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
