CITIZEN’S CHARTER1 month per AO 2012-0012 Transmit License to RLEC, DOH-ARMM Bureau of Health Facilities and Services (BHFS) Central Office San Lazaro Compound, Sta. Cruz, Manila

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Republic of the Philippines

Autonomous Region in Muslim Mindanao

Department of Health

CITIZEN’S CHARTER

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Table of Contents

List of Forms ......................................................................................................... 2

Vision .................................................................................................................... 3

Mission .................................................................................................................. 3

Performance Pledge ............................................................................................. 3

Contact Information ............................................................................................... 3

List of Frontline Services ....................................................................................... 4 Frontline Service: Application for Certificate of Need (CON) for New Hospitals 5 Frontline Service: Application for Permit to Construct (PTC) a General Hospital ........................................................................................................................ 12 Frontline Service: Application for Initial License to Operate (LTO) a Hospital . 14 Frontline Service: Application for Renewal of License ..................................... 19 Frontline Service: Application for License to Operate (LTO) a General Clinical Laboratory (Institution-based) .......................................................................... 24 Frontline Service: Application for Establishment, Operation of Radiation Emitting Apparatus (X-ray facilities - Free Standing) ....................................... 31 Frontline Service: Application for License to Operate (LTO) for Food and Drug Administration (FDA) ....................................................................................... 37

Application for Reissuance of Lost/Damaged License to Operate …………….. …………….52 Request for Change of Pharmacist ……………………………………………………………………………………..55

Request for Approval of Transfer of Location of the Drugstores ………………………………….58

Frontline Service: Application for Smoking Cessation Counseling .................. 61

Procedure of filing complaints / Feedback and/or Complaints Form .................. 62

Public Assistance Desk ....................................................................................... 62

Redress Mechanism ........................................................................................... 62

Automatic Extension of Licenses, Permits and Authorities ............................ 63-68

List of Forms

MamayanMuna, Hindi MamayanaForm No. 1 – Commendation (Papuri) MamayanMuna, Hindi Mamayana Form No. 2– Requesting for Assistance (PaghingingTulong) MamayanMuna, Hindi Mamayana Form No. 3 – Complaint (Reklamo) MamayanMuna, Hindi Mamayana Form No. 4 – Recommendation (Mungkahi) Customer Feedback Form

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Vision The DOH-ARMM as the Center of Excellence in Health facilities attainment of Optimum health for the people of ARMM by 2016.

Mission Ensure affordable, responsive, equitable, accessible, sustainable and quality health care services and systems in ARMM.

Performance Pledge We, the officials and employees of Department of Health of Autonomous Region in Muslim Mindanao pledge and commit to deliver quality public services as promised in this charter. Specifically, we will:

Serve with integrity.

Be prompt and timely, rendering service from Mondays to Fridays, 8:00 AM to 5:00PM

Display procedures, fees and charges.

Provide adequate and accurate information.

Be consistent in applying rules.

Provide feedback mechanism.

Be polite and courteous.

Demonstrate sensitivity and appropriate behavior and professionalism.

Wear proper uniform and identification.

Be available during office hours.

Response to complaints through feedback & redress mechanism

Provide comfortable waiting area.

Treat everyone equally and ethically.

Contact Information For inquiries, you may contact us at Public Assistance/Complaints Desk:

Postal Address Department of Health, ARMM Complex, Cotabato City

Direct Line (064) 421 - 6842

Fax Number (064) 421 - 6842

Mobile 0920 909 1094

Email-Address [email protected] , [email protected]

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List of Frontline Services

1. Application for Certificate of Need (CON) for New Hospitals 2. Application for Permit to Construct (PTC) a General Hospital 3. Application for Initial License to Operate (LTO) 4. Application for Renewal of License 5. Application for License to Operate (LTO) a General Clinical Laboratory

(Institution-based) 6. Application for Establishment, Operation of Radiation Emitting Apparatus

(X-ray facilities - Free Standing) 7. Application for License to Operate (LTO) for Food and Drug Administration

(FDA) 8. Application for Smoking Cessation Counselling

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Frontline Service: Application for Certificate of Need (CON) for New Hospitals Clients: Private Company, LGU Requirements:

1. Application form for Certificate of Need (CON) for new hospitals – Form can also be downloaded at www.doh.gov.ph 2. Certification from Provincial Planning and Development Office (PPDO) that the proposed hospital is part of the duly approved Provincial Hospital/Healthcare Delivery

Plan Other requirements for renewal of hospital are following:

3. Newborn Screening Certification/Data, 4. Philippine Integrated Decease Surveillance and Response updated Data (PIDSR), 5. Certificate of Cook 6. Certificate of Chief Nurse in Masteral at least 15 units, 7. Electronic Drug Price Monitoring System (EDPMS) monthly downloaded, 8. Water Analysis Certificate/data 9. Fire Certificate

Schedule of Availability of Service: Monday to Friday, 8:00 am to 5:00 pm No Noon Break

Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees:Php2,000.00: Total Processing Time:2 days and 4 hours and 40 minutes except travel time (Maguindanao - 5 hours; Lanao del Sur – 1 day; Basilan - 4 days; Tawi-Tawi – 4 days; Sulu – 4 days)

How to avail of the service:

Step No Client Step Agency Action Responsible Office/ Position

Location of Office Maximum Duration of Step

1 Submit duly accomplished application forms and other documents

Receive application forms and documents and check authenticity of requirements

Regulation Licensing and Enforcement Cluster (RLEC) / Licensing Officer

2nd Fl., Admin Building, DOH-ARMM, ORG Compound

10 minutes

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2 Claim order of payment Issue Order of Payment Regulation Licensing and Enforcement Cluster (RLEC) / Licensing Officer


5 minutes

3 Proceed to Cashier’s Office, present Order of Payment and pay application fee

Receive payment and issue official receipt

Cashier’s Office / Cashier 2nd Floor, Admin. Bldg.

DOH-ARMM, ORG Compound

10 minutes

4 Proceed to RLEC present official receipt

Get official receipt number and indicate in the application form



15 minutes

Evaluate application and recommend for onsite inspection



2 hours

Conduct onsite inspection and prepare report (if necessary)


Onsite Inspection Time - 2 hours Travel Time: Maguindanao - 5 hours Lanao del Sur – 1 day Basilan - 4 days Tawi-Tawi – 4 days Sulu – 4 days

Forward inspection report to the Regional Secretary for approval



10 minutes

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Approve/ sign CON If approved:Recommend CON and ready certificate for release If disapproved:Inform the applicantby mail on the particularreason for the disapproval of the application and provide the BHFS a copy of the completed application form and evaluation tool

RLEC/ Regional Secretary 2nd Fl., Admin Building, DOH-ARMM, ORG Compound

1 hour

5 Receive notice of approval or disapproval of CON

Notify client through their return address, phone number or email if application is approved or disapproved CON



30 minutes

6a. If disapproved: Submit letter of appeal to theSecretary of Health (DOH Central Office) within30 days after receipt of thenotice of decision

Receive letter of appeal and re-evaluate the application

Bureau of Health Facilities and Services (BHFS) Central Office

San Lazaro Compound, Sta. Cruz, Manila

2 days

6b. If approved: Proceed to RLEC to claim CON or advise RLEC to mail the CON to the return address

Issue certificate or mail the CONthrough courier service



20 minutes

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Frontline Service: Endorsement of Application for Permit to Construct (PTC) a General Hospital Clients: Private Company, LGU Requirements: Form No. 1-01: Application for Permit to Construct

1. Form can also be downloaded at www.doh.gov.ph 2. Three (3) sets of site development plansand architectural floor plans 3. New sets of floor plans (in case of existing hospitals have renovations) 4. Zoning Certificate 5. DTI/SEC Registration for Private 6. Enabling Act/Board Resolution (for government hospitals) 7. Certificate of Need (CON) for new hospitals

Note: Validity period is one (1) year Schedule of Availability of Service: Monday to Friday, 8:00 am to 5:00 pm No Noon Break

Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees: None Total Processing Time: 2 hours and 20 minutes except Turn Over Time BHFS-DOH Central Office (1 month) and Courier (2 days)


Step No Client Step AgencyAction Responsible Office/ Position



Receive application forms and documents and check completeness and authenticity of requirements



20 minutes

10

Prepare endorsement letter Forward to the Regional Secretary for signature



30 minutes

Sign letter of endorsement Forward to RLEC Licensing Officer

RLEC/ Regional Secretary


1 hour

RLEC packages information to Record Section for transmittal to DOH Central Office



10 minutes

Transmit to BHFS Central Office via courier



1 day

BHFS-DOH Central Office process the licensing



1 month per AO 2012-0012

Transmit License to RLEC, DOH-ARMM



1 day

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2 Receive notice of release of Permit to Construct (PTC) a General Hospital

Notify clients through phone call or text



10 minutes

3

Receive Permit to Construct (PTC) a General Hospital

Issued Permit to Construct (PTC) a General Hospital from BHFS-DOH Central Office will be released to the owner of the establishment.



10 minutes

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Frontline Service: Endorsement of Application for Initial License to Operate (LTO) a Hospital Clients: Private Hospitals, Government Hospitals Requirements:

a. Hospital

a. Form No. 2-01: Application Form for License to Operate a Hospital (notarized) - Form can also be downloaded at www.doh.gov.ph

b. Proof of qualification c. PRC ID of the Professional Personnel d. Certificate of Training of the Personnel e. Location map for the hospital f. Photographs of the exterior and interior of the hospital g. Annual Hospital Statistical Report

Note: Validity period is one (1) year Schedule of Availability of Service: Monday to Friday, 8:00 am to 5:00 pm No Noon Break

Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees: None Total Processing Time : 2 hours and 20 minutes except Turn Over Time BHFS-DOH Central Office (1 month) and Courier (2 days)





Receive application forms and documents and check completeness and authenticity of requirements



20 minutes

Prepare endorsement letter Forward to the Regional



30 minutes

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Secretary for signature

Sign letter of endorsement Forward to RLEC Licensing Officer


1 hour

RLEC packages information to Record Section for transmittal to DOH Central Office



10 minutes

Transmit to BHFS Central Office via courier



1 day

BHFS-DOH Central Office process the licensing



1 month per AO 2012-0012

Transmit License to RLEC, DOH-ARMM



1 day

2 Receive notice of release of Initial License to Operate (LTO)a Hospital




10 minutes

3 Receive Initial License to Operate (LTO)a Hospital

Issued Initial License to Operate (LTO)a Hospital from BHFS-DOH Central Office



10 minutes

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Frontline Service: Application for Renewal of License to Operate a Hospital Clients: Private Hospitals, Government Hospitals Requirements: )

1. Notarized application form for Renewal of License to Operate a Hospital 2. Proof of compliance based on the application form 3. Other requirements for renewal of hospital are following:

a. Newborn Screening Certification/Data, b. Philippine Integrated Decease Surveillance and Response (PIDSR), c. Certificate of Cook, d. Certificate of Chief Nurse in Masteral at least 15 units, e. Electronic Drug Price Monitoring System (EDPMS) monthly downdoaled, f. Water Analysis Certificate/data, g. Fire Certificate

Fees: For Private Hospitals only (P5,500.00 – for Level 1; P6,500.00 – for Level 2; P 7,500.00 – for Level 3) Total Processing Time: 4 hours and 10 minutes








10 minutes

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5 minutes



Cashier’s Office / Cashier 2nd Floor, Admin. Bldg. DOH-ARMM, ORG

Compound

10 minutes





15 minutes

Evaluate documents and check compliance Prepare renewed LTO



2 hours

Forward renewedLTO to the Regional Secretary for approval



10 minutes

Approve/ sign renewed LTO Forward to RLEC Licensing Officer for release


1 hour

5 Receive notice of release of renewed LTO




10 minutes

6 Receive renewed LTO Issue renewed LTO Regulation Licensing and Enforcement Cluster (RLEC) / Licensing Officer


10 minutes

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Frontline Service: Application for License to Operate (LTO) a General Clinical Laboratory (Institution-based) Clients: Private Laboratory Requirements: Notarized application form for License to Operate


Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees: P1,500.00 – for Primary laboratory; P2,000.00 – for Secondary laboratory; P2,500.00 for Tertiary laboratory Total Processing Time :6 hours and 40 minutes except travel time (Maguindanao - 5 hours; Lanao del Sur – 1 day; Basilan - 4 days; Tawi-Tawi – 4 days; Sulu – 4 days)








10 minutes

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5 minutes



Cashier’s Office / Cashier 2nd Floor, Admin. Bldg.

DOH-ARMM, ORG Compound

10 minutes





15 minutes

Evaluate documents and check compliance



2 hours

Conduct onsite inspection and prepare report


Onsite Inspection Time - 2 hours Travel Time: Maguindanao - 5 hours Lanao del Sur – 1 day Basilan - 4 days Tawi-Tawi – 4 days Sulu – 4 days

Forward inspection report to the Regional Secretary for approval



10 minutes

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Approve/ sign LTO for General Laboratory If approved: Recommend LTO for General Laboratory and ready certificate for release If disapproved: Inform the applicant to comply with findings


1 hour

5 Receive notice of approval or disapproval of LTO for General laboratory

Notify client through their return address, phone number or email if application is approved or disapproved CON



30 minutes

6 Proceed to RLEC to claim LTO for General laboratory

Issue LTO for General laboratory



20 minutes

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Application For License To Operate A General Clinical Laboratory

Name of Laboratory : ______________________________________________________ Address of Laboratory : ______________________________________________________ No. & Street Barangay ________________________________________ City/ Municipality Province Region Telephone/ Fax No. : ______________________________________________________ Head of the Laboratory : ______________________________________________________ Name of Owner : ______________________________________________________ Contact Number : ______________________________________________________ Classification According to Ownership : [ ] Government [ ] Private Function : [ ] Clinical Pathology [ ] Anatomic Pathology Institutional Character : [ ] Institution Based [ ] Freestanding Service Capability : [ ] Primary [ ] Secondary [ ] Tertiary [ ] Limited Status of Application : [ ] Initial [ ] Renewal License No. __________________ Date Issued __________________ Expiry Date __________________

Checklist of Application Documents 1. Please tick () the appropriate boxes under column B or C. Shaded Items are not required – Forms

can be downloaded at www.doh.gov.ph 2. Floor plan 3. List of personnel 4. Photocopies of the following:

a. PRC ID/PRC board certificate b. Specialty board certificate for medical staff c. Certificate of training/record of work experience

5. Proof of employment of the medical, paramedical and administrative staff 6. List of equipment/instrument 7. Location map of the laboratory building 8. SEC/DTI for private laboratories or Board Resolution for government laboratories

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Name Civil Status Age

Address

Signature

Acknowledgement REPUBLIC OF THE PHILIPPINES ) CITY/ MUNICIPALITY OF ______________) S.S.

I, ______________________________, ____________, of legal age, __________, a resident of ___________________________________________, after having been sworn in accordance with law hereby depose and say that I am executing this affidavit to attest to the completeness and truth of the foregoing information and the attached documents required for the Licensure and Regulation of Clinical Laboratories in the Philippines pursuant to Administrative Order No. 2007-0027 “Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines”.

_________________________

Before me, this _________day of ______________ 2007 in the City/ Municipality of ________________, Philippines, personally appeared

Owner Community Tax Number Issued at/ on _______________________________ _________________________ _________________________

known to me to be the same person/s who executed the foregoing instrument and they

acknowledge to me that the same is their free act and deed.

IN WITNESS WHEREOF, I have hereunto set my hands this _________day of _______________ 2007. Doc. No. ____________________ NOTARY PUBLIC Page No. ____________________ My Commission Expires Book No. ____________________ Dec. 31, _______ Series of ____________________

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Frontline Service: Request for Endorsement for Application for Establishment, Operation of Radiation Emitting Apparatus (X-ray facilities - Free Standing) Clients: Hospitals, Clinics, Laboratories Requirements:

FOR NEW APPLICANTS: Duly accomplished license application form with corresponding license fee

1. Contract of employment of radiologist and radiologist x-ray technologist 2. Certificate of training of doctor if he/she is not a fellow of Philippine College of Radiology 3. Photocopy of PCR certificate and PRC license of radiologist (if diplomat or fellow) 4. Photocopy of PRC license of radiologic/X-ray technologist 5. Certificate of training in radiation protection of radiologic/x-ray technologist if she actsas Radiation Safety Officer 6. Photocopy of business/mayor’s permit and SEC registration certificate 7. Application form 8. Documents for compliance in case there are findings during inspection

FOR RENEWAL for renewal process is on the RLEC part the application must be complete to renew their application of X-ray. If compliance is required:

1. Duly accomplished license application form with corresponding license fee 2. Photocopy of the Official Receipt of the personnel dose monitor (film, TLD, or OSL) from the provider of personnel dose monitoring services. 3. Photocopy of personnel dose reports within the validity period of the previous license. 4. Duly filled-up and notarized affidavit of continuous compliant 5. Photocopy of the latest License TO Operate.

If non-compliant:

1. Notarized certificate of compliance 2. Proof of compliance: pictures, receipts, charts, logbook 3. Contract of employment of radiologist or radiologic technologist 4. Documents required by Center for Device, Regulation, Radiation Health and Research as specified in the Checklist


Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees: Total Processing Time:1 hour and 35 minutes

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Receive application forms and documents

Food and Drugs Administration/ Food and Drug Regulation Officer

Ground Fl., Annex Bldg, DOH ARMM ORG Compound

5 minutes

Review and check completeness of documents



20 minutes

If complete, prepare letter of endorsement



15 minutes

Forward to the office of the Regional Secretary for Signature


Ground Fl., Annex Bldg, DOH-ARMM ORG Compound

5 minutes

Signing of the endorsement letter Office of the Regional

Secretary/ Regional Secretary

2ndFl, Admin Bldg, DOH-ARMM ORG Compound

30 mniutes

Send to FDA Section for release Office of the Regional

Secretary/ Clerk 2ndFl, Admin Bldg, DOH-ARMM ORG Compound

5 minutes

FDA packages information to Record Section for transmittal to FDA Central Office



10 minutes

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2

Receive notification of transmittal Inform client of the transmittal Food and Drugs Administration/ Food and Drug Regulation Officer


5 minutes

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Frontline Service: Application for License to Operate (LTO) for Food and Drug Administration (FDA) Clients: Pharmacist / Pharmacy owner, Food manufacturers owner Requirements: Submit in three (3) sets / requirements for initial Application of License to operate I. GENERAL REQUIREMENTS FOR INITIAL APPLICATION FOR LTO(FOOD ESTABLISHMENT) 1. Duly accomplished and notarized Integrated Application Form (Refer to FDA Circular No.2014-003) 2. Proof of Registration

If Single Proprietorship, valid Certificate of Business Name Registration with the Department of Trade and Industry

If Corporation or Partnership, valid Registration with Securities and Exchange Commission (SEC) and Articles of Incorporation or Partnership

If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) andby laws Note: a. If the DTI or SEC has a different Business Address, copy of valid Business/Mayor’sPermit or Barangay Clearance must be submitted b. If the Corporate Name is different from the Business Name, copy of amended SECRegistration must be submitted c. Registration must indicate the actual activity/ purpose

3. Proof of Occupancy – Manufacturing Facility /Office and/or Warehouse/ Stock Room

Valid notarized Contract of Lease / Sub-Lease/ Certificate of Occupancy/Warehousing Agreement (for Third Party Logistics)

Transfer Certificate of Title (TCT) if owned and notarized Certificate of Occupancy (if owned by one of the incorporators)

Clearance from the Condominium/ Building Administration allowing the use of the unitfor business purposes – as necessary 5. Location Plan/Site/Google Map (indicate size, location, landmarks, immediate environment,type of building) 6. Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant) 7. List of food products to be manufactured/repacked/ distributed 8. Facsimile of Proposed Label (for local manufacturer) / sample label of product to beimported/distributed 9. Secretary’s certificate (Corp./ Partnership) or Special Power of Attorney (others) if applicant is not the owner himself authorizing the applicant for the purpose II. SPECIFIC REQUIREMENTS

A. FOOD MANUFACTURER/FOOD REPACKER/EXPORTER OF OWN PRODUCTS 1. Copy of Notarized Fixed Asset & Operating Capital or Financial Statement 2. Copy of notarized valid Franchise Agreement (if franchise) 3. Organizational Chart Indicating qualification of key personnel in production and qualitycontrol 3.1 Educational Background 3.2 Trainings Attended 4. List of production equipment with specification 5. List of quality control facilities and equipment (if any)

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6. Flowchart of manufacturing process with emphasis on identification of critical control points 7. Detailed description of manufacturing process 8. Quality control procedures / sanitation standard operating procedures enforced in the plant:

8.1 Working Area 8.3 Personnel 8.2 Equipment 8.4 Pest Control Program

9. Certification with current laboratory analysis (from FDA recognized laboratories) 9.1 Source Water

9.1.1 Photocopy of recent water bill (issued by MWSS/Maynilad or provincial water district; and/or satisfactory results of portability test performed by either: 9.1.1.1 DOH Laboratory 9.1.1.2 Laboratories of Water Supplier 9.1.1.3 Laboratories accredited by DOH as per A.O. 26-A s. 1994

9.2 Finished Product’s compliance with standard Note:

For locally manufactured food product, refer to the applicable Philippine National Standard for the specific product or FDA Circular No: 2013-010 and its amendment

For bottled water, refer to AO 18-A s. 1993 for additional tests to be submitted 9.3 Packaging certification of suitability for food use except glass

10. Name and address of suppliers of raw materials and packaging materials 11. Photocopy of notarized valid contract/ agreement with the manufacturer (for Food Repacker/Toll Manufacturer only) 12. Photocopy of the License to Operate (LTO) of the Manufacturer/Source (for Food Repacker/Toll Manufacturer only)

B. IMPORTER OF RAW MATERIALS FOR OWN USE 1. Certificate of Analysis for raw materials/finished products 2. Any of the following from each supplier

Foreign Agency Agreement

Proforma Invoice 3. Any one of the following documents for the status of Manufacturer issued by the Regulatory/ Health Authority from the country of origin:

a. Certificate of Registration of Manufacturer and its conformity with GMP fromRegulatory/ Health Authority or its equivalent b. Phytosanitary Certificate/Health Certificate c. Certificate of Free Sale d. ISO 22000 Certification/FSSC 2200 e. HACCP Certificate as applicable

Note: If document is not issued by a Regulatory/ Health Authority from the country of origin, it has to be attested by the Chamber of Commerce from the country of origin or duly authenticated by the Philippine Consulate

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C. DISTRIBUTOR IMPORTER 1. Any of the following from each supplier

Foreign Agency Agreement

Certificate of Distributorship

Appointment Letter

Proforma Invoice

Memorandum of Agreement 2. Refer to B3 D. DISTRIBUTOR EXPORTER 1. Copy of valid License to Operate (LTO) of Supplier/ Manufacturer 2. Valid notarized Distributorship Agreement or Letter of Appointment with FDA licensed Supplier/ Manufacturer to distribute their products outside the Philippines 3. List of food products with registration numbers and validities E. DISTRIBUTOR WHOLESALER For Locally Procured Raw Materials in Bulk and Finished Products in original container 1. Copy of valid License to Operate (LTO) of Supplier/ Manufacturer 2. Valid notarized Distributor Agreement or Letter of Appointment with FDA licensed Supplier/ Manufacturer to distribute their products within the Philippines 3. List of food products with registration numbers and validities Subcontracts to a Licensed Manufacturer/Repacker 1. Copy of valid License to Operate (LTO) of Manufacturer and/or Repacker (tolling/ repacking activity and specific product should be indicated in the LTO) 2. Valid notarized Toll Manufacturing and/or Repacking Agreement with FDA licensed Toll Manufacturer and/or Repacker III.ADDITIONAL REQUIREMENTS – as applicable 1. For Salt Importer

For Distribution (Iodized Salt) – Certificate of Analysis for the presence of iodine conducted by the Manufacturer/Supplier in conformance with RA 8172 (ASIN Law) For Iodization – Valid LTO of the Manufacturer and notarized Memorandum of Agreement (MOA) with FDA licensed Manufacturer For Industrial use – Notarized Affidavit of Undertaking that the salt for industrial use and List of Customers indicating the name, address, contact numbers and the quantity allotted

2. For Staple Products (Wheat Flour, Cooking Oil and Rice Premixes) Importer For Distribution – Certificate of Analysis for the presence of fortificant (vitamin A and/or Iron), conducted by the Manufacturer/Supplier in conformance with RA 8976 (Phil.Food Fortification Act)

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For Fortification – Valid LTO of the Manufacturer and notarized Memorandum of Agreement (MOA) with FDA licensed Manufacturer 3. Other Food Products (Local and Imported)

Raw Materials/Food Additives: Certificate of Analysis

Soy Sauce: Certificate of Analysis for 3 MCPD (3-monochloropropane-1,2-diol)

Milk and Milk Products: Certificate of Analysis Free of Melamine Schedule of Availability of Service: Monday to Friday, 8:00 am to 5:00 pm No Noon Break

Ramadan Monday to Friday, 7:00 am to 3:00 pm

Fees: PhP 1,000.00 application fee, PhP 10.00 legal research fund Total Processing Time: 1 hour and 50 minutes except Turn Over Time of FDA Manila and Courier Time


Step No Client Step Agency Action Responsible Office/Position


1 Submit duly accomplished application form (see form on the next page)

Receive application and check completeness and authenticity of the documents submitted



30 minutes

2 Claim order of payment Issue Order of Payment Food and Drugs Administration/ Food and Drug Regulation Officer


5 minutes

3

Proceed to Cashier’s Office, present Order of Payment and pay application fee


Cashier’s Office / Cashier

2nd Floor, Admin. Bldg. DOH-ARMM, ORG Compound

10 minutes

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4 Present the Official Receipt R to the FDA

Photocopy the Official Receipt Prepare Transmittal Letter to the FDA Forward to the Chief Administrative Office for signature



20 minutes

Sign the transmittal letter

Chief Administrative Office/ Officer

1st Fl. Admin Bldg, DOH ARMM, ORG Compound

10 minutes

Send to FDA Section for release Chief Administrative Office/ Officer


5 minutes




10 minutes

Transmit to FDA Central Office via courier



1 Day Courier Time

FDA Central Office process the licensing

FDA Central Office FDA Central Office, Alabang, Muntinlupa City

1 month

Transmit License to FDA, DOH-ARMM


1 Day Courier Time

4 Receive notice of release of LTO Notify clients through phone call Food and Drugs Ground Fl., Annex Bldg, 10 minutes

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or text Administration/ Food and Drug Regulation Officer

DOH-ARMM ORG Compound

5

Receive LTO Issued LTO from FDA Central Office will be released to the owner of the establishment.



10 minutes

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I. GENERAL REQUIREMENTS FOR RENEWAL OF LTO OF FOOD

ESTABLISHMENT

CENTER FOR FOOD REGULATION AND RESEARCH CHECKLIST OF

REQUIREMENTS FOR RENEWAL APPLICATION

FOR A LICENSE TO OPERATE FOOD ESTABLISHMENT FOOD MANUFACTURER

1. Integrated Application Form (Refer to FDA Circular No. 2014-003)

2. Payment of Renewal Fee

3. Copy of Financial Statement

4. Copy of License To Operate including annex pages

FOOD DISTRIBUTOR

1. Integrated Application Form (Refer to FDA Circular No. 2014-003)

2. Payment of Renewal Fee

3. Copy of License To Operate including annex pages

*Establishment may still be inspected prior to renewal of LTO if deemed necessary These forms can be downloaded from www.fda.gov.ph

http://www.fda.gov.ph/

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Frontline Service: Application for Renewal for License to Operate (LTO) for Food and Drug Administration (FDA) Clients: Cosmetics and Household hazardous Substance Importers/Exporters/Wholesalers, Drugs Importers/Exporters/Wholesalers, Drug Store, Food Importers/Exporters/Wholesalers, Requirements: CHECKLIST REQUIREMENTS FOR DRUG RETAILER (DRUGSTORE/*RONPD)

1. Notarized Duly Accomplished Petition Form and Joint Affidavit of Undertaking (no erasures) 2. Proof of Registration; If Single Proprietorship, Certificate of Business Name Registration with the Depart. Of Trade and Industry (DTI) 3. Valid Mayors Business Permit or Barangay Business Permit bearing the exact registered business name and address of the retailer 4. If Cooperative, registration with Cooperative Development Authority (CDA) 5. If Corporation or Partnership, Registration with Securities and Exchange Commission (SEC) and Articles of Incorporation: Secretary’s Certificate

When applicable

If the Corporate Name is different from the Business Name, to reflect business name to be used in SEC Registration

If the Corporate Address is different from the Business Address, secure either Mayors Business Permit or Barangay Business Permit reflecting the exact registered business name & address

6. -If Franchise, submit a copy of Franchise Agreement and proof of registration of franchisor 7. -Pharmacist Clearance 8. -Copies of Pharmacist Board Certificate, valid PRC-ID, current PTR, Duties and Responsibilities of the pharmacist and Certificate Attendance of owner/Pharmacist to

an FDA sponsored/accredited Seminar on Licensing of Drug Establishments and Outlets (AO#56 s. 1989) and Seminar on EDPMS (NCPAM) 9. -Tentative list of products intended to be sold using generic names with brand names, if any 10. -Notarized Contract of Lease for the space occupied if not owned, or any proof of ownership if owned ( e.g. Tax Declaration) or notarized Certificate of Occupancy 11. -Valid Homeowners Association (HOA) Clearance when applicable 12. -Picture of drugstore with signboard bearing exact registered business name 13. -Floor area not less than 15 sq. meters

* Location Plan (sketch with landmark) and Floor Plan with dimension (sq. meters) of outlet (including compounding area and storage room/warehouse when applicable -Rubber stamp of outlet bearing the exact registered business name and address -Generic *White Label bearing the exact registered business name and address -LICENSING FEE based on AO#56 s. 2001 Opening/Initial (1-year validity): Php 1,000.00 + Legal Research Fee (1%)= Php 1,010.00 .

Schedule of Availability of Service: Monday to Friday, 8:00 am to 5:00 pm No Noon Break Ramadan Monday to Friday, 7:00 am to 3:00 pm

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Fees: DRUGSTORE:

DRUG IMPORTER / EXPORTER / WHOLESALER:

LTO RENEWAL

2 years

LRF 1% TOTAL

RENEWAL

2 YEARS

RENEWAL x2

MONTHS

DELAY

SURCHARGE

10% MONTH

TOTAL

SURCHARCE

GRAND

TOTAL

10,000.00 100.00 10,100.00 10,100.00 X 2 20,000.00

1 1,000.00 21,000.00 31,100.00

2 2,000.00 22,000.00 32,100.00

3 3,000.00 23,000.00 33,100.00

LTO RENEWAL 2

years

LRF 1% TOTAL

RENEWAL

2 YEARS

RENEWAL x2

MONTHS

DELAY

SURCHARGE

10% MONTH

TOTAL

SURCHARCE

GRAND

TOTAL

2,000.00 20.00 2,020.00 2,000.00

X 2

4,000.00

1 200.00 4,200.00 6,220.00

2 400.00 4,400.00 6,420.00

3 600.00 4,600.00 6,620.00

4 800.00 4,800.00 6,820.00

4 Months and above + TURNED INITIAL Opening Fee

1,010.00 + 4,800.00

5,810.00

(1 year)

48

4 4,000.00 24,000.00 34,100.00

4 Months and above + TURNED INITIAL Opening Fee = 5,050.00 24,000.00 29,050.00

COSMETICS & HHS IMPORTER / EXPORTER / WHOLESALER:

LTO

RENEWAL 2

years

LRF 1% TOTAL

RENEWAL

2 YEARS

RENEWAL x2

MONTHS

DELAY

SURCHARGE

10% MONTH

TOTAL

SURCHARCE

GRAND

TOTAL

6,000.00 60.00 6,060.00 6,000.00 X 2 12,000.00

1 600.00 12,600.00 18,660.00

2 1,200.00 13,200.00 19,260.00

3 1,800.00 13,800.00 19,860.00

4 2,400.00 14,400.00 20,460.00


FOOD IMPORTER / EXPORTER / WHOLESALER

LTO

RENEWAL 2

years

LRF 1% TOTAL

RENEWAL

2 YEARS

RENEWAL x2

MONTHS

DELAY

SURCHARGE

10% MONTH

TOTAL

SURCHARCE

GRAND

TOTAL

8,000.00 80.00 8,080.00 8,080.00 X 2 16,000.00

1 800.00 16,800.00 24,800.00

2 1,600.00 17,600.00 25,680.00

3 2,400.00 18,400.00 26,480.00

49

4 3,200.00 19,200.00 27,280.00


Total Processing Time: 1 hour and 35 minutes except Turn Over Time of FDA Manila (1 month) and Courier Time (2 days)

How to avail of the service



1 Submit duly accomplished renewal form (see form on the next page)

Receive renewal form and check completeness of the documents submitted



15 minutes



5 minutes




2nd Floor, Admin. Bldg. DOH-ARMM, ORG

Compound

10 minutes

50

4 Present the Official Receipt to the FDA




20 minutes




10 minutes



5 minutes




10 minutes




1 Day Courier Time



1 month



1 Day Courier Time

4 Receive notice of release of renewed Notify clients through through Food and Drugs Ground Fl., Annex Bldg, 10 minutes

51

of LTO phone call or text Administration/ Food and Drug Regulation Officer

DOH-ARMM ORG Compound

5

Receive renewed of LTO Issued LTO from FDA Central Office will be released to the owner of the establishment.



10 minutes

52

Frontline Service: Application for Reissuance of Lost/Damaged License to Operate Clients: Pharmacist / Pharmacy owner, Food manufacturers owner Requirements: Submit 2 sets of copies:

1. Letter request of owner/manager for re-issuance/lost LTO, Addressed to Secretary of Health-ARMM

2. Surrender original LTO/Affidavit of loss (notarized) 3. Updated DTI 4. Photocopy of renewal payment (O.R) 5. Pharmacist’s documents

Valid PRC-ID

Valid PTR

Board Certificate

Certificate of attendance to FDA Licensing Seminar

_Pharmacist clearance 6. Joint affidavit of undertaking (notarized) w/ documentary stamp 7. I.D. picture of Pharmacist 2pcs (2X2)


Ramadan Monday to Friday, 7:00 am to 3:00 pm

Fees: PhP500.00 application fee, PhP 10.00 legal research fund Total Processing Time: 1 hour and 40 minutes except Turn Over Time of FDA Manila (1 month) and Courier Time (2 days)




53

1 Submit letter of request and other requirements (see form on the next page)

Receive letter of request and check completeness and authenticity of the documents submitted



10 minutes



5 minutes




2nd Floor, Admin. Bldg. DOH-ARMM, ORG

Compound

10 minutes

4 Present the Official Receipt R to the FDA




20 minutes




10 minutes



5 minutes


Food and Drugs Administration/ Food and Drug Regulation


10 minutes

54

Officer




1 Day Courier Time



1 month



1 Day Courier Time

4 Receive notice of reissuance of LTO Notify clients through phone call or text



10 minutes

5

Receive reissued LTO Release reissued LTO from FDA Central Office will be released to the owner of the establishment.



10 minutes

55

Frontline Service :Request for Change of Pharmacist Clients : Drug Stores, Hospital Pharmacies Requirements: Checklist of Requirements for the Change of Pharmacist Submit 2 sets of copies: Incoming Pharmacist

1. Notice of Change of Pharmacist Form

2. Copy of PRC-ID, PTR, PRC-Board Certificate

3. I.D picture 2pcs. (2X2)

4. FDA licensing seminar certificate of attendance

5. Pharmacist Clearance

6. Surrender original license to Operate (LTO)

Outgoing Pharmacist

1. Resignation from previous employment signed by employer Schedule of Availability of Service: Monday to Friday, 8:00 am to 5:00 pm No Noon Break

Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees: PhP 500.00 application fee, PhP 10.00 legal research fund Total Processing Time: 1 hour and 30 minutes except Turn Over Time of FDA Manila (1 month) and Courier Time (2 days)



Location of Office Maximum Duration of

Step

56

1 Submit duly change of pharmacist form and all requirements (see form on the next page)

Receive change of pharmacy form and check completeness of the documents submitted



10 minutes



5 minutes



Cashier’s Office / Cashier 2nd Floor, Admin. Bldg. DOH-ARMM, ORG Compound

10 minutes





20 minutes




10 minutes



5 minutes




10 minutes




10 minutes

57



5 minutes




10 minutes




1 Day Courier Time

FDA Central Office process the

change of pharmacist FDA Central Office FDA Central Office,

Alabang, Muntinlupa City 1 month

Transmit change of pharmacist to

FDA, DOH-ARMM FDA Central Office FDA Central Office,

Alabang, Muntinlupa City 1 Day Courier Time

4 Receive notice of change of pharmacist




10 minutes

5

Receive change of pharmacist Issued change of pharmacistfrom FDA Central Office will be released to the owner of the establishment.



10 minutes

58

Frontline Service: Request for Approval of Transfer of Location of the Drugstores Clients: Drug Stores Requirements: Checklist of Requirements for Transfer of Location Submit 2 sets of copies:

1. Letter of Intent regarding the transfer of location

2. If single Proprietorship, DTI cert. replicating the new business address and Articles of Incorporation/Partnership and /or Mayor’s permit/Business permit reflecting the

new business address.

3. Lease of Contract (office & warehouse) or Cert. of ownership if owned

4. Location Plan with landmark & Floor Plan with dimension-Sketch only (Office/Warehouse)

5. Surrender original license to Operate (LTO)/Affidavit of loss notarized

Additional Requirements: Drugstore:

1. Picture of the Drugstore with permanent Sign Board

2. Red and White Generic Label (except CDS)

3. Rubber Stamp of name and address of establishment

Distributor: 1. Letter received by supplier informing the transfer of ocation


Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees: PhP 500.00 application fee, PhP 10.00 legal research fund Total Processing Time: 2 hours except Turn Over Time of FDA Manila (1 month) and Courier Time (2 days)



Location of Office Maximum Duration of

59

Step

1 Submit letter of intent form and all requirements (see form on the next page)

Receive letter of intent and check completeness of the documents submitted



10 minutes



5 minutes



Cashier’s Office / Cashier 2nd Floor, Admin. Bldg. DOH-ARMM, ORG Compound

10 minutes





20 minutes




10 minutes



5 minutes




10 minutes




1 Day Courier Time

60

FDA Central Office process the

change of pharmacist FDA Central Office FDA Central Office,

Alabang, Muntinlupa City 1 month

Transmit transfer of location

request to FDA, DOH-ARMM FDA Central Office FDA Central Office,

Alabang, Muntinlupa City 1 Day Courier Time

Draft letter of approval of transfer of location Forward to the Chief Administrative Office for signature



30 minutes

Signing of the letter of approval of transfer of location



5 minutes

4 Receive notice transfer of location Notify clients through phone call or text



5 minutes

5

Receive approval letter of transfer of location

Issued change of pharmacist from FDA Central Office will be released to the owner of the establishment.



10 minutes

61

Frontline Service: Application for Smoking Cessation Counseling Clients: Individuals Referred from Private Clinics/OPD or Walk-in Clients Requirements:

1. For the referred client - with or without Referral Slip Schedule of Availability of Service: Monday to Friday, 8:00 am to 5:00 pm No Noon Break

Ramadan Monday to Friday, 7:00 am to 3:00 pm Fees: No fees required Total Processing Time: 30-45 minutes


Step No Client Step Agency/ LGU Action

Responsible Office/ Position


1. Registration at the Smoking Cessation Clinic

Record registration Smoking Cessation Clinic Section / Nurse Coordinator

Ground Floor, Training Center Building, DOH-ARMM, ORG Compound Cotabato City

5 minutes

2. Client provide smoking history and profile

Interview the client to determine smoking history

Smoking Cessation Clinic Section / Nurse Coordinator


30 minutes

3. Receive counseling session Conduct counseling session

Smoking Cessation Clinic Section/ Nurse Coordinator


1 hour

4. Schedule of next visit of the Client Provide available date for client follow-up

Smoking Cessation Clinic Section / Nurse Coordinator


5 minutes

62

Procedure of filing complaints / Feedback and/or Complaints Form

Public Assistance Desk

Please let us know how we have served you by doing any of the following:

Accomplish our Feedback Form available in the office and put into the drop box “suggestion & comments box”.

Send you feedback through email([email protected] ) or txt us at 0920-909-1094

Talk to our Officer of The Day.

Redress Mechanism

Should there be any failure on the part of DOH-ARMM to meet the requirements of the Citizen’s Charter, the agency shall issue an official apology at the minimum. Other types of redress shall be considered based on the gravity and impact of the failure to comply with the conditions of the charter. SUKRAN for helping us continuously improve our service.

63

Feedback Forms

MAMAYAN MUNA, HINDI MAMAYA NA

____________________

Date (Petsa)

Name of Commending Party ___________________________ Tel/Fax/Cellphone No. ________________ (PangalanngNagbibigayPapuri) (Telopono) Office/Address: ________________________________________________________________________ (Tanggapan/Tirahan)

Residence /Address: ____________________________________________________________________ (Tirahan)

Name of Person being Commended:________________________________________________________ (PangalanngPinapurihan) Position/Office:________________________________________________________________________ (Katungkulan/Tanggapan)

Particulars Commendation (DahilanngPapuri)_______________________________________________ _____________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________

_____________________________________________________________________________________

___________________________________

Signature (Lagda)

You may use the back page for additional information. (Maaaringgamitinanglikuranngpapel Para sakaragdaganginpormasyon).

FORM NO 1 – COMMENDATION (PAPURI)

64


____________________

Date (Petsa) Name of Commending Party ___________________________ Tel/Fax/Cellphone No. ________________ (PangalanngNagbibigayPapuri) (Telopono) Office/Address: ________________________________________________________________________ (Tanggapan/Tirahan)

Residence /Address: ____________________________________________________________________ (Tirahan)

Particulars of Request ( DetalyengPaghingingtulong) _______________________________________ _____________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

___________________________________ Signature (Lagda)


FORM NO 2– REQUESTING FOR ASSISTANCE

(PaghingingTulong)

65


____________________

Date (Petsa) Name of Commending Party ___________________________ Tel/Fax/Cellphone No. ________________ (PangalanngNagbibigayPapuri) (Telopono) Office/Address: ________________________________________________________________________ (Tanggapan/Tirahan)

Residence /Address: ____________________________________________________________________ (Tirahan) Name of Person being Complained of_______________________________________________________ (PangalanngTaongNirereklamo) Position/Office:________________________________________________________________________ (Katungkulan/Tanggapan)

Particulars Complaint(DetalyengReklamo)_________________________________________________ _____________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________

_____________________________________________________________________________________

___________________________________

Signature (Lagda)



FORM NO 3 – COMPLAINT (Reklamo)

(PAPURI)

66

____________________

Date (Petsa)

Name of Commending Party ___________________________ Tel/Fax/Cellphone No. ________________ (PangalanngNagbibigayPapuri) (Telopono) Office/Address: ________________________________________________________________________ (Tanggapan/Tirahan) Residence /Address: ____________________________________________________________________ (Tirahan)

Recommendations / Suggestions (Mungkahi / suhestiyon)_______________________________________

_____________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________

_____________________________________________________________________________________

___________________________________

Signature (Lagda)


FORM NO 4 – RECOMMENDATION

(Mungkahi)

67

Customer Feedback Form

Thank you for visiting DOH-ARMM and availing of our services. Because we want to serve you better, please answer the questions relevant to your visit:

1. Name:

2. Address:

3. Department/Office Visited:

4. Service Availed:

OUR OFFICE

5. Is the office easy to locate?

6. Is the office clean and orderly?

7. Did you feel comfortable?

8. Was there a long waiting line of customers?

9. Was there an appropriate signage of direction?

OUR FRONTLINERS

10. Is the employee-in-charge available?

11. Is the employee-in-charge knowledgeable?

12. Is the employee-in-charge accommodating?

13. Were you received properly?

14. Were your needs attended to promptly?

15. Were you made to wait long?

REQUIREMENTS

16. Were you made aware of the requirements?

17. Was there so many additional requirements?

18. Were you given proper information on how to get requirements?

19. Were you made aware of the fees you will pay?

OUR OFFICERS

20. Were the authorized official/s available?

21. Did it take him/them long to sign the document?

22. Nagpa-importanteba?

OUR INFORMATION

23. Is the document needed available?

24. Is the document well-organized?

25. Is the data complete?

26. Is the data relevant to

NOO

YES

68

your request?

27. Are instructions clear, brief and concise?

Other Comments/Suggestions:

Thank you very much.

Automatic Extension of Licenses, Permits and Authorities If the government office or agency fails to act on an application and/or request for renewal of a license, permit or authority subject to renewal within the prescribed period, said permit, license or authority shall automatically be extended until a decision or resolution is rendered on the application for renewal. In this instance, the applicant shall be informed prior to the expiration of the original period that more time is required to evaluate the application or request. No automatic extension or extension shall apply to an expired permit, license, or authority covers activities which pose danger to public health, public safety, public morals, or public policy including but not limited to, national resource extraction activities. (Rule VI, Section 6 of Republic Act No. 9485, “An Act to Improve Efficiency in the Delivery of Government Service to the Public by Reducing Bureaucratic Red Tape, Preventing Graft and Corruption, and Providing Penalties Therefor”)