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

With the issuance of the Guidelines, the Philippines Food and Drug Administration (FDA) aims to simplify the requirements and processes for the initial, renewal, and variation applications of the License to Operate (LTO), re-engineer and streamline FDA’s processes, and automate its system in compliance with the provisions of RA 11032 on the maximum prescribed processing time depending on the complexity of the transaction.

Table of 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