The Food and Drug Administration, in its commitment to provide stakeholders with streamlined and improved government services, is developing the FDA eServices Portal —online platform for FDA Market Authorization applications.
The FDA wishes to invite stakeholders located within the National Capital Region (Metro Manila) who intend to apply for License to Operate (LTO) as Drug Distributor, Drug Trader, Drugstore, Retail Outlet for Non-Presciption Drugs (RONPD) only, to use the FDA eServices Portal through this link: http://eservices.fda.gov.ph/. The eServices Portal is in its Pilot Implementation, hence the scope of the application is limited for the time being:
FDA eServices Portal Pilot Implementation
|Location of Establishment||National Capital Region (Metro Manila)|
|LTO Establishment Application||Drug Distributor, Drug Trader, Drugstore, Retail Outlet for Non-Prescription Drugs (RONPD)|
|Type of LTO Application||Initial and Variation only|
|Fees to be Paid||Based on Current Issuance on Fees and Charges (Reference: DOH Administrative Order No. 50, s. 2001)|
|Validity of Initial LTO||Current Validity Period Given by FDA – one (1) year|
|Start of Pilot Implementation||07 May 2020|
Applications for Variation in the LTO using the eServices Portal are only functional if the approved initial LTO is applied using the eServices Portal.
For those with existing LTO application via ePortal, you may opt to apply to the eServices Portal for a new fee. Previous payment will be forfeited.
Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, and Annex B of this Advisory for the Step-by-Step Guide in applying in the FDA eServices Portal.
Read more:->FDA Advisory No.2020-781