Republic Act (RA) No. 9711 otherwise known as the “Food and Drug Administration Act of 2009” is promulgated to enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and health products under its jurisdiction. Further, Book 1 Article IV.f.1. of RA No. 9711 provides that the FDA, through its Information Communication and Technology Management Division (ICTMD), shall develop and manage the management information systems and information technology infrastructures including telecommunications services, and information resources, among others.
On 29 September 2020, the FDA Verification Portal was launched wherein a comprehensive list of FDA licensed establishments and registered and notified health products is available for the general public. This enables the stakeholders such as the consumers, government agencies, and other interested groups to access and validate the health products available in the market for consumption and use.
In view of the above and for the continuous delivery of FDA services and information dissemination, this Advisory is hence issued to inform all stakeholders of the information published and available in the FDA Verification Portal.
I. Accessibility and Available Information
A. The FDA Verification Portal is accessible at https://verification.fda.gov.ph to all stakeholders and general public.
B. The Portal shall provide the following list of information for public reference:
1. Licensed Establishment for Drug, Food, Medical Device, Health Related Device, X-ray Facility, Cosmetic, Household/Urban Hazardous Substances, Toys and Childcare Articles Household/Urban Pesticides and Pest Control Operators;
2. Registered Health Products such as Food, Drugs, Biologicals, Vaccines, In-Vitro Diagnostic Reagents, Household/Urban, Hazardous Substances, Medical Devices, Health-Related Device such as Water Purification System or Device and Equipment or Device used for Treating Sharps, Pathological and Infectious Wastes
3. Certificate of Compliance for Radiation Facilities Under One Stop Shop;
4. Notified Medical Device, Cosmetic Products, Toys and Childcare Articles;
5. Batch Notification;
6. Lot Release Certificate;
7. VAT-Exempt Health Products in accordance with RA No. 11534 otherwise known as the “Corporate Recovery and Tax Incentives for Enterprises Act”;
8. Summary of Product Characteristics (SPC) / SPC-like and Patient Information Leaflet (PIL);
9. Notified Imported Drug Products and Raw Materials;
10. Accredited Bioavailability (BA)/ Bioequivalence (BE) Facilities;
11. Approved Clinical Trials;
12. Certified local and foreign manufacturers with Good Manufacturing Practices (CGMP); and
13. Sales Promo Permit.
C. The comprehensive lists pertained in item I.A. can be selected in the navigation pane for viewing. The Portal shall generate the selected list which can be exported to Microsoft Excel spreadsheet, Microsoft Word, CSV format, or PDF format.
D. The FDA Verification Portal is illustrated in the Annex B of this Advisory.
The information in the Verification Portal is published with the purpose of disseminating regulatory information free of charge for the benefit of the public. The information provided in the Verification Portal shall only be used for purposes of verification and shall in no case be used for any unlawful purpose. The information posted is up-to-date in accordance with the schedule adopted in this advisory. A matrix containing the information posted on the Portal is reflected in Annex A.
The information provided in the Verification Portal is not, however, considered as regulatory advice. It is not a substitute for any certifications that may be issued by the FDA for lawful purposes. Hence, the Food and Drug Administration does not accept any liability for any injury, loss or damage incurred by use of or reliance on the information provided on this website.
III. Corrections and Contact Information
A. In the event that the portal has inconsistent entries, stakeholders may submit a correction using the “Verification Portal Request Form” accessible through the “Correction/Addition Request” icon located at the navigation bar (refer to Annex B). Upon submission of the Verification Portal Request Form, the request shall be subsequently endorsed to the concerned FDA Office for verification. The said form is provided in Annex C of this Advisory.
B. Information in Section I.A. shall be published in the FDA Verification Portal within three (3) working days upon receipt of request of the ICTMD. Provided in Annex D is the frequency of posting per document category.
For inquiries regarding this Advisory, kindly contact the FDA through email at [email protected], indicating the Advisory No. and Title in the email subject line.
For the information of everyone.