The Food and Drug Administration (FDA), in its commitment to provide stakeholders with streamlined and improved government services, has issued FDA Circular No. 2020-030 on 16 October 2020 as implementing guideline in the application for License to Operate (LTO) of Drug Non-Manufacturing Establishments in the eServices Portal System.
Starting 26 October 2020, the FDA shall now accept LTO application (Initial, Renewal, and Variation) of the following Drug Establishments nationwide:
- Drug Distributor
- Drug Trader
- Drugstore
- Retail Outlet for Non-Prescription Drug (RONPD)
- Clinical Research Organization (CRO)
- Sponsor
The eServices Portal System is accessible through this website: eservices.fda.gov.ph
The ePortal System shall remain online for Drug Establishments with on-going/in-process LTO applications and Drug Manufacturer LTO applications.
For information and guidance.
Attachment:-> Full Implementation of eServices Portal System for License to Operate (LTO)