
Res. Cert. No. ______________________ Res. Cert. No. ________________________
Issued on __________________________ Issued on ___________________________
at _______________________________ at _________________________________
SUBSCRIBED AND SWORN TO ME THIS _____________ day of _______________20 _______.
____________________________
NOTARY PUBLIC
Until December 31, 20