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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:
Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003
Country/Region:
Philippines
Competent Authority:
Department of Health
Type:
Guideline
Status:
In force
Release Date:
2020-05-18
Implementation Date:
2020-06-02
Applicable Scope:
Aquatic & aquatic products; Alcoholic products; Bakery food; Beverage; Candy products; Condiment; Egg & egg products; Food additive; Food contact materials; Food for special dietary uses; Frozen drinks; Fruits & vegetables; Grain & grain products; Health food; Infant formula food; Meat & meat products; Milk & milk products; Nutrition fortifier; Oil & oil products; Pet food; Others
Document
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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

This guidelines applies to health product. The objectives for issuing this Administrative Order are to simplify the requirements and processes for initial, renewal, and variation of License to Operate (LTO) applications and to re-engineer and streamline the FDA’s processes and automate its system in compliance with the provisions of RA 11032 in the maximum prescribed processing time depending on the complexity of the transaction.

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
2020-05-18
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: 2020-05-18
Implementation Date : 2020-06-02
2016-02-15
Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration
Invalid
Release Date: 2016-02-15
Implementation Date : 2016-03-01