Administrative Order No.2024-0015 Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No.2020-0017

This order prescribes the updated rules, requirements, and procedures for initial, renewal, and variation License to Operate (LTO) application through the FDA sServices Portal System. It also institutionlizes a longer validty period of LTO, as well as the administrative reconsideration mechanism in the regulatory licensing processes.

Content

1. Rationale

2. Objectives

3. Scope

4. Definition of Terms

5. General Guidelines

6. Specific Guidelines

7. Application Requirements

8. Application Procedure

9. Decision of the Application

10. Validity of the LTO

11. Suspension or Cancellation/Revocation of the Issued LTO

12. Transitory Provision

13. Repealing Clause

14. Separability Clause

15. Effectivity