Microsoft word - checklist of reqmt. for drug distributor & medical devices

CHECKLIST OF REQUIREMENTS FOR DRUG DISTRIBUTOR / MANUFACTURER; MEDICAL DEVICE; COSMETIC ESTABLISHMENTS General Requirements: (ALL FORMS TO BE ACCOMPLISHED IN TRIPLICATE) _________ Information as to activity of the establishment _________ Notarized Accomplished Petition Form / Joint Affidavit of Undertaking _________ Photocopy of Business Name Registration with DTI (if single proprietor); with SEC (if corporation/partnership) and Articles of Incorporation _________ ID Picture of the Owner / Gen. Manager and Pharmacist (size 2 x 2) _________ Photocopy of Pharmacist’s Registration Board Certificate, PRC-ID, PTR and Certificate of Attendance to any Sponsored/Accredited Seminar on Licensing of Establishment _________ Notarized valid Contract of Lease of the space/building occupied, if the applicant _________ Location Plan / Site (size, location, immediate environment, type of building) _________ List of Products to be manufactured/distributed in Generic and Brand Names (therapeutic classification dosage & strength) _________ Number of personnel (technical and non-technical), the academic qualification and _________ Duties and responsibilities of the Pharmacist and other Technical Personnel _________ Notarized Financial Statement of Cosmetic and Medical Device Establishment _________ If importing raw materials and/or finished products add C 1 requirements _________ Distribution Record Book duly registered with BFAD _________ Reference Books: 1. USP/NF (latest edition) 2. R.A. 3720; R.A. 5921 3. Remington’s Pharmaceutical Sciences (latest ed.) 4. Goodman & Gilman Pharmaceutical Basis of Additional Requirements: A. MANUFACTURER _____ Information Sheet _____ Floor Plan with complete dimensions and proper identification of areas with description _____ Organizational structure _____ List of Manufacturing / Quality Control equipment and facilities (per AO 56) B. TRADER _____ Notarized valid Contract of Agreement with the manufacturer with stipulation that both Manufacturer / Repacker and Trader are jointly responsible for product quality. C. DISTRIBUTOR 1. IMPORTER: _____ Foreign Agency Agreement _____ Certificate of Status of Manufacturer (cGMP Certificate) issued by a Govt. Health Agency 2. EXPORTER: _____ A valid Contract of Agreement with BFAD Licensed Manufacturer/Supplier 3. WHOLESALER: _____ A valid Contract of Agreement with BFAD Licensed Manufacturer/Trader and/or Distributor _____ Certificate of Product Registration (CPRs) _____ Copy of License to Operate of Suppliers Changes 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/Transfer of Rights in case of change of ownership _____ Notarized Affidavit of Pharmacist in case of change of pharmacist IN THE MATTER OF PETITION OF: ________________________________________________ TO OPEN A DRUG / COSMETIC ESTABLISHMENT, MORE PARTICULARLY AS A: ______ Manufacturer ( ) Importer ( ) Exporter ( ) Wholesaler COMES NOW the undersigned petitioner unto the Bureau of Food and Drugs, Department of Health, 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 ____________________________________________, a duly registered pharmacist with Certificate of Registration No. _______________________ issued on ____________________________ ; FOURTH – That __________________________________ is the owner of said establishment with the postal address at ___________________________________________________________________ ; FIFTH – That the amount of capital invested for said establishment P ______________________; SIXTH - That the 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 or if it rules later that it is misleading. WHEREFORE, the petitioner respectfully prays 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. Davao City, Philippines, _______________________________ , 20 _____. The undersigned, as owner of the establishment, hereby declares under oath that he conforms to the declaration of the petitioner pharmacist. Owner: ___________________________________ Signature over Printed Name of Pharmacist Address: ___________________________________ Address: _______________________________ Residence Certificate No._______________________ Residence Certificate No. _________________ Issued on: _______________ at _________________ Issued on: _____________ at ______________ Telephone / Cellphone No.______________________ Telephone / Cellphone No.: ________________ 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. 1. For single proprietorship, attach CERTIFICATE OF BUSINESS NAME REGISTRATION from the Department of Trade and Industry (DTI). For corporation, partnership, or other juridical person, attach CERTIFICATE OF REGISTRATION with the Securities and Exchange Commission (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 products, prior to their introduction into the domestic commerce, must 3. Application must be accompanied by BFAD-LSS Form No. 6 re: Clearance of Name, for purpose of misbranding provisions of R.A. 3720. 4. For other requirements, consult BFAD License Inspector. (Drug, Pharmaceutical / Cosmetic and/or Manufacturing Laboratory) (To be filled-up by Proprietor referring to physical plant equipment & personnel) Name of Proprietor: _________________________________________________ Name of Establishment: ______________________________________________ Address of Pharmaceutical, Drug Manufacturing Lab.: _____________________ _________________________________________________________________ List of Product to be Manufactured: ____________________________________ Floor plan of Laboratory: (Diagram including the adjacent grounds indicating location of windows and doors, their dimensions and their directional exposures. Floor and lower half of the wall and sink location. Mention essential laboratory basic facilities necessary for the manufacture (e.g. vacuum, compressed air, electrical connection, steam & gas) a. General equipment and apparatuses: 1. _____________________________ 6._____________________________ 2. _____________________________ 7. _____________________________ 3. _____________________________ 8. _____________________________ 4. _____________________________ 9. _____________________________ 5. _____________________________ 10. _____________________________ b. Specific production equipment especially concerned in the products to be 1. _____________________________ 6._____________________________ 2. _____________________________ 7. _____________________________ 3. _____________________________ 8. _____________________________ 4. _____________________________ 9. _____________________________ 5. _____________________________ 10. _____________________________ VII. Source of Raw Materials to be used: a. Local : _________________________________________________________ b. Imported : ______________________________________________________ c. Import finished product for rebottling only : ____________________________ e.) Helpers & Janitors _____________ Capital Invested: P ____________________________ Estimated output of each product per day or month: _______________________ I, declare that the foregoing statement is true, correct and complete to the best of my Knowledge and belief. ________________________________ ________________ ____________ Name & Signature of Authorized Person I, ____________________________________________________, Pharmacist-In-Charge with PRC Registration Number : __________________ Issued on : _______________________________ PTR No. : _______________________________ of legal age, single/married and a resident of ________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ located at ___________________________________________________________________ of legal age, and a resident of ___________________________________________________ after having been sworn in accordance with law, hereby declares: That we are fully aware of the provisions of Pharmacy 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 with business hours being from __________ AM to __________ PM; That we agree to change the business name if there is already as validly registered name similar to business name; That we shall display the approved License to Operate in a conspicuous place of my establishment; 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 pharmacist-in-charge and change in drug products; And that the Pharmacist-in-charge, will not be in any way connected with any other drug or similar establishment/outlet; WITNESS HEREOF, I hereunto affix our signatures this ________ day of ___________________, 200___. _______________________________ SUBSCRIBED AND SWORN to me this _______ day of __________________,

Source: http://www.chd11.doh.gov.ph/rledweb/Checklist%20of%20Reqmt.%20for%20Drug%20Distributor%20&%20Medical%20Devices.pdf