FDA mandates electronic filing for License to Operate
Export Development Council News
October 18, 2016

 Started September 1, 2016, the Food and Drug Administration (FDA) mandates all applicants for License to Operate (LTO) to file their applications through the FDA website (www.fda.gov.ph).

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).□