General Licensing Procedures

CERTIFICATE OF NEED

PERMIT TO CONSTRUCT

INITIAL LICENSE TO OPERATE

RENEWAL OF LICENSE TO OPERATE

Step 1: Certificate of Need (CON)

(Administrative Order #2006-0004)

Required for new general hospitals

Required for permit to construct (PTC) applications for the conversion or
upgrading of a birthing home into a general hospital, or a special hospital
into a general hospital

The establishment of new special hospitals, sanitaria, Department of
National Defense hospitals, Philippine National Police hospitals,
penitentiary hospitals, and research hospitals shall be exempted from the
CON

Validity period is 6 months. Within this period, the permit to construct
(PTC) application must be received by the RLED.
Requirements:
Hospital

Application form for certificate of need for new hospitals

Certification from Provincial Planning and Development Office that the
proposed hospital is part of the duly approved Provincial
Hospital/Healthcare Delivery Plan (if available).

Applicable Fee

Procedure:
Hospital
1. Client gets application form from CHD or DOH website.
2. Client applies for CON/ submits complete documentary requirements to
RLED.
3. RLED staff issues order of payment to client.
4. Client pays CON application fee at the cashier.
5. Client submits Order of Payment with OR Number to RLED staff.
6. Regional Health Facility Establishment Review Committee (HFERC)
evaluates CON application.
7. A. If application for CON is approved, CHD issues CON to client B. If not
approved, RLED informs the client on reason for the disapproval of
application.

Step 2: Permit to Construct (PTC)

( Administrative Order # 2006-0004-A)
- Filed at the Bureau of Health Facilities and Services

Required for construction of a new hospital or other health facility; substantial
alteration, expansion or renovation of an existing health facility or increase in
bed capacity.

A prerequisite for a license to operate (LTO).

Validity period is one year. Within this period, the application for initial
license to operate must be received by the Bureau of Health Facilities and
Services
If the PTC expires (i.e. the work does not commence within 365 days from the
issuance of PTC), a CON shall be required if the applicant decides to apply for a
new PTC
Requirements:
Hospital

Letter of application to the Director of the Bureau of Health Facilities and
Services

Form No. 1-01: Application for Permit to Construct

Letter of endorsement from the Director of the Bureau of Health Facilities
and Services

Four (4) sets of Site Development Plans and Floor Plans signed and sealed
by an architect and/or Engineer

Applicable Fee

(Additional Requirements for New General Hospitals)

Zoning Certificate or Location Clearance from the Municipal Planning &
Development Office (MPDO)

CHDs Recommendation for Certificate of Need to establish a hospital

DTI/SEC Registration (for private health facilities)

Enabling Act (for National Government Hospitals)

Approved Sanggunian Resolution (for Local Government Hospital)

Environmental Compliance Certificate from the DENR Environmental
Management Bureau Regional Office (for primary care, secondary care,
and tertiary care hospitals)

Waste Management Plan
Clinical Laboratory

Letter of Application to the Director of the Bureau of Health Facilities and
Services

Letter of endorsement from the Director of the Bureau of Health Facilities
and Services

Form No. 4-01: Application for Permit to Construct (notarized)

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)

Applicable Fee
Procedure:
Hospital/Clinical Laboratory
1. Client gets application form from BHFS, CHD or DOH website.
2. Client applies for PTC from the Bureau of Health Facilities and Services
and submits complete documentary requirements.
3. BHFS staff issues Order of Payment to client.
4. Client pays PTC application fee at the cashier.
5. Client submits Order of Payment with OR Number to BHFS staff.
6. HFERC evaluates the PTC application.
7. A. If application for PTC is approved, CHD staff issues PTC to client
B. If application for PTC is disapproved:
BHFS informs client on the reason for the disapproval of the
application.
Client complies and requests for PTC re-evaluation.
- If there is a need for re-evaluation fee go back to step 3.
- If there is no need for re-evaluation fee go back to step 6.

Step 3: Initial License to Operate

Required for operation of a hospital or other health facility. It is secured after
construction and completion of a hospital or other health facility.


If not renewed for a period of one (1) year it will be considered lapsed.

Validity period:
Hospitals and clinical laboratories: 1 year
Dental laboratories: 3 years
Food Manufacturer/Re-packer: 1-2 yrs
Food Establishment: 1-2 yrs
Drug Establishment:1-2 yrs
Requirements:
Hospital Filed at the Bureau of Health Facilities and Services

Letter of application and request for Inspection to the Director of the
Bureau of Health Facilities and Services

Form No. 2-01: Application Form for License to Operate a Hospital
(notarized)

List of Personnel w/ photocopies of the proofs of qualification

List of equipment/instrument

Location map of the hospital (interior and exterior)

Pictures of the hospital (exterior and interior)

Documentary requirements for initial license of other services provided by
the hospital as applicable

Certificate of Occupancy from the Office of the Building Official in the
Locality

Fire Safety Inspection Certificate from the Bureau of Fire Protection in the
Locality

Environmental Compliance Certificate

Waste Management Plan

Sanitary Certificate from the Local Health Office

Applicable Fee
Clinical Laboratory

Notarized Application for License to Operate a Clinical Laboratory

List of Personnel

Photocopies of proof of qualification and employment of the medical and
paramedical staff

List of equipment/instrument

Location map for the clinical laboratory building

SEC/DTI Registration (for private clinical laboratories) OR Issuance or Board
Resolution (for government clinical laboratories)

Quality Manual of Clinical Laboratory

Applicable Fee
Drug Testing Laboratory (Initial Certificate of Accreditation)

BHFS Application Form filed either at the Bureau

Letter of Endorsement to the Bureau Director (if filed at the CHD)
DTI/SEC Registration (for private laboratory)
Enabling Act (for national government laboratory)
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Approved Board Resolution (for local government laboratory)

Mayors Permit

One (1) set Floor Plan showing specific location of equipment and work areas
required, appropriately dimensioned, properly identified and completely
labeled. (signed and sealed by an architect or engineer).

List of Personnel, notarized, including photocopies of current PRC
identification cards and certificates of training

List of Equipment with specifications

Contract of Lease (if facility is rented)

Procedure Manual

Custody and Control Form

Applicable Fee
Dental Laboratory

Notarized application form

List of personnel
List of equipment/instrument
2x2 picture of owner, dentist, and/or dental technologist
Photocopy of PRC certificate of Registration and PRC Identification Card of
dentist and/or dental technologist
Photocopy of Certificate of Training/record of work experience
Photocopy of DTI/SEC Registration (for private dental laboratory) or
Issuance/Board Resolution (for government laboratory)
Vicinity map showing location and landmarks of the dental laboratory
Laboratory layout with appropriate labels indicating set-up of the dental
laboratory and location of the areas/rooms
Applicable Fee

Food Establishment (Manufacturer, Distributor, Exporter/Importer)

Information as to activity/ies of establishment

Notarized accomplished Petition Form
ID picture of owner/authorized representative (5cm x 5cm)
Photocopy of business name registration
A. Single Proprietorship, registration form DTI
B. Corporation/Partnership, registration from SEC and Articles of
Incorporation
Note:
A. If the registered address with DTI/SEC is different from the address
of the establishment to be licensed, submit a photocopy of the
Business/Mayors Permit
B. If the establishment adopts another business name/style different
from the corporation name, submit registration of the business
name/style with DTI.

Photocopy of notarized valid Contract of Lease of the space/building occupied

(if it is not owned)


Photocopy of notarized Fixed Asset and Operating Capital or Financial

Statement, if available

Location Plan/Site (indicate size, location, immediate environment, type of
building)

List of products to be processed/repacked/imported

Photocopy of the notarized Franchise Agreement (for franchise only)
Additional Requirements:
A. Re-packer:

Photocopy of the notarized valid Contract/Agreement with the
manufacturer with stipulation that both are jointly responsible for the
quality of the product.

Photocopy of the License to Operate (LTO) of the manufacturer.
B. Importer of Raw Materials/Finished Products in Bulk:

Photocopy of Foreign Agency Agreement duly authenticated by the
Territorial Philippine Consulate

Photocopy of Certificate of Status of Manufacturer (CGMP Certificate)
issued by a government Health Agency duly authenticated by the
Territorial Philippine Consulate.
Drug Establishment

ID Picture (Owner/Pharmacist)
Notarized Petition (refer to page 29)
Notarized Joint Affidavit of Undertaking (refer to page 29)
Valid DTI/SEC Registration
Contract of Lease/Cert. of Ownership (Office/Warehouse)
Location Plan (Office/Warehouse)
Floor Plan (Office/Warehouse)
List of Products
Pharmacist credentials
PRC Board Certificate
Valid PRC I.D.
Current year PTR
Certificate of Attendance (A.O. #56)
Duties & Responsibilities
Mayors/Business Permit
Board Certificate
PRC ID
PTR
Certificate of Attendance (Licensing Seminar)Duties and Responsibility
(Distributor)
Applicable fee

Additional Requirements:
A. Drugstore:

Picture of drugstore w/ signboard

Drugstore stamp

White Label/Red Label
B. Distributor/Wholesaler:

Notarized and valid contract w/ licensed supplier

BFAD LTO of supplier

Valid Certificate of Product Registration
C. Exporter:

Authenticated FAA

GMP Certificate/Status of Manufacturer/ISO (MD)

Proforma Invoice (non-exclusive)
Procedure:
Hospital/Clinical Laboratory
1. Client gets application form from BHFS, CHD or DOH website.
2. Client applies for Initial LTO from the Bureau of Health Facilities and
Services and submits application with complete documentary requirements.
3. BHFS staff issues Order of Payment to client.
4. Client pays application fee at the cashier.
5. Client submits Order of Payment with OR Number to BHFSstaff.
6. CHD staff officially receives complete application for LTO and schedules
inspection within 30 working days.
7. Inspection/survey of the facility.
If facility is compliant to standards:
BHFS staff issues initial LTO to client
If facility is not compliant to standards:
BHFS staff informs client on the deficiencies and disapproval of
application thru letter.
Client complies and informs CHD.
If there is need for re-inspection:
Client requests for facility re-inspection
Go back to step 3
If there is no need for facility re-inspection BHFS issues initial LTO to client
Drug Testing Laboratory

Applicant accomplishes the required documents and submits them to the
Bureau or CHD for endorsement to the Bureau. Upon filing of the application,
the applicant pays the corresponding fees to the cashier of the DOH in person,
or through postal money order.

Dental Laboratory
1. Client gets application form from CHD or DOH website.
2. Client applies for Initial LTO from RLED and submits complete documentary
requirements.
3. CHD staff issues Order of Payment to client.
4. Client pays application fee at the cashier.
5. Client submits Order of Payment with OR Number to CHD staff.
6. CHD staff officially receives complete application for LTO and schedules
inspection within 45 days.
7. Inspection/survey of the facility
If facility is compliant to standards:
CHD issues initial LTO to client
If facility is not compliant to standards:
CHD informs client of the deficiencies and the disapproval of
application.
Client complies and informs CHD
If there is need for re-inspection:
Client requests for facility re-inspection
Go back to step 3
If there is no need for facility re-inspection CHD issues initial LTO to client.
Food/Drug Establishment
1. Client gets application form from CHD or DOH website.
2. Client applies for Initial LTO and submits application with complete
documentary requirements.
3. Order of Payment issued to client.
4. Client pays Initial LTO application fee at the cashier.
5. Client submits Order of Payment with OR Number to CHD.
6. CHD staff officially receives complete application for LTO and schedules
inspection within 30 days.
7. Inspection/surveillance of the facility.
8. If facility is compliant to the standards, CHD endorses application to BFAD
If facility is not compliant to standards:
CHD informs client of deficiencies and disapproval of application.
Client complies and informs CHD.
If there is need for re-inspection:
Client requests for facility re-inspection.
Go back to step 3
If there is no need for facility re-inspection CHD endorses LTO application to
BFAD. (BFAD will release LTO)

Step 4: Renewal of License to Operate

Requirements:
Hospital

Notarized Application Form for Renewal of LTO

Sworn Statement that the hospital is compliant to the DOH standards and
technical requirements

Statistical Report

List of Personnel (for newly hired staff)

List of instruments/equipment (if with changes only)

Annual statistics report (Compute correctly for occupancy rate, average
patients/day; Diagnosis/Diseases must be translated to ICD-10)

Fire Safety Certificate for the year

Sanitary Permit (for those with dietary services)

Water Source Analysis Report (updated)

Laboratory, X-Ray and Pharmacy LTO (Photocopies) OR Affiliation
Contracts with Primary Laboratories and X-Ray facilities for Level 1
Hospitals without Clinical Laboratory and X-Ray; with Secondary
Laboratories for Level 2 Hospitals with Primary Laboratories

Applicable fee
Clinical Laboratory

Notarized Application for License to Operate a Clinical Laboratory

List of Personnel (changes only)

Photocopies of proof of qualification and employment of the medical and
paramedical staff

List of equipment/instrument (changes only)

Quality Manual of Clinical Laboratory

Certificate of Participation in External Quality Assurance Program

Applicable Fee
Dental Laboratory

Notarized application form

List of personnel
List of equipment/instrument
Photocopy of current PRC Identification Card, if applicable
Photocopy of current DTI Registration, if applicable
Applicable Fee

Procedure:
Hospital/Clinical/HIV/ Blood Bank/ Dental Laboratory/X-ray Facility
1. Client gets application form from CHD or DOH website.

2. Client applies for Initial LTO from CHD and submits complete application
with documentary requirements.
3. CHD staff issues Order of Payment to client.
4. Client pays at the cashier.
5. Client submits Order of Payment with OR Number to CHD.
6. CHD staff officially receives complete application for LTO.
If facility is compliant to standards:
RLED staff issues initial LTO to client
If facility is not compliant to standards:
RLED staff informs client on the deficiencies.
Client complies and informs CHD.
Upon receipt of complete requirements, RLED issues LTO to client

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ONE STOPSTOP-SHOP
LICENSING PROCEDURES

I. CERTIFICATE OF NEED
Certificate of Need
(New General Hospital)

1)

Client gets application form from:

A. CHD
B. DOH website

2)

Client applies for CON/submits

complete documentary
requirements to the CHD

3)

RLED staff issues Order of

Payment to client

4)

Client pays CON application fee at

the cashier

5)

Client submits Order of Payment

with OR Number to CHD staff

6)

Evaluation of CON application

by HFERC

11

7)

YES

CHD issues CON to

client

Approved CON?

NO

CHD informs client on

disapproved application

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II. PERMIT TO CONSTRUCT

Filed at the Bureau of Health Facilities and Services

Permit to Construct
(Hospital/Clinical Laboratory/HIV/Blood Bank/Dental Laboratory/
X-Ray Facility)

1)

Client gets application form from:

A. CHD
B. DOH website

2)

Client applies for PTC from the

CHD and submits complete
documentary requirements

3)

CHD staff issues Order of Payment

to client

4)

Client pays PTC application fee at

the cashier

5)

Client submits Order of Payment

with OR Number to CHD

6)

Evaluation of CON application by

HFERC

13

7)

Approved PTC?

YES

NO

CHD issues PTC to

client

CHD informs client on

disapproved application

Client complies and

requests for PTC reevaluation

Need for
Re-evaluation Fee?

NO
(go to #6)

YES
(go to #3)

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III. INITIAL LICENSE TO OPERATE

Initial License to Operate
(Hospital)
- Filed at the Bureau of Health Facilities and Services

1)

Client gets application form from:

A. CHD
B. DOH website

2)

Client applies for Initial LTO from

the CHD and submits complete
application

3)

CHD staff issues Order of Payment

to client

4)

Client pays Initial LTO application

fee at the cashier

5)

Client submits Order of Payment

with OR Number to CHD staff

6)

CHD officially receives complete

application for LTO and schedules
inspection

7)

Inspection/survey of facility

15

8)
YES

Facility compliant to
standards?

CHD issues Initial LTO

to client

NO

CHD informs client of

deficiencies and disapproved
application thru letter

Client complies and

informs CHD

Client requests
for facility reinspection

YES

Need for re-inspection?

NO
Back to step #3
CHD issues initial LTO to
client

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Initial License to Operate

(Dental Laboratory)
Client gets application form from:
A. CHD
B. DOH website

Client applies for Initial LTO and

submits complete documentary
requirements

CHD staff issues Order of Payment

to client

Client pays at the cashier

Client submits Order of Payment

with OR Number to CHD staff

CHD officially receives complete

application for LTO and schedules
inspection

Inspection/survey of facility

17

Facility compliant to
standards?

YES

CHD issues Initial LTO to

client

NO

CHD informs client on

deficiencies and
disapproved application

Client acts on deficiencies

after receipt of Notice of
Deficiencies

Client requests
for facility reinspection

YES

Need for re-inspection?

NO
Back to step #3
CHD issues initial LTO to
client

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Issuance/Re-Issuance of License to Operate

(Food/Drug Establishment)

1)

2)

3)

4)

Client gets application form or

checklist of requirements from:
A. CHD
B. DOH website

Client applies for Initial LTO and

submits application with complete
set of documentary and technical
requirements

Submitted requirements are

complete order of payment issued
to client

Client pays at the cashier

5)

Client submits Order of Payment

with OR Number to CHD

6)

CHD officially receives complete

application for LTO and schedules
inspection

7)

Inspection/survey of facility

19

8)
YES

Facility compliant to
standards?

NO

CHD informs client on

deficiencies and gives
recommendation

CHD endorses documents

to BFAD

BFAD issues initial LTO

Corrective action done by

client

Client requests for reinspection

Client requests for

facility re-inspection

YES

Need for re-inspection?

NO
Back to step #3
CHD endorses LTO
application to BFAD

BFAD issues initial LTO

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IV. RENEWAL OF LICENSE TO OPERATE

Renewal of License to Operate
(Hospital/Clinical Laboratory/HIV/Blood Bank/Dental Laboratory/
X-Ray Facility)

Client gets application form from:

A. CHD
B. DOH Website

Client applies for Renewal of LTO

to the CHD and submits complete
application

RLED staff issues Order of

Payment to client

Client pays CON application fee at

the cashier

Client submits Order of Payment

with OR Number to CHD staff

CHD officially receives complete

application for LTO

If facility is compliant to standards,

CHD issues LTO to client

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