Oct 3, 2012

UPDATED!


Whether a business is Single Proprietorship, Partnership, or Corporation, the following requirements must be accomplished. Having all these documents will prove that your business is legit.



1. Business Name (BN) Registration
    1.1.For Single Proprietorship, you will need to be registered at Department of Trade & Industry (DTI) local offices. You can also apply for BN online through DTI official website.  BN registration is under the REVISED IMPLEMENTING RULES AND REGULATIONS OF ACT 3883, AS AMENDED, OTHERWISE KNOWN AS THE BUSINESS NAME LAW. The validity of BN is 5 years from the date of original registration and must be renewed afterwards.

 Requirements:
  1. Accomplished BN Registration Form
  2. Tax Identification Number (TIN) (Optional)
  3. 5 business names to chose from
  4. Registration Fee will depend on your territory
·         Php 200 for Barangay
·         Php 500 for City/Municipality
·         Php 1000 for Regional
·         Php 2000 for National
Plus Php 15 for documentary stamp

       1.2. For Partnership, you will need to acquire Securities and Exchange Commission (SEC) Certificate from Securities and Exchange Commission (SEC) Office at SEC Building, Edsa, Greenhills, Mandaluyong City or visit the SEC official website for online registration.
Requirements:



       a.  Verification Slip Form (this pertains to the proposed name)
       b.  Articles of Partnership (notarized)
       c.  Written Undertaking to Change Corporate Name (notarized)
       d.  Accomplished Registration Data Sheet
       e.  Deed of Assignment executed by the stockholder (owner), if the contributed capital is a real property.
       f.   Registration Fee


2. Mayor’s Permit – This should be acquired in local municipality where your business is located. The validity of Mayor’s Permit is one year and submits for renewal afterwards.

Requirements:
         a. Barangay Clearance- obtained where the business is located
         b. Accomplished Business Permit Application Form
         c. Business Name Certificate (Either from DTI or SEC)
         d. Business location sketch
         e. SSS Certification/Clearance
         f. Least contract if place is rented/tax declaration
        g. Community Tax Certificate (Cedula)
        h. 2 pieces 2×2 colored ID Picture
        i. Registration fee depending on the type of the business

3. Tax Identification Number (TIN) to be acquired at Revenue District Office (RDO) having jurisdiction over the registered business address.

Requirements:
                a. Birth certificate or any valid identification showing name, address and birth date
                b. Mayor’s permit or application for Mayor’s Permit (when applicable)
                c. Certificate of Registration of Business Name (to be submitted prior to the issuance of the BIR Certificate of Registration (COR)
                d. Accomplished BIR Form 1901
                e. Paid Annual Registration Fee of Php 500 at the Authorized Agent Bank of RDO
                f. Other fees:
                Php 15.00 for Certification Fee
                                Php 15.00 for Documentary Stamp Tax attached to Certificate Registration (Form 2303)

For more information please contact Bureau of Internal Revenue (BIR) National Office at Agham Road, Diliman, Quezon City or call them at (632) 981.7000 / 981.8888. You can also email them at contact-us@cctr.bir.gov.ph or visit  BIR official website.

4. Social Security System (SSS) Certificate to be acquired at your local SSS Office.
Requirements:
  1. Accomplished BR-1 Form
  2. Business Certificate from DTI or SEC
  3. No charge on registration
For more details, you can visit the SSS Official Website or email them at member_relations@sss.gov.ph. You can also contact them at (632)920.6401 / 920.6446

5. License to Operate (LTO) issued by FDA Philippines.
Requirements to be submitted at FDA Office:
  • Notarized Petition Form and Joint Affidavit of Undertaking duly accomplished
  • Clearance of the Pharmacist
  • Pharmacist Board Certificate, Valid PRC-ID picture, Duties and Responsibilities of the Pharmacist, Valid PTR, 2x2 colored ID picture (2 pcs) and Certificate of Attendance on a FDA accredited seminar on Licensing of Drug Establishment and Outlets and Seminar on EDPMS (NCPAM)(Photocopies to be verified with the original copies)
  • Certificate of Business Name/Proof of Registration 
- from Department of Trade and Industry (DTI) if Single Proprietorship;along with the Mayor's Business Permit or Barangay Permit with the registered name and address of the retailer.
- from Cooperative Development Authority (CDA) if Cooperative 
- from Security and Exchange Commission (SEC) if Partnership or Corporation; if Corporate name is different from the Business Name, Business Name should be reflected in SEC Registration. If Corporate Address is different from the Business Address, Mayor's Business Permit or Baranggay Business Permit with registered business name and address should be acquired.
- submit a copy of Franchise Agreement and proof of registration of franchisor.
  • Floor area not less than 15 square meters
  • Picture of drugstore with signboard with the exact business name
  • Contract of Lease for the space if it is rented (notarized)
  • Valid Homeowner's Association (HOA) Clearance when applicable
  • Location including landmarks and Floor plan with dimension including all the areas
  • Generic white and red labels
  • Tentative list of products to be sold using generic and brand names, if any
  • Rubber stamp of outlets with the registered name and address
  • Registration Fee of Php 1000.00 plus 1% Legal Research Fee valid for 1 year and subjects to renewal afterwards.
Upon inspection the following materials should be available at the pharmacy:
  1. Reference Materials
·         RA 5921 known as Pharmacy Law
·         RA 3720 known as Food, Drugs and Cosmetic Act
·         RA 6675 known as Generics Act of 1988
·         RA 8203 known as Special Law on Counterfeit Drugs
.         RA 9502 known as The Universally Accessible Cheaper and Quality Medicines Act of 2008, E.O. \821 Prescribing the Maximum Drug Retail Prices for Selected Drugs and Medicines that Address Diseases that Account for the Leading Causes of Morbidity and Mortality (MDRP), Advisory Council for Price Regulation \2009-001 Government-Mediated Access Price (GMAP)
.         RA 9711 known as The Food and Drug Administration Act of   2009
.         AO#56 s. 1989 Licensing of Drug Establishments and Outlets
·         Philippine National Drug Formulary (PNDF) (latest edition)

Note: RA print outs are usually provided at FDA Accredited Seminar on Licensing of Drug Establishment and Outlets.

  1. Any of the following reference books (latest edition):
·         United States Pharmacopeia/National Formulary (USP-NF)
·         Remington’s Pharmaceutical Science
·         Goodman and Gilman Pharmacological Basis of Therapeutics

  1. Record Books (Prescription Books, Senior Citizen's, Persons with Disability) duly registered with FDA Philippines
  2. Menu Card (Generics, MDRP, GMAP)
  3. Dispensing Apparatus (spatula, tablet counter, and graduated cylinder)
  4. Cold Storage for vaccines and biological products
Note: In order to verify documents during inspection, original documents must be presented. LTO application for drug retailer is accepted on Tuesdays and Wedsnesdays from 8:00AM to 3:00 PM only.

FDA Checklist of Requirements for Drug Retailer
FDA Checklist of Requirements for Drugstore/Hospital Pharmacy/Retail Outlet for Non-Prescription Drugs
Disclaimer: 
The information and reference materials contained here are intended solely for the general information of the reader and NOT intended to replace the official source. The owner of this site disclaims any responsibility for the decisions you make based on this information. 

First published: February 24, 2011
Edited: October 3, 2012
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