Académique Documents
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CERTIFICATE OF NEED
PERMIT TO CONSTRUCT
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.
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)
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)
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
10
ONE STOPSTOP-SHOP
LICENSING PROCEDURES
I. CERTIFICATE OF NEED
Certificate of Need
(New General Hospital)
1)
2)
3)
4)
5)
6)
11
7)
YES
Approved CON?
NO
12
Permit to Construct
(Hospital/Clinical Laboratory/HIV/Blood Bank/Dental Laboratory/
X-Ray Facility)
1)
2)
3)
4)
5)
6)
13
7)
Approved PTC?
YES
NO
Need for
Re-evaluation Fee?
NO
(go to #6)
YES
(go to #3)
14
1)
2)
3)
4)
5)
6)
7)
Inspection/survey of facility
15
8)
YES
Facility compliant to
standards?
NO
Client requests
for facility reinspection
YES
NO
Back to step #3
CHD issues initial LTO to
client
16
Inspection/survey of facility
17
Facility compliant to
standards?
YES
NO
Client requests
for facility reinspection
YES
NO
Back to step #3
CHD issues initial LTO to
client
18
1)
2)
3)
4)
5)
6)
7)
Inspection/survey of facility
19
8)
YES
Facility compliant to
standards?
NO
YES
NO
Back to step #3
CHD endorses LTO
application to BFAD
20
21