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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
Document
Language Source Title Access
EN
 Official administrative_order_no._2016-0003.pdf
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Guidelines on the Unified Licensing Requirements and Procedures of the FDA
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Summary

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

History
2020-05-08
Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003
In force
Release Date: 2020-05-08
Implementation Date : 2020-05-23
2016-02-15
Guidelines on the Unified Licensing Requirements and Procedures of the FDA
In force
Release Date: 2016-02-15
Implementation Date : 2016-03-01
Noteworthy Information
User Guide