Please ensure Javascript is enabled for purposes of website accessibility Pharmaceutical Facility License & Medical Device Establishments Approval Pharmaceutical Facility License & Medical Device Establishments Approval

Pharmaceutical Facility License & Medical Device Establishments Approval

Pharmaceutical Facility License & Medical Device Establishments Approval

Service Provider

Drug Safety Center

Target Audience

Business owners 

Service Delivery Channels

E-Health portal

Service Completion Period

It depends on adhering to the requirements and employing employees of the Pharmaceutical Corporation

Details

This service enables you to get a license to open a pharmaceutical facility, including: a public pharmacy, internal pharmacy, drug warehouse, a scientific office, pharmaceutical consulting office, drug analysis laboratories, pharmaceutical studies center, or a pharmaceutical factory.& Medical Device Establishments Approval

Service Steps

The location in which the establishment is to be opened

Terms and Conditions
  • Adherence to the conditions to open a pharmaceutical institution (available on the Ministry's website)
  • It could not be a partner in more than one pharmaceutical institution
  • That the owner or partner be Omani nationality and not less than the legal age
  • For Local Medical Device Establishment approval conditions are as below:
  • Store Requirements for Medical Devices and Supplies:
    General Requirements:
    1. Correct positioning of the package/container
    2. Maximum number of packages that can be stacked on top of each other.
    3. Provide tools to measure temperature and humidity levels, with continuous
    monitoring and adjustment based on the manufacturer’s instructions. Temperature
    measurement tools must be connectable and readable, with suitable readers
    provided.

    4. Provide adequate lighting and ventilation, and maintain cleanliness in the area.
    5. The building and roof must be made of reinforced concrete or a similar non-
    combustible material, in accordance with safety and security regulations issued by
    the competent authority.

    6. Air conditioning must be suitable for the storage area.
    7. Provide an emergency plan or an automatic backup generator to ensure continuity
    of power supply to devices requiring refrigeration.

    8. Implement an inventory tracking system that monitors stored and sold medical
    devices, with regular inventory checks to track expiration dates and prevent
    distribution of expired products.

    9. Provide appropriate measures to eliminate rodents and insects, and use proper
    sealed containers for waste.

    10. Equip the facility with licensed safety and security systems as required by the
    relevant authorities.

    11. Allocate a designated area for isolating damaged, expired, or rejected medical
    devices and supplies, with clear labeling and monitoring until proper disposal.

    12. Contract with a specialized company for disposal of damaged and expired supplies,
    in accordance with Drug Safety Center requirements.

    13. Report any incidents or adverse events elated to stored devices to the relevant
    authorities

    14. The storage area and its internal layout must be appropriate for the types,
    categories, and sizes of the medical devices stored, ensuring easy access and
    proper, safe storage without overcrowding or stacking that

    Storage Requirements for Medical Devices and Supplies for Wholesaling
    of Medical Goods, Tools and Surgical Devices and Orthopedic Devices:

    1. Comply with the general requirements listed above.
    2. Prepare written procedures outlining proper practices for transportation and storage,
    and train staff accordingly.

    3. If the device/product label does not include storage, transportation, or handling
    instructions, the facility must contact the manufacturer to obtain them.
Fees Details

-Pharmaceutical factory license 1500 riyals

-Pharmaceutical warehouse license 450 riyals

-Pharmaceutical analysis laboratory license and pharmaceutical studies center license 600 riyals

-Pharmaceutical consulting office license 300 riyals

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