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Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003
Local Title:
/
Country/Region:
Philippines
Competent Authority:
Philippines Food and Drug Administration
Type:
Regulation
Status:
In force
Release Date:
2020-05-08
Implementation Date:
2020-05-23
Document
Language Source Title Access
EN
 Official Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003
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Summary

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

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
User Guide