PHARMACY BUSINESS REQUIREMENTS(PHILIPPINES)

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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:

a. Accomplished BN Registration Form

b. Tax Identification Number (TIN) (Optional)

c. 5 business names to chose from

d. 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

Note: Registration Fee as of January 2011

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:

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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:

a. Accomplished BR-1 Form

b. Business Certificate from DTI or SEC

c. 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

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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:

a. 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)

New er Post Older Post

Note: RA print outs are usually provided at FDA Accredited Seminar on

Licensing of Drug Establishment and Outlets.

b. 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

c. Record Books (Prescription Books, Senior Citizen's, Persons with

Disability) duly registered with FDA Philippines

d. Menu Card (Generics, MDRP, GMAP)

e. Dispensing Apparatus (spatula, tablet counter, and graduated

cylinder)

f. 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

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 responsibil ity for the decisions you make based on this information.

First published: February 24, 2011

Edited: October 3, 2012

Posted in: Pharmacy Business

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