• Drug products
• Medical devices

Non-automatic

• Other

To simplify the requirements and processes for initial, renewal and variation to License to Operate. Inclusion of drug products in the coverage as it has the same procedural guidelines as the medical devices following DOH AO No. 2020-0017.

Same as the "Administrative bodies"

• https://www.fda.gov.ph/wp-content/uploads/2020/05/Administrative-Order-No.2020-0017.pdf

• G/LIC/N/2/PHL/189

• Procedural Guidelines repealing AO No.2016-0003

  
  

• G/LIC/N/2/PHL/189
  
  DOH Administrative Order No.2020-0017 – Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing AO No.2016-0003

  
  

  9033.00.00 - Parts and accessories (not specified or included elsewhere in Chapter 90) for machines, appliances, instruments or apparatus of Chapter 90.

  
  

  Initial, renewal and variation to License to Operate for Traders and Distributors (Wholesalers/Importers/Exporters) of:

  
  

  All medical devices, Radiation-emitting devices, In-vitro diagnostic device and reagents, Refurbished medical devices, Equipment or devices used for treating sharps, Pathological and infectious waste, Water treatment devices/systems, And other health-related devices as determined by the FDA.

  
  

  The said issuance redefined the coverage of activities and establishment regulated by the FDA and repealed AO No. 2016-0003.

  
  

• G/LIC/N/2/PHL/201

  
  

  DOH Administrative Order No. 2020-0017 – Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing AO No. 2016-0003

  
  

  Modification: Other: Inclusion of drug products in the coverage as it has the same procedural guidelines as the medical devices following DOH AO No. 2020-0017.

  
  

  DOH AO No. 2020-0017 was already notified to the WTO for medical devices. Since the procedural guidelines for drug products and medical devices are similar, there is a need to update the N2 Notification for DOH AO No. 2020-0017 to include drug products as follows:

  
  

  Drugs

  
  

  HS 30 Pharmaceutical products

  
  

  Initial, renewal and variation to License to Operate applications of Manufacturers (including packers/repackers), Traders, Distributors (as importers, exporters, and/or wholesalers), drug outlets such as drugstores, pharmacies (community, hospital or institutional) or boticas, and retail outlets for non-prescription drugs (RONPDs) of all drugs including vaccines, biologics, veterinary medicines, and animal health products, medical gases, traditional medicine, and herbal medicine.