Citizen Charter – License to Operate

Drug Establishments Manufacturer

• Initial
• Renewal
• Variation
  • Major Variation

Manufacturers of Household Urban Hazardous Substances (HUHS)

• Initial
• Renewal
• Variation
  • Major Variation

Traders, Distributors (Importer, Exporter, Wholesaler) under the Center of Drug Regulation and Research (CDRR)

• Initial
  • Drugs, Drugstores/Retail Outlets for Non-Prescription Drugs (RONPD), Sponsors and Clinical Research Organization (CRO)
• Renewal
  • Drugs, Drugstores/Retail Outlets for Non-Prescription Drugs (RONPD), Sponsors and Clinical Research Organization (CRO)
• Variation
  • Minor Variation
    • Drugs, Drugstores/Retail Outlets for Non-Prescription Drugs (RONPD), Sponsors and Clinical Research Organization (CRO)

Food and Drug Action Center

• Issuance of Electronic Portal (E-Portal) User Account
• Issuance of Appointment Schedule and Document Tracking Number (for DOH One-stop Shop only)
• Receiving of Application(s) and Other Documents of FDAC – Public Assistance and Complaint Desk (PACD) (for CAPA submission)

Food Establishments Manufacturer

• Initial
• Renewal
• Variation
  • Major Variation

Traders, Distributors (Importer, Exporter, Wholesaler) of Household Urban Hazardous Substances (HUHS)

• Initial
• Renewal
• Variation
  • Minor Variation

Traders, Distributors (Importer, Exporter, Wholesaler, Retailer) under the Center for Food Regulation and Research (CFRR)

• Initial
• Renewal
• Variation
  • Minor Variation

Cashier

• Issuance of Official Receipt
• Posting of Payment

Medical Device Establishments Manufacturer

• Initial
• Renewal
• Variation
  • Major Variation

Traders, Distributors (Importer, Exporter, Wholesaler, Retailer) under the Center for Device Regulation, Radiation Health, and Research (CDRRHR)

• Initial
• Renewal
• Variation
  • Minor Variation

Regional Field Office

Issuance of Certificate of Compliance (COC), Recommendation Letter (RL) for Disapproval (RFD) and Recommendation Letter (RL)

Establishments Manufacturer under the Center for Cosmetics and Household Urban/Hazardous Substances Regulation and Research (CCHUHSRR)

• Initial
  • Cosmetics, Toys and Childcare Articles (TCCAs), Household Urban Pesticides (HUPs)

• Renewal
  • Cosmetics, Toys and Childcare Articles (TCCAs), Household Urban Pesticides (HUPs)

• Variation
  • Major Variation

Traders, Distributors (Importer, Exporter, Wholesaler, Retailer) under the Center for Cosmetics and Household Urban/Hazardous Substances Regulation and Research (CCHUHSRR)

• Initial
  • Cosmetics, Toys and Childcare Articles (TCCAs), Household Urban Pesticides (HUPs)

• Renewal
  • Cosmetics, Toys and Childcare Articles (TCCAs), Household Urban Pesticides (HUPs)

• Variation
  • Minor Variation
    • Cosmetics, Toys and Childcare Articles (TCCAs), Household Urban Pesticides (HUPs)

Household Urban Pest Control Operators under the Center for Cosmetics and Household Urban/Hazardous Substances Regulation and Research (CCHUHSRR)

• Initial

Field Regulatory Operations Office Inspection Agenda

A.     SIMPLE

• Bureau of Customs – For Donation and For Personal Use
• Inspection Agenda for Health Products held at the Bureau of Customs/Consignee’s warehouse for verification and final disposition

B.     COMPLEX

• Inspection Agenda – Food Distributor
• Inspection Agenda – Food Trader
• GDP Food Inspection Agenda
• Inspection Agenda – Drug & Medical Device Distributor
• Inspection Agenda – Drugstore
• Inspection Agenda – Retail Outlet for Non-Prescription Drugs (RONPD)
• Inspection Agenda – Cosmetics & Household Urban Pesticides Distributor
• Inspection Agenda – Hospital Pharmacy

C.     HIGHLY TECHNICAL

• Inspection Agenda – Food Manufacturer/ Repacker/ Bottled Water Manufacturer
• Inspection Agenda- Vaccine and/or Biologicals
• Inspection Agenda – Stem Cell
• Inspection Agenda – Traditional Medicines
• Inspection Agenda – Drug Trader
• Inspection Agenda – Drug, Medical Device and Cosmetic Repacker/ Packer
• Inspection Agenda – External Household Remedy/External OTC
• Inspection Agenda – Medicinal Gas
• Inspection Agenda – Sterile and Medical Device Manufacturers
• Inspection Agenda – Non-Sterile and Medical Device Manufacturers
• Inspection Agenda – Radiopharmaceuticals
• Inspection Agenda – Toys and Childcare Articles Manufacturer
• Inspection Agenda – Cosmetics & Household Urban Pesticides Distributor
• Inspection Of Manufacturer/Repacker – Cosmetics/Household Urban Pesticides /Toys and Child Care Articles (TCCAs)