ASEAN-Philippines Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration

This Administrative Order repeals AO 2020-0017 and governs the procedures for initial, variation and renewal applications of License to Operate (LTO) for health product establishments via the FDA eServices Portal. It adopts risk-based regulation, extends LTO validity and establishes an administrative reconsideration mechanism. It applies to cosmetic, pharmaceutical, medical device and other health product manufacturers, importers and distributors, requiring establishments to comply with applicable standards such as GMP.