Philippines: Facilitated pathway for Household/Urban Hazardous Substances (HUHS)

 

Philippines has adopted a Phased Implementation Framework for the Facilitated Registration Pathway of Household/Urban Hazardous Substances (HUHS) Products.

The proposed issuance aims to provide further regulatory flexibilities for Household/Urban Hazardous Substances (HUHS) product registration, particularly establishing a phased implementation framework for the facilitated registration pathway.

Republic Act (RA) No. 3720, as amended by RA No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009”, mandates the FDA to ensure health products, including Household/Urban Hazardous Substances (HUHS), are safe, effective, and of good quality. In line with this mandate, the Department of Health (DOH) Administrative Order (AO) No. 2019-0019, entitled “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products” was issued to realign the regulatory framework with the FDA’s mandate, repealing AO No. 2015-0038.

Meanwhile, RA No. 11032, otherwise known as the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018,” directs the FDA to streamline the regulatory systems and procedures in the issuance of authorizations. Accordingly, the introduction of a facilitated registration pathway for HUHS products is envisioned to improve efficiency and enhance service delivery. Therefore, to ensure policies remain adaptive and responsive while facilitating gradual compliance with new requirements and guidelines, this Order hereby adopts a phased implementation framework for the facilitated registration pathway for the HUHS product.

Other relevant regulations for this topic are:

• Republic Act (RA) No. 9711 and its Implementing Rules and Regulations (IRR): The Food and Drug Administration (FDA) Act of 2009
• DOH AO 2019-0019: Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products
• FDA Circular 2020-025: Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products
• FDA Circular No.2021-011-A: Extension of Transitory Period and Provision of Interim Guidelines for Product Registration, including the Labeling Requirements, for Household Urban/Hazardous Substances

To find out more about product compliance for chemical products, do not hesitate to contact the Product Compliance Institute directly.