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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
Local Title:
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
Country/Region:
Philippines
Competent Authority:
Department of Health
Type:
Regulation
Status:
To be enforced
Release Date:
2024-11-27
Implementation Date:
2024-12-12
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
Language Source Title Access
EN
 Official 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
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EN
 Official Annex A Definition of Terms
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EN
 Official Annex B Requirements for Initial, Renewal, Variation LTO Application
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EN
 Official Annex C Qualified Person Qualifications and Credential Requirements
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EN
 Official Annex D List of Requirements for Specific Variation in the LTO
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EN
 Official Annex E LTO Applications Exempted from Automatic Renewal
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EN
 Official Annex F FDA Application Payment Procedure Through the eServices Portal System
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EN
 Official Annex G Rules on Renewal Application Fees and Surcharges
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EN
 Official Annex H LTO Process Flow
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Summary

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

History
2024-11-27
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
To be enforced
Release Date: 2024-11-27
Implementation Date : 2024-12-12
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
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