General Licensing Procedure (doh) 3qc60
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General Licensing Procedures CERTIFICATE OF NEED
PERMIT TO CONSTRUCT
INITIAL LICENSE TO OPERATE
RENEWAL OF LICENSE TO OPERATE
Step 1: Certificate of Need (CON) (istrative 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
1
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) ( istrative 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
2
(Additional Requirements for New General Hospitals) Zoning Certificate or Location Clearance from the Municipal Planning & Development Office (MPDO) CHD’s 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.
3
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) 4
Approved Board Resolution (for local government laboratory) Mayor’s 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 ed address with DTI/SEC is different from the address of the establishment to be licensed, submit a photocopy of the Business/Mayor’s 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)
5
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 tly 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 t 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 Mayor’s/Business Permit Board Certificate PRC ID PTR Certificate of Attendance (Licensing Seminar)Duties and Responsibility (Distributor) Applicable fee
6
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.
7
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)
8
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.
9
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)
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
12
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)
14
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
16
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
18
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
20
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
21
PERMIT TO CONSTRUCT
INITIAL LICENSE TO OPERATE
RENEWAL OF LICENSE TO OPERATE
Step 1: Certificate of Need (CON) (istrative 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
1
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) ( istrative 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
2
(Additional Requirements for New General Hospitals) Zoning Certificate or Location Clearance from the Municipal Planning & Development Office (MPDO) CHD’s 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.
3
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) 4
Approved Board Resolution (for local government laboratory) Mayor’s 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 ed address with DTI/SEC is different from the address of the establishment to be licensed, submit a photocopy of the Business/Mayor’s 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)
5
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 tly 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 t 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 Mayor’s/Business Permit Board Certificate PRC ID PTR Certificate of Attendance (Licensing Seminar)Duties and Responsibility (Distributor) Applicable fee
6
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.
7
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)
8
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.
9
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)
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
12
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)
14
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
16
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
18
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
20
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
21
Related Documents 3h463d
General Licensing Procedure (doh) 3qc60
December 2019 50
General Dentist Licensing Requirements 235v3r
December 2019 70
General Dispensing Procedure 5p2p6s
November 2019 55
General Earthwork Procedure 6l4vr
December 2019 44
December 2019 29
