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Downloadables

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.

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

Post-Approval Changes (PACs)

Guidance Documents


ASEAN Common Technical Dossier (ACTD)

Part I

Part II

Part III

Part IV

 ASEAN Common Technical Requirements(ACTR)

 Analytical Validation

Bioavailability & Bioequivalence Study

Provisitional List

Process Validation

Stability

Variation

Center for Food Regulation and Research

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

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:

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

Common Services Laboratory

LIST OF ACCREDITED LABORATORIES 2020

  I. PRIVATE LABORATORIES
    1. Center of Excellence in Drug and Research, Evaluation and Studies, Inc. (CEDRES)
 Address:  4/F BMD Building, RITM Compound, Filinvest

Corporate City, Alabang, Muntinlupa City

 Telephone No.:  8785-6379
 Fax No.:  N/A
 Email:  [email protected]
 Contact Person:  Salvador de Guzman Jr. 
Laboratory Manager
 Field of Testing:  Chemical Testing
    2. F.A.S.T Laboratories Services and Technical Cooperative_Calamba
 Address:  Allied Concrete Building, Km. 54. Bgy. Makiling, Calamba City, Laguna
 Telephone No.:  (02)584-4577; (049)-508-7138; 0917-562-6339+C29C20:C28
 Fax No.:  635-6773
 Email:   [email protected]; This email address is being protected from spambots. You need JavaScript enabled to view it.;">[email protected];    [email protected]
 Contact Person:  Ms. Yehlen Ma. Salilid
Quality Assurance Manager
Dennis P. Sibongga
 Laboratory Business manager
 Field of Testing:  Chemical Testing and Microbiological Testing
    3. 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
 Email:  [email protected]
 Contact Person:  Ms. Lovebeth S. Mendoza- Laboratory Manager
Yehlen Salilid- Quality Assurance Manager
 Field of Testing:  Chemical Testing and Microbiological Testing
    4. 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
 Email:  [email protected]
 Contact Person:  Patricia B. Parales
Laboratory Manager
 Field of Testing:  Chemical Testing and Microbiological Testing
    5. Franklin Baker Company of the Philippines- Davao Plant
 Address:  Coronon, Sta. Cruz, Davao del Sur
 Telephone No.:  82 286-2508
 Fax No.:  82 224-2422
 Email:  [email protected]
 Contact Person:  Ms. Hazel Jane F. Joaquin
Quality Assurance Manager
 Field of Testing:  Microbiological Testing
    6. GCH Center for Food Safety and Quality, Inc.
 Address:  2F Tres Borces St., Brgy. Mabolo, Cebu City, 6000 Philippines
 Telephone No.:  (32) 412-1229 (032) 232-1929
 Fax No.:  (32) 231-0103
 Email:  [email protected]
 Contact Person:  Catherine Rose G. Aliganga - Laboratory Head
 Quennelyn M. Gaviola - Laboratory Supervisor
 Field of Testing:  Microbiological Testing
    7. Intertek Testing Services Philippines, Inc.
 Address:  2307 Chino Roces Avenue Extension Makati City
 Telephone No.:  8195841 loc 619
 Fax No.:  8195848
 Email:  [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
 Email:  [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
 Email:  [email protected]
 Contact Person:  Glenn U. Pagulayan
 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
 Email:  [email protected]
 Contact Person:  Ms. Jennifer R. Maralit
General Manager
 Field of Testing:  Chemical Testing and Microbiological Testing
    11. OSTREA  Mineral Laboratories, Inc.
 Address:  Bgy. Road, Bo. Mamplasan, Biñan, Laguna
 Telephone No.:  (632) 8899058
 Fax No.:  N/A
 Email:  [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)
 Email:  [email protected]
[email protected],
 Contact Person:  Armando Jerome de Jesus, Jr., PhD
Quality Assurance Managerr
 Field of Testing:  Chemical Testing
    13. Qualibet Testing Services Corporation
 Address:  121Dangay St., Project 7, Quezon City
 Telephone No.:  374-8003/  372-7993| M: 0917-5593287
 Fax No.:  N/A
 Email: [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
Email:  [email protected]
Contact Person:  Ms. Priscila P. Tongco
Laboratory Manager
 Field of Testing:  Chemical Testing and Microbiological Testing
    15. SGS Philippines, Inc. - Multi-Laboratory
 Address:  2229 Alegria bldg., Chino Roces Avenue, Makati City
 Telephone No.:  (02) 8784-9400
 Fax No.:  N/A
 Email:  [email protected] / [email protected] /   [email protected]
 Contact Person:  Neriza N. Ramos
Laboratory Operations Manager
Jonalyn T. Samonte
Technical Operations Manager – Chemical Testing
 Rosario P. Castillo
Technical Operations Manager – Microbiological Testing
 Field of Testing:  Chemical Testing and Microbiological Testing
    16. XPRT Analytical Sevices
 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
 Email:  [email protected]
 Contact Person:  Edna L. Liwanag
Laboratory Head
 Field of Testing:  Chemical Tesing
   II. Government Laboratories
    1. Department of Science and Technology – I Regional Standards and Testing Laboroatory
 Address:  DMMMSU-MLU Campus, San Fernando City, 2500, La Union
 Telephone No.:  (072) 242-4878
 Fax No.:  (072) 242-4878
 Email:  [email protected]
 Contact Person:  Anita A. Criste
Laboratory Head
 Field of Testing:  Chemical Testing and Microbiological Testing
    2. Department of Science and Technology – III Regional Standards and Testing Laboroatory
 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
 Email:  [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 Laboroatory
 Address:  S & T Complex, Jamboree Road, Timugan, Los Baños Laguna
 Telephone No.:  (049) 536-4390
 Fax No.:  (049) 536-4390
 Email:  [email protected],  [email protected]
 Contact Person:  Emelita P. Bagsit
Quality Manager
 Field of Testing:  Chemical Testing Microbiological Testing
    4. Department of Science and Technology – V Regional Standards and Testing Laboroatory
 Address:  Regional Center Site, Rawis, Legazpi City
 Telephone No.:  (052) 482-0376; 105 loc. 113
 Fax No.:  (052) 820-5039
 Email:  [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 Laboroatory
 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 and Microbiological Testing
   6. Department of Science and Technology – VII Regional Standards and Testing Laboroatory
 Address:  S & T Complex, Sudlon, Lahug, Cebu City
 Telephone No.:  (032) 254-7051
 Fax No.:  (032) 254-7049
 Email:  [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 Laboroatory
 Address:  Government Center, Candahug, Palo, Leyte
 Telephone No.:  (053) 323-6356
 Fax No.:  (053) 323-7110
 Email:  [email protected]
 Contact Person:  Marilyn O. Radam
 Field of Testing:  Chemical Testing
    8. Department of Science and Technology – IX  Regional Standards and Testing Laboroatory
 Address:  Pettit Barracks, Zamboanga City
 Telephone No.:  (062) 991-1024
 Fax No.:  (062) 992-1114
 Email:  [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 Laboroatory
 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
 Email:  [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 Laboroatory
 Address:  DMC Compound, Dumanlas Road, Bajada, Davao City
 Telephone No.:  (082) 227-5672/ 221-5428
 Fax No.:  (082) 221-5295
 Email:  [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 Laboroatory
 Address:  Barangay Hall Compound, Calumpang, General Santos City
 Telephone No.:  (083)554-7997 ; 0997-632-5459
 Fax No.:  N/A
 Email:  [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 Laboroatory
 Address:  CSU Campus, Ampayon, Butuan City
 Telephone No.:  (085) 342-6225
 Fax No.:  (085) 342-9053
 Email:  [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
 Email:   [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.:  N/A
 Email: [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
  Email:  [email protected][email protected]
 Contact Person:  Rosalinda C. Torres, PhD, RCh
Quality Manager
 Field of Testing:  Chemical Testing and Microbiological Testing