Information document:
How to apply for e-portal
Documentary requirements for the application are provided under FDA Administrative Order
(AO) No. 2016-0003 (Guidelines on the Unified Licensing Requirements and Procedures of the
FDA). They must be submitted in PDF file format through the FDA e-portal.
Filing applications through the e-portal requires an authorized user account to be provided via
email by the Public Assistance, Information and Receiving (PAIR) unit of FDA.
This new system facilitates applications nationwide especially in the regions. For more details,
please click FDA Circular No. 2016-004 (Procedure on the Use of the New Application Form
for License to Operate thru the Food and Drug Administration (FDA) Electronic Portal (e-portal))
and FDA Circular NO. 2016-006 (New Format of License to Operate (LTO) for Establishments
Regulated by the FDA).□
FDA Administrative Order (AO) No. 2016-0003
III.
This Order shall apply to the four (4) FDA Centers - namely, Center for Cosmetics
Regulation and Research (CCRR), Cents for Drug Regulation and Research (CDRR),
Center for. Food Regulation and Research (CFRR), Center for Device Regulation,
Radiation Health and Research (CDRRHR) - and the field Regulation Operations Office
(FROO).
IV.
B. All establishments covered in this AO shall first secure the appropriate LTO or authorization
from FDA prior to engaging in the manufacture, importation exportation, sale, offering for sale,
distribution, transfer., promotion, advertisement and/or sponsorship of any activity that involves
health product.
E. All covered establishments shall be under the supervision of a qualified person(s) as required
by pertinent rules and regulations (refer to Annex A).
F. The FDA shall have the authority to enter any covered establishment for (l) inspection and/or
(2) verification of documents submitted to FDA in support of its application for license.
V.
A. In case the health product has been banned or withdrawn for health and safety reasons in the
country of origin, the importer shall immediately undertake the necessary measures in banning from
the public its sale, distribution or donation, or its immediate recall, withdrawal or seizure from the
market.
D.
PROCEDURE
A. Application Requirements: The following are the requirements for application of a License to Operate
(LTO).
1. Initial Application
(a) Accomplished Application Form and Declaration and Undertaking
(b) Proof of Business Name Registration
(c) Site Master File (for manufacturers of drugs, devices and cosmetics) |
(d) Task Management Plan
(e) Payment
2. Renewal Application
(a) Accomplished Application Form with Declaration and Undertaking
(b) Payment Guidance for the above requirements is attached as Annex "A".
E. Cancellation of License to Operate l. Automatic. Existing establishments that fail to file an application
for renewal after one-hundred twenty (120) days from the date of expiration shall be automatically
cancelled and deleted from the list of licensed establishments without prejudice to their re-application.
In case the business address of the applicant is different from the one indicated in its business name
registration, the applicant must submit a copy of its valid Business Permit.
