Regulatory Services for Chemical Products & Mixtures in the Philippines

Overview

Here are a few key facts for you!

  • Household/Urban Hazardous Substances (HUHS) products are divided into five (05) categories, and Surface disinfectants/Detergents-cleaners fall under Category III.
  • The products in Category III can be classified as ready-to-use products and professional use (highly concentrated) products.
  • HUHS products cover a large variety of products range (mentioned in Annex A of the FDA circular 2020-025) except pharma, cosmetics, and medical devices.

General Requirements for HUHS Products (Surface Disinfectant/Detergent-Cleaners)

  • Shall be classified into the relevant category
  • Shall not contain CMR ingredient or banned ingredient
  • Shall not bear unsubstantiated claims or misleading information
  • HUHS manufacturers should follow good manufacturing practice
  • Product Information File (PIF) shall be maintained and kept ready post-registration for inspection purposes

Expertise

Freyr Expertise

  • Company Product Registration (CPR) services
    • Product classification
    • Building data requirements matrix
    • Data collection and data gaps validation
    • Preparation of declaration statements & application form
    • Application submission via FDA e-portal
    • Post-submission support - Quick responses to authority raised queries before the assigned deadlines
    • Follow up till approval and approval validation
  • License To Operate (LTO) application submission
  • LTO holder legal representative & authorized holder services
  • Regulatory intelligence support
Freyr Advantages
Advantages

Freyr Advantages

  • End-to-end chemical Regulatory services
  • Expert advice on the Regulatory strategy
  • Easily navigate complexities of Regulatory authorities
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance
  • Robust partner network in the Philippines
  • Focused regulatory compliance solution
  • Quick turnarounds and faster time-to-market