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Guidelines on the Unified Licensing Requirements and Procedures of the FDA

Local Title
/
Country/Region
Philippines
Competent Authority
Philippines Food and Drug Administration
Type
Regulation
Status
In force
Release Date
2016-02-15
Implementation Date
2016-03-01
Expert Translation AI Translation View Official Documents

This Order sets the guidelines on a unified, harmonized and streamlined licensing requirements of the Food and Drug Administration to hasten its approval process and strengthen its post-marketing surveillance activities.

Table of Content:

  1. Rationale

  2. Objectives

  3. Scope

  4. General Guidelines

  5. Specific Guidelines

  6. Procedure

  7. Penalty Clause

  8. Repealing Clause

  9. Separability Clause

  10. Mandatory Review

  11. Effectivity

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