Starting a Pharmacy When starting a Pharmacy business, the first step to consider is to apply for a Business Registration.

PinoyEntrepreneur have provided a detailed information to register your Pharmacy business in the Philippines. FOR SINGLE PROPRIETORSHIP 1. Business Name Registration Visit Department of Trade & Industry (DTI) Provincial Office where the business is located or log on to www.bnrs.dti.gov.ph Validity : 5 years Requirements:

   

Accomplished Business Name Registration Form [Single Proprietorship/Partnership (Optional) Tax Identification Number (TIN) (Optional) List of five business names ranked according to preference Registration fee of Php300.00

2. Mayors Permit Agency: Local municipality where the business is located Validity: 1 year Requirements:

    

Accomplished Business Permit Application Form DTI Business Name Certificate Sketch of the business location 2 pcs. 22 colored ID Picture Registration fee, the amount of which depends on the type of the business

3. Tax Identification Number (TIN) Agency: Bureau of Internal Revenue (BIR) National Office, Agham Road, Diliman, Quezon City Trunkline: (632) 981.7000 / 981.8888 Email: contact-us@cctr.bir.gov.ph Website: www.bir.gov.ph Requirements: (to be submitted to BIR Revenue District Office where the business is located)

   

Accomplished Form 1901 DTI Certificate of Registration of Business Name Mayors Permit Registration Fee of Php500.00

4. Social Security System (SSS) Loans and Investment Office SSS Building, East Avenue, Diliman, Quezon City Tel. Nos.: (632)920.6401 / 920.6446

Email: member_relations@sss.gov.ph Website: www.sss.gov.ph Requirements:

  

Accomplished R1 Form DTI Business Permit Mayors Permit

5. Department of Labor and Employment (DOLE) Registration (with 5 or more employees) Agency: Department of Labor and Employment (DOLE) Labor Standard and Enforcement Division Address: 2nd Flr. Dy International Building, San Marcelino cor. Gen. Malvar St., Malate, Manila Tel. No.: (632) 339.2013 Hotline No.: 527.8000 Email: osec@dole.gov.ph Website: www.dole.gov.ph Requirements:

  

Accomplished Rule 1020 Form Lay-out of business location Vicinity map

OTHER AGENCY 1. Bureau of Food and Drugs (BFAD) Certificate Agency: Bureau of Food and Drugs Civic Drive, Filinvest Corporate City Alabang, Muntinlupa City Tel. Nos. (632) 807.0721 / (632) 842.5606 Email: bfad@bfad.gov.ph Website: www.bfad.gov.ph Requirements:

           

Notarized Petition Form/Joint Affidavit of Undertaking duly accomplished Tentative list of products using generic and brand names, if any Floor area not less than 15 square meters; Generic white labels Dry seal or rubber stamp of outlets Pharmacist Registration Certificate PRC-ID, valid PTR, ID picture and certificate of attendance of owner/pharmacist to a BFAD sponsored/accredited seminar on Licensing of Drug Establishments and Outlets If single proprietorship, Certificate of Business Name Registration from the DTI If corporation, copy of registration with SEC and Articles of Incorporation or Partnership Contract of Lease for the space to be occupied if the owner does not own it Picture of drugstore with signboard Additional:

             

Location Plan Floor Plan with dimension.

The following reference books must be present: Philippine National Drug Formulary R.A. 3720 otherwise known as Food, Drugs & Devices & Cosmetics Act R.A. 6675 otherwise known as Generics Act of 1988 and relevant implementing rules and regulations R.A. 5921 otherwise known as Pharmacy Law as amended and relevant implementing rules and regulations R.A. 8203 otherwise known as Special Law on Counterfeit Drugs

Any of the following reference books: United States Pharmacopoeia/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)

Registration fee of Php1,000.00

Application for Permit to Construct a Clinical Laboratory

Where to File:
BUREAU OF HEALTH FACILITIES AND SERVICES Bldg. 15, San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila

How to File:
Submit application to the Bureau of Health Facilities and Services. A copy of Permit to construct and Approved Floor Layouts shall be issued within 15 working days upon receipt of application provided that all documents are complete and compliant. NOTE: LICENSING REQUIREMENTS OF A CLINICAL LABORATORY SERVICE CAPABILITY PRIMARY CATEGORY Routine Fecalysis

Routine Hematology (Complete Blood Count or CBC) includes Hemoglobin Mass Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocytes Number Concentration (White Blood Cell or WBC Count), Leucocytes Type Number Fraction (Differential Count) and Qualitative Platelet Determination Routine Urinalysis Blood Typing hospital based Quantitative platelet determination hospital based SECONDARY CATEGORY ALL those in Primary Category PLUS the following: Routine Clinical Chemistry includes Blood Glucose Substance Concentration, Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration and Blood Total Cholesterol Concentration Cross matching hospital based TERTIARY CATEGORY ALL those in Secondary Category PLUS the following: Immunology/Serology Microbiology Special Chemistry Special Hematology PERSONNEL 1. The Clinical Laboratory shall be managed by a licensed physician certified by the Philippine Board of Pathology. 1.1. In areas where pathologists are not available, a physician with a three (3) months training on clinical laboratory medicine, quality control and laboratory management, may manage a primary/secondary category clinical laboratories. The BHFS shall certify such training. 2. The clinical laboratory shall employ qualified and adequately trained personnel. Work assignment shall be consistent with the qualification of the concerned personnel.

2.1. A clinical laboratory shall have sufficient number of registered medical technologists proportional to the workload and shall available at all times during hours of laboratory operation. For hospital-based clinical laboratory, there shall be at least one registered medical technologist per shift to cover the laboratory operation. 3. There shall be staff development and appropriate continuing education program available at all levels of organization to upgrade the knowledge, attitudes and skills of staff. EQUIPMENT/INSTRUMENT 1. There shall be sufficient number and types of appropriate equipment/instrument in order to undertake all the laboratory examinations and procedures. The equipment/instrument shall comply with safety requirements. PRIMARY CATEGORY Clinical centrifuge Differential blood cell counter or its equivalent Hemacytometer Hemoglobinometer or its equivalent Microhematocrit centrifuge Microscope w/ oil immersion objective SECONDARY CATEGORY ALL those in Primary Category PLUS the following: Photometer or its equivalent Refrigerator Timer or its equivalent Water bath or its equivalent TERTIARY CATEGORY ALL those in Secondary Category PLUS the following: Autoclave Balance, trip/analytical Biosafety cabinet or its equivalent Drying oven

Incubator Rotator Serofuge or its equivalent 2. For other laboratory examinations being performed, the appropriate equipment for performing such procedures shall be made available. PHYSICAL PLANT 1. Adequate area shall be provided for the people, activity, furniture, equipment and utility. PRIMARY CATEGORY Minimum of 10 square meters in floor area Access to Toilet Clinical Work Area with Sink Pathologist Area SECONDARY CATEGORY Minimum of 20 square meters in floor area Toilet Clinical Work Area with Sink Pathologist Area TERTIARY CATEGORY Minimum of 60 square meters in floor area Toilet Clinical Work Area with Sink Pathologist Area Microbiology Room 2. A clinical laboratory shall be of such construction so that no hazards to the life and safety of patients, personnel and public exist. It shall be capable of withstanding weight and elements to which they may be subjected.

3. It shall be provided with sufficient illumination and adequate ventilation to enable personnel in the performance of work and to ensure comfort of patients, personnel and public. 4. Floors, walls, ceilings, fixtures and furniture shall be of sturdy materials that shall allow durability, ease of cleaning, fire and acid resistance. 5. There shall be measures for detecting fire such as fire alarms in walls, peepholes in doors or smoke detectors in ceilings. There shall be devices for quenching fire such as fire extinguishers or fire hoses that are easily visible and accessible in strategic areas. 6. Proper maintenance shall be provided to prevent untimely breakdown of building and equipment. 7. Liquid waste shall be discharged into an approved public sewerage system, and solid waste shall be collected, treated and disposed of in accordance with applicable codes, laws or ordinances. 8. References shall be made to the following: P. D. 1096 National Building Code of the Philippines and Its Implementing Rules and Regulations P. D. 1185 Fire Code of the Philippines and Its Implementing Rules and Regulations P. D. 856 Code on Sanitation of the Philippines and Its Implementing Rules and Regulations R. A. 1378 National Plumbing Code of the Philippines and Its Implementing Rules and Regulations R. A. 184 Philippine Electrical Code Manual on Technical Guidelines for Hospitals and Health Facilities Planning and Design. Department of Health, Manila. 1994 Health Facilities Maintenance Manual. Department of Health, Manila. 1995 Manual on Hospital Waste Management. Department of Health, Manila. 1997

Other Documentary Requirements:

Letter of Endorsement from the Director of the Center for Health Development Four (4) Sets of Floor Layout, showing location of equipment and areas required, appropriately dimensioned, properly identified and completely labeled DTI/SEC Registration (for private clinical laboratory)