Monday, March 4, 2013

Renewal and Change of Circumstances of S-License for Drug Establisment

Application Sheet should be attached on the first page. Green folder should be used in submission of requirements. The following are requirements:

  1. NBI Clearance (Authorized Pharmacist)
  2. PRC ID Card (Authorized Pharmacist)
  3. PTR (Authorized Pharmacist)
  4. DTI/ SEC/ CDA Certificate
  5. General Information Sheet – GIS (corporations only)
  6. Business/Mayor’s Permit
  7. FDA or DOH - CHD LTO Certificate with official receipt
  8. BOC Accreditation Certificate(importer/exporter only)
  9. *Projection for forthcoming year (importer/ manufacturer only)
  10. Certificate of Product Registration – CPR (importer/ manufacturer/ exporter only)
  11. Latest Semi-Annual Report Submitted
  12. *Record Book / Register with updated recording
  13. *Latest S – license issued (to be surrendered)

    FOR MATERIAL CHANGES - Submit the following:

    a) Head or authorized pharmacist
    - TIN
    - NBI
    - Current Organizational structure, certified correct by Human Resource (HR) Officer of company with pictures of officers 
    b) Business address
    - Location/Vicinity Map
    - Floor plan/ Layout to highlight controlled drug storage area
    - Picture of Drug Establishment (fa├žade)
    - Picture of controlled drug storage area
    - Proof of ownership/ Lease of Contract

    *Original current document required. For the rest of the requirements, submit clear photocopy and present original for validation.