Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003

This guidelines applies to health product. The objectives for issuing this Administrative Order are to simplify the requirements and processes for initial, renewal, and variation of License to Operate (LTO) applications and to re-engineer and streamline the FDA’s processes and automate its system in compliance with the provisions of RA 11032 in the maximum prescribed processing time depending on the complexity of the transaction.

Content

1. Rationale

2. Objectives

3. Scope and Coverage

4. Definition of Terms

5. General Guidelines

6. Specific Guidelines

7. Penalty Clause

8. Repealing Clause

9. Separability Clause

10. Effectivity