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Public Assistance Information and Receiving

In pursuant to FDA Circular No. 2014-003: Filing and Receiving of Registration, Licensing and Other Applications Using the Integrated Application Form, the following are the steps of the LTO and CPR Processing

  • Download. Application form is downloaded from www.fda.gov.ph. The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amendments and other certifications. Promos and advertisements are also now covered in the application form. Remember that a valid LTO is required for a CPR.
  • Fill up Form. Application form is filled up correctly. The application form has six parts: 1) General Information, 2) Establishment Information, 3) Product Information, 4) Supporting Information, 5) Sources and Clients, and 6) Applicant Information. If the part is appropriately filled up, a green ‘PROCEED’ will be indicated.Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
  • Email. Send an email to [email protected]. In the XLS application form, the worksheet ‘Email’ composes the subject and body of the email that should be sent to [email protected]. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
  • Scheduling. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission. The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be scheduled over separate days. Requests for specific schedules will not be accommodated. Receiving will be scheduled within 10 working days of receipt of application email.
  • Pay. Fees are paid either at Land Bank branches or at the main FDA cashier. Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines, The main FDA cashier will only accommodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
  • Check. Check if all requirements are in order. Be sure that you have a checklist of requirements and that you have all the necessary documents. Don’t forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
  • Submission. Application is filed in on schedule. Only applications scheduled for the day will be accommodated. Hard copies will no longer be required at submission. Don’t forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through [email protected]. Should you fail to complete submission on the set date, queue for another schedule through [email protected] using the RSN.
  • Download this file (CRO and Sponsor_Integrated Application Form.xls)CRO and Sponsor_Integrated Application Form.xls
  • Download this file (CRO and Sponsor_Integrated Application Form.xlsx)CRO and Sponsor_Integrated Application Form.xlsx
  • Download this file (FDA Landbank Account Numbers.pdf)FDA Landbank Account Numbers.pdf
  • Download this file (Integrated Application Form (97-2003 Compatible).xls)Integrated Application Form (97-2003 Compatible).xls
  • Download this file (Integrated Application Form (XLSX Format).xlsx)Integrated Application Form (XLSX Format).xlsx

Center for Drug Regulation and Research

Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA)

Checklist

Self Assessment Toolkits

 Reference Materials for Drug Establishments

 

Center for Food Regulation and Research

Food Registration Requirements to secure Certificate of Product Registration

Issuances on Requirements

Forms

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Center for Cosmetics and Household Urban and Hazardous Substances Regulation and Research

  • Announcements and Advisories

*Note: This is for establishments seeking to process their excise tax collection under the Bureau of Internal Revenue during the eighteen (18) month transitory period, pursuant to BIR Revenue Regulations No. 7-2021.

  • Main Issuance
  • Announcements
  • Information, Education, and Communication Materials
  • Other Relevant Issuances

Steps for Cosmetic e-Notification v.2.0:

1.    Secure a CCRR User Account by sending a request to [email protected] following the format below:

2.    After securing the CCRR user account, log in at the FDA e-Portal (https://www.fda.gov.ph)
3.    Select “New Case” and accomplish the ASEAN Notification Form.
4.    Download the Order of Payment and assign the task to FDA Cashier.
5.    Pay the fee at any Landbank Branch or thru online Bancnet payment and wait for the Result of Application.
6.    If approved, download and  print the notice of acknowledgement.
7.    For more information, you may download the following for your reference/guidance:

Do’s and Don’ts

1.    Fields with red asterisk (*) are mandatory and shall not be left blank.
2.    DO NOT COMMIT ANY SPELLING MISTAKE, FDA won’t be liable for this.
3.    For the Restricted Ingredient, make sure to provide the function of that ingredient and its corresponding percentage.

ASEAN GUIDELINES

Laboratory Guidelines:

ASEAN Cosmetic Methods:

Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA)

Certificate of Free Sale for Cosmetics and Household Urban Hazardous Substances

1. Letter of Intent

2. Photocopy of the following

    1. Valid LTO with attachment(s)
    2. Valid acknowledged notification with complete particulars

3. Proof of payment (Php 510/product/country)

Note:  If the cosmetic formulation contains placenta ingredient, submit the following:

  1. Certificate of Origin indicating the specie, e.g. Equus caballus (horse), of the connective tissue extract, or embryo extract and/or placental protein
  2. Certificate of Analysis stating the composition of the placental protein or hormone free
  3. Certificate from Health Authority of the country of origin that the bovine is free from transmittable spongiform encephalopathy (TSE).

Center for Device Regulation, Radiation, Health and Research

Please see Issuances:

Checklist of Requirements

Forms

AO 2018-002 Requirements

Sales Promotion Requirements

General Guidelines

 

License to Operate (LTO) and Certificate of Facility Registration (CFR) for an X-ray Facility

Scope: Free-standing Clinics and Dental Facilities, New Therapeutic X-ray Facilities utilizing Linear Accelerators, Transportable X-ray Facilities and Non-medical X-ray Facilities 

Certificate of Compliance (COC) for the X-ray Facility

Scope: Medical X-ray Facilities under the DOH One-Stop Shop (OSS) Licensing System (Level 1, 2, and 3 General and Specialized Hospitals, Infirmaries, Primary Care Facilities, Ambulatory Surgical Clinics, and Medical Facility for Overseas Workers and Seafarers)

 

Certificate of Registration for Magnetic Resonance Imaging (MRI) Facilities

  • MRI Registration Form
  • Apply by sending a scanned copy of accomplished application form with supporting documents to [email protected]
 

Pre-Operational Permit for Therapeutic X-ray Facility

 

Certificate of Safety Evaluation (CSE) for Radiofrequency Radiation (RFR) Facilities

Scope: Radiofrequency emitting antennas and facilities (Indoor and Outdoor mobile phone base stations / cell sites, FM/AM and TV Stations)

 

Regulatory Standards and Requirements

Water Purification System/Device

Equipment Devices Used to Trear Sharps, Pathological and Infection Waste

General Guidelines

Common Services Laboratory

List of Accredited Laboratories 2023
I. Private Laboratories
1. ADIP Testing and Research Laboratory Inc. (ADIP TRLab Inc.)
Address : 136 B Scout Fuentebella Street, Barangay Sacred Heart, Kamuning, Quezon City, 1103
Telephone No. : (3) 410-0930 / (7) 799-2257
Fax No. : 3410-0930
E-mail : [email protected]
Contact Person : Beverly C. Leaño – Deputy Technical Director
Field of Testing : Chemical Testing
2. Ascxent Knowledge Resources Inc.
Address : Philippine Cooperative Center, No. 90 Balete Drive Extension, Quezon City 1112, Metro Manila
Telephone No. : (02)8638 5392 / 8463 4569
Fax No. : None
E-mail : [email protected] / [email protected] / [email protected]
Contact Person : Nida U. Autor – Laboratory Manager
Field of Testing : Microbiological Testing and Chemical Testing
3. CHEMPRO Analytical Services Laboratories, Inc.
Address : 2F-3F P1 Building, 131-135 Shaw Boulevard Barangay Oranbo, Pasig City
Telephone No. : (632) 8634-8600 / 8635-6773
Fax No. : (632) 8634-8600
E-mail : [email protected] / [email protected]
Contact Person : Marietta N. Bernardino – Marketing Manager / Ivorie Gayle I. Sta Ana – Administrative Manager / Ronet L. Rodriguez-Laboratory Head
Field of Testing : Chemical Testing and Microbiological Testing
4. F.A.S.T Laboratories Services and Technical Cooperative_CDO
Address : 2nd Floor, Asia United Bank Bldg., CM Recto Ave., corner Camp Alagar Road, Brgy. Lapasan, Cagayan de Oro City /2F 281 Tan-Leh Bldg., CM Recto Ave., Brgy Lapasan, CDO City
Telephone No. : 088-880-8574 / 088-852-4846 / 09173753278
Fax No. : (02)913-8848
E-mail : [email protected]
Contact Person : Ms. Lovebeth S. Mendoza-Laboratory Manager / Yehlen Salilid – Quality Assurance Manager
Field of Testing : Chemical Testing and Microbiological Testing
5. F.A.S.T Laboratories Services and Technical Cooperative_Cubao
Address : 62 20th Avenue Cubao Quezon City, 112
Telephone No. : (02)8913-0241
Fax No. : (02)8913-8848
E-mail : [email protected]
Contact Person : Ms. Evangeline B. Valdez-Laboratory Business Manager / Yehlen Salilid – Quality Manager
Field of Testing : Chemical Testing and Microbiological Testing
6. Franklin Baker Company of the Philippines- Davao Plant
Address : Coronon, Sta. Cruz, Davao del Sur
Telephone No. : +632 810-2222 Ext. 130
Fax No. : +6382 224-2422 Ext. 180
E-mail : [email protected]
Contact Person : Ms. Hazel Jane F. Joaquin – Quality Assurance Manager
Field of Testing : Chemical Testing and Microbiological Testing
7. Intertek Testing Services Philippines, Inc.
Address : 2307 Chino Roces Avenue Extension Makati City
Telephone No. : 8195841 loc 619
Fax No. : 8195848
E-mail : [email protected]
Contact Person : Chester Lou A. Allones – QMS / Compliance Officer
Field of Testing : Chemical and Microbiological Testing
8. JEFCOR Laboratories, Inc.
Address : Main St., Engineering Building, First Cavite Industrial Estate, Langkaan II, Dasmariñas, Cavite
Telephone No. : (046)402-1318
Fax No. : (046)402-1318
E-mail : [email protected]
Contact Person : Ms. Edna C. Mijares – President and CEO / Ms. Joselette G. Reyes-Blauta – Technical and Marketing Manager
Field of Testing : Chemical Testing
9. Mach Union Water Laboratory, Inc.
Address : Mach Union Bldg., 335 Alabang-Zapote Road, Talon 3, Las Piñas City
Telephone No. : (02) 553-8381,(02) 553-8382, (02) 553-8879
Fax No. : (02) 553-8878
E-mail : [email protected]
Contact Person : Glenn U. Pagulayan – Laboratory manager
Field of Testing : Chemical Testing and Microbiological Testing
10. Optimal Laboratories, Inc. .
Address : Purok I, Balintawak, Lipa 4217 Batangas
Telephone No. : (043) 756-1292, (043) 702-4513, (02) 806-2863
Fax No. : (043)981-3992
E-mail : [email protected]
Contact Person : Ms. Jennifer R. Maralit – General Manager
Field of Testing : Microbiological Testing and Chemical Testing
11. OSTREA Mineral Laboratories, Inc
Address : Bgy. Road, Bo. Mamplasan, Biñan, Laguna
Telephone No. : (632) 8899058
Fax No. : NA
E-mail : [email protected] / [email protected]
Contact Person : Alvin P. Basco – Head of Operations
Field of Testing : Chemical Testing and Microbiological Testing
12. Philippine Institute of Pure and Applied Chemistry (PIPAC)
Address : Ateneo de Manila University
Katipunan Ave., Loyola Heights, Quezon City 1108
Telephone No. : (+632) 8426 6072; (+632) 84266001 loc. 4856, 4857
Fax No. : (+632) 8426 6073
E-mail : [email protected] / [email protected],
Contact Person : Armando Jerome de Jesus, Jr., PhD – Quality Assurance Manager
Field of Testing : Chemical Testing
13. Qualibet Testing Services Corporation
Address : 121 Dangay St., Project 7, Quezon City
Telephone No. : 374-8003/ 372-7993| M: 0917-5593287
Fax No. : NA
E-mail : [email protected] / [email protected]
Contact Person : Joyce Tividad – General Manager
Field of Testing : Chemical Testing and Microbiological Testing
14. Sentro sa Pagsusuri, Pagsasanay at Pangangasiwang Pang-Agham at Teknolohiya Corp. (SENTROTEK Additional Scope of Accreditation for Water)
Address : No. 208 Pilar St., Brgy. Addition Hills, Mandaluyong City, 1550
Telephone No. : (02)8721-6500, (02) 8721-9699 / (02) 8718-3514
Fax No. : (02) 8727-9016
E-mail : [email protected]
Contact Person : Ms. Priscila P. Tongco – Laboratory Manager
Field of Testing : Microbiological Testing and Chemical Testing
15. SGS Philippines, Inc. – Multi-Laboratory
Address : 2229 Alegria bldg., Chino Roces Avenue, Makati City
Telephone No. : (02) 8784-9400
Fax No. : NA
E-mail : [email protected]
[email protected]
[email protected]
Contact Person : Jonalyn T. Samonte – Laboratory Operations Manager / Richardson Billones Jr. – Technical Operations Manager – Chemical Testing / Rosario P. Castillo – Technical Operations Manager – Microbiological Testing
Field of Testing : Microbiological Testing and Chemical Testing
16. XPRT Analytical Services
Address : 3759 Skrene Properties Bldg., Cuenca cor. Emilia Sts.,
Brgy. Palanan, Makati City
Telephone No. : (+632) 8551 3422 loc. 132
Fax No. : (+632) 551 3330
E-mail : [email protected]
Contact Person : Edna L. Liwanag – Laboratory Head
Field of Testing : Chemical Testing
II. Government Laboratories
1. Department of Science and Technology – I
Regional Standards and Testing Laboratory
Address : DMMMSU-MLU Campus, San Fernando City, 2500, La Union
Telephone No. : (072) 242-4878
Fax No. : (072) 242-4878
E-mail : [email protected] / [email protected]
Contact Person : Ms. Lena C. Rosario – Laboratory Head
Field of Testing : Chemical Testing and Microbiological Testing
2. Department of Science and Technology – III Regional Standards and Testing Laboratory
Address : Diosdado Macapagal Gov. Center, Maimpis, City of San Fernando Pampanga 2000
Telephone No. : (045) 455-0800, (045) 455-0554
Fax No. : (045) 455-0800
E-mail : [email protected]
Contact Person : Diana Cecilia Estrella – Technical Manager, Chemistry Laboratory
Field of Testing : Chemical Testing and Microbiological Testing
3. Department of Science and Technology – IVA (CALABARZON) Regional Standards and Testing Laboratory
Address : S & T Complex, Jamboree Road, Timugan, Los Baños Laguna
Telephone No. : (049) 536-4390
Fax No. : (049) 536-4390
E-mail : [email protected], [email protected]
Contact Person : Emelita P. Bagsit – Quality Manager
Field of Testing : Chemical Testing and Microbiological Testing
4. Department of Science and Technology – V Regional Standards and Testing Laboratory
Address : Regional Center Site, Rawis, Legazpi City
Telephone No. : (052) 482-0376; 105 loc. 113
Fax No. : (052) 820-5039
E-mail : [email protected] , [email protected]
Contact Person : Christopher G. Millena – Laboratory Head
Field of Testing : Chemical Testing and Microbiological Testing
5. Department of Science and Technology – VI Regional Standards and Testing Laboratory
Address : Magsaysay Village, La Paz, Iloilo City
Telephone No.: (63 33) 320-0907 / (63 33) 330-1565 Local: 108
Fax No.: (63 33) 320-0908
Email: [email protected] / [email protected]
Contact Person : Ma. Lina B. Gelonga – Laboratory Head
Field of Testing : Chemical Testing / Microbiological Testing
6. Department of Science and Technology – VII Regional Standards and Testing Laboratory
Address : S & T Complex, Sudlon, Lahug, Cebu City
Telephone No. : (032) 254-7051
Fax No. : (032) 254-7049
E-mail : [email protected]
Contact Person : Robert Edra – Laboratory Head
Field of Testing : Chemical Testing and Microbiological Testing
7. Department of Science and Technology – VIII Regional Standards and Testing Laboratory
Address : Government Center, Candahug, Palo, Leyte
Telephone No. : (053) 323-6356
Fax No. : (053) 323-7110
E-mail : [email protected]
Contact Person : Marilyn O. Radam
Field of Testing : Chemical Testing and Microbiological Testing
8. Department of Science and Technology – IX Regional Standards and Testing Laboratory
Address : Pettit Barracks, Zamboanga City
Telephone No. : ( 062) 991-1024
Fax No. : (062) 992-1114
E-mail : [email protected]
Contact Person : Rosemarie Salazar – Laboratory Head
Field of Testing : Chemical Testing and Microbiological Testing
9. Department of Science and Technology – X Regional Standards and Testing Laboratory
Address : Jesus V. Seriña St., Carmen, Cagayan de Oro City
Telephone No. : (088) 858-3931 to 33 loc 26, (088) 850-2653
Fax No. : (088) 858-3931, (088) 850-2653
E-mail : [email protected]
Contact Person : Engr. Romela N. Ratilla, DPA – Quality Manager
Field of Testing : Chemical Testing and Microbiological Testing
10. Department of Science and Technology – XI Regional Standards and Testing Laboratory
Address : DMC Compound, Dumanlas Road, Bajada, Davao City
Telephone No. : (082) 227-5672/ 221-5428
Fax No. : (082) 221-5295
E-mail : [email protected]
Contact Person : Ms. Sheryl N. Napoco – Deputy Quality Assurance Manager
Field of Testing : Chemical Testing and Microbiological Testing
11. Department of Science and Technology – XII (Satellite Laboratory) Regional Standards and Testing Laboratory
Address : Barangay Hall Compound, Calumpang, General Santos City
Telephone No. : (083)554-7997
Fax No. : NA
E-mail : [email protected]
Contact Person : Ms. Samerah B. Macabalang-Datudacula – Technical & Laboratory Manager
Field of Testing : Microbiological Testing
12. Department of Science and Technology – XIII (CARAGA) Regional Standards and Testing Laboratory
Address : CSU Campus, Ampayon, Butuan City
Telephone No. : (085) 342-6225
Fax No. : (085) 342-9053
E-mail : [email protected] / [email protected]
Contact Person : Jennifer Dejarme – Laboratory Head
Field of Testing : Chemical Testing and Microbiological Testing
13. Department of Science and Technology – Cordillera Administrative Region (CAR) Regional Standards and Testing Laboratory
Address : BSU Compd., Km. 6, La Trinidad Benguet 2601
Telephone No. : (074) 422-0979, (074) 422-2214
Fax No. : (074) 422-0979, (074) 422-2214
E-mail : [email protected]
Contact Person : Engr. Angel L. Maguen – Quality Manager
Field of Testing : Chemical Testing and Microbiological Testing
14. Food and Nutrition Research Institute (FNRI) -Service Laboratory
Address : FNRI Building, DOST Compound, Gen. Santos Ave., Bicutan, Taguig, City
Telephone No. : (+632) 8837-8113 loc. 310, (+632) 8512-3077
Fax No. : NA
E-mail : [email protected]
Contact Person : Ms. Rosemarie J. Dumag – Quality Manager / Ms. Joan M. Castro – Chemical Laboratory Technical Manager / Christine Eden C. Sevilla – Microbiological Laboratory Technical Manager
Field of Testing : Chemical Testing and Microbiological Testing
15. Industrial Technology Development Institute (ITDI), Department of Science and Technology Standard Testing Division
Address : Department of Science and Technology Compound, Gen. Santos Avenue, Bicutan, Taguig City
Telephone No. : (632)8837-2071 to 82 loc2198
Fax No. : (632)837-3167
E-mail : [email protected], [email protected]
Contact Person : Rosalinda C. Torres, PhD, RCh, – Quality Manager
Field of Testing : Chemical Testing and Microbiological Testing
16. Philippine Coconut Authority (PCA)
Address : PCA Compound, Eliptical Road, Diliman, Quezon City, 1101
Telephone No. : (632)8928-4501 loc 532
Fax No. : N/A
E-mail : [email protected]
[email protected]
[email protected] (copy furnish)
Contact Person : BENJAMIN R. MADRIGAL, JR. – Administrator Philippine Coconut Authority / MA. CELIA M. RAQUEPO – Division Chief III – Laboratory Services Division
Field of Testing : Chemical Testing and Microbiological Testing
17. Philippine National Collection of Microorganisms (PNCM)
Address : Room 204, National Institute of Molecular Biology and Biotechnology, UPLB, College, Laguna
Telephone No. : 0946-200-1853
Fax No. : none
E-mail : [email protected]
Contact Person : Dr. Rosario G. Monsalud – Scientist I / Fellow, PAM – Laboratory Manager- Technical Manager, Head Curator
and Head Microbiologist / ARMI R. CREENCIA – [email protected] – University Researcher II -Specialist Microbiologist – Quality Manager
Field of Testing : Microbiological Testing

Application for Vaccine and Biological Product Lot Release Certification

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