Pharmaceutical and commercial licenses

First: Requirements for Preliminary Approval
This stage aims to verify the investor's eligibility and the site’s suitability before starting construction or renovation works.
  • Legal Documents:
    • Commercial Registration: The facility’s commercial registration must be valid and include the activity "Pharmacy" or "Drug Warehouse".
    • Title Deed or Lease: Provide a copy of the title deed or lease for the site, with a lease term of at least 5 years.
  • Location and Plans:
    • Location: The site must be on a commercial street, and the distance between this pharmacy and any other pharmacy should be at least 50 meters in major cities, and 100 meters in smaller cities or villages.
    • Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing for the site.
    • Preliminary Architectural Plans: Submit preliminary architectural plans for the pharmacy, approved by an engineering office. The plans should show:
      • Sales area and display of pharmaceutical products.
      • Storage room.
      • Drug preparation area (if available).
Second: Requirements for Final Operating License
After obtaining preliminary approval and completing construction and setup, the process moves to this stage to obtain the final operating license.
  • Engineering and Technical Requirements:
    • Building License: Provide a copy of the building license issued by the Ministry of Municipal and Rural Affairs and Housing.
    • Civil Defense Approval: Obtain approval from the General Directorate of Civil Defense.
    • Interior Design: The pharmacy should have a spacious design suitable for serving customers, with appropriate shelves and lighting.
    • Cooling System: The pharmacy must have an efficient air conditioning system to prevent medication spoilage, with refrigerators for medications that require cooling.
  • Specialized Staff:
    • Responsible Pharmacist: The technical manager or responsible pharmacist must be Saudi and hold a valid professional classification from the Saudi Commission for Health Specialties.
    • Pharmacy Assistants: Pharmacy assistants may be employed but must hold valid professional classifications.
    • Staffing Ratio: Comply with the minimum required staff, which is at least one pharmacist.
  • Equipment and Facilities:
    • Medications and Products: All medications and products in the pharmacy must be registered and licensed by the Saudi Food and Drug Authority (SFDA).
    • Electronic System: The pharmacy must have an electronic system to manage sales and inventory, linked to relevant government platforms.
    • Equipment: Provide necessary tools and equipment, such as blood pressure monitors, glucose meters (if available), and drug preparation tools.
  • Additional Requirements:
    • Insurance: Obtain professional liability insurance.
    • Compliance: The pharmacy must comply with all regulations and laws of the Ministry of Health and the Saudi Food and Drug Authority, especially regarding the sale of controlled medications.
First: Requirements for Initial Approval
This stage aims to verify the investor’s eligibility and the suitability of the site before starting construction or renovation work.
  • Legal Documents:
    • Commercial Register: The establishment’s commercial register must be valid and include the activity “Sale of Herbal Preparations” or “Trade of Herbal Preparations.”
    • Title Deed or Lease Contract: Provide a copy of the title deed or lease contract for the site.
  • Site and Plans:
    • Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing for the site.
    • Preliminary Engineering Plans: Submit preliminary engineering plans for the facility, approved by an engineering office. The plans must show:
      • Product display area.
      • Storage area.
      • Reception area.
Second: Requirements for Final Operating License
After obtaining the initial approval and completing construction and preparation work, this stage is undertaken to obtain the final license.
  • Engineering and Technical Requirements:
    • Building Permit: Provide a copy of the building permit issued by the Ministry of Municipal and Rural Affairs and Housing.
    • Civil Defense Approval: Obtain approval from the General Directorate of Civil Defense.
    • Interior Design: The facility’s design must be spacious and suitable for displaying products, with adequate lighting and ventilation.
    • Storage System: The facility must be equipped with a suitable storage system to ensure the quality and safety of herbal preparations.
  • Specialized Staff:
    • Technical Supervisor: The facility must have a qualified technical supervisor with an academic degree in pharmacy, nutrition, or any related field, and a professional classification from the Saudi Commission for Health Specialties (if the specialty falls under its scope).
  • Equipment and Facilities:
    • Products: All herbal preparations offered for sale must be licensed by the Saudi Food and Drug Authority.
    • Electronic System: The facility must have an electronic system for managing sales and inventory.
  • Additional Requirements:
    • Insurance Document: Obtain professional liability insurance (if required by regulations).
    • Regulatory Compliance: The facility must comply with all regulations and rules of the Food and Drug Authority, especially regarding product safety and medical claims.
First: Requirements for Preliminary Approval
This stage aims to verify the investor’s eligibility and the site’s suitability before starting construction or renovation works.
  • Legal Documents:
    • Commercial Registration: The commercial registration of the facility must be valid and include the activity "Dental Laboratory and Prosthetics".
    • Ownership Deed or Lease Contract: Submit a copy of the ownership deed or lease contract for the location.
  • Location and Plans:
    • Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing for the site.
    • Preliminary Engineering Plans: Submit preliminary engineering plans for the laboratory, certified by an engineering office. The plans should show:
      • Work sections (e.g., Casting section, Wax section, Ceramic section).
      • Storage room.
      • Sterilization area.
      • Ventilation system.
Second: Requirements for Final Operating License
After obtaining preliminary approval and completing construction and equipment setup, the facility can proceed to this stage to obtain the final license.
  • Engineering and Technical Requirements:
    • Building Permit: Submit a copy of the building permit issued by the Ministry of Municipal and Rural Affairs and Housing.
    • Civil Defense Approval: Obtain approval from the General Directorate of Civil Defense.
    • Ventilation System: The laboratory must have an effective ventilation system to remove fumes and harmful chemicals.
    • Infection Control System: Implement a strict and comprehensive system for sterilization and disposal of medical waste according to standards.
  • Specialized Staff:
    • Technical Director: The laboratory’s technical director must be a Saudi dental technician with a valid professional classification from the Saudi Commission for Health Specialties.
    • Technicians: All technicians must hold a valid professional classification from the Saudi Commission for Health Specialties.
  • Equipment and Facilities:
    • Technical Equipment: Provide all necessary equipment and tools for manufacturing prosthetics, such as casting furnaces, wax devices, casting machines, and 3D printing devices (if available).
    • Raw Materials: All raw materials used (e.g., ceramics, acrylics, metals) must be registered and licensed by the Saudi Food and Drug Authority.
    • Documentation System: Provide an electronic or paper system to document all work and requests from clinics.
  • Additional Requirements:
    • Insurance Policy: Obtain an insurance policy against professional errors.
    • Compliance with Regulations: The laboratory must comply with all regulations and systems of the Saudi Food and Drug Authority, particularly regarding product safety.
    • Accreditation: Obtain accreditation from the Saudi Center for Accreditation of Healthcare Institutions (CBAHI), which is mandatory for operation.
First: Requirements for Preliminary Approval
This stage aims to verify the investor’s eligibility and the site’s suitability before starting the setup works.
  • Legal Documents:
    • Commercial Registration: The commercial registration of the facility must be valid and include the activity "Optical Store" or "Retail of Optical Products".
    • Ownership Deed or Lease Contract: Submit a copy of the ownership deed or lease contract for the location.
  • Location and Plans:
    • Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing for the site.
    • Preliminary Engineering Plans: Submit preliminary engineering plans for the store, certified by an engineering office. The plans should show:
      • Display area for eyeglasses.
      • Eye examination room.
      • Assembly workshop.
      • Customer waiting area.
Second: Requirements for Final Operating License
After obtaining preliminary approval and completing the setup works, the facility can proceed to this stage to obtain the final license.
  • Engineering and Technical Requirements:
    • Building Permit: Submit a copy of the building permit issued by the Ministry of Municipal and Rural Affairs and Housing.
    • Civil Defense Approval: Obtain approval from the General Directorate of Civil Defense.
    • Interior Design: The store must have a spacious and suitable design for displaying products, with adequate lighting and proper ventilation.
  • Specialized Staff:
    • Technical Manager: The store’s technical manager must be a Saudi national, an optician or optometry specialist, with a valid professional classification from the Saudi Commission for Health Specialties.
    • Technical Staff: All working technicians must hold a valid professional classification.
  • Equipment and Facilities:
    • Examination Devices: Provide essential eye examination devices, such as a Phoropter and a Lensometer.
    • Assembly Tools: Provide tools and equipment for assembling lenses into frames.
    • Products: All eyeglasses and contact lenses must be registered and licensed by the Saudi Food and Drug Authority.
  • Additional Requirements:
    • Insurance Policy: Obtain an insurance policy against professional errors.
    • Regulatory Compliance: The store must comply with all regulations and rules of the Ministry of Health and the Saudi Food and Drug Authority, especially regarding the sale and manufacture of contact lenses.