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
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
The location in which the establishment is to be opened
- 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 position of the package/container.
2. Determine the maximum number of packages that can be stacked on top of each
other, ensuring sufficient shelving is provided to protect medical devices and
supplies, organize storage, prevent damage or contamination, and prevent placing
boxes directly on the floor or excessive stacking.
3. Products must not be stacked up to the store/ warehouse ceiling.
4. Ensure that all products includes labelling in English or Arabic if the product is
intended for home use.
5. Availability of measuring temperature and humidity device, with continuous
monitoring and adjustment according to the manufacturer’s instructions. The
measuring devices must be connectable and readable, with the appropriate reader
available.
6. Provide adequate lighting and ventilation, ensuring products are kept away from
direct sunlight and that the area remains clean.7. The building and roof must be constructed from reinforced concrete or other non-
combustible material in accordance with safety regulations prescribed by thecompetent authority.
4. Availability of official means of communication: an active landline phone and an
8. Air conditioning must be appropriate for the storage space.
9. Provide an emergency plan or an automatic backup generator in case of power
failure, especially for devices requiring refrigeration.
10. Provide measures for pest and rodent control, along with proper sealed containers
for waste.
11. Equip the store/ warehouse safety and security systems licensed in accordance
with the requirements of the competent authorities.
12. Contract with a specialized company for the disposal of damaged and expired
supplies, in accordance with the Drug Safety Center requirements, and ensure that
the company retains disposal records.
13. Allocate a clearly marked and monitored area to isolate damaged, expired, or
rejected medical devices and supplies until their final disposal.
14. Floors must be solid, easy to clean, and level with the road.
15. Walls and ceilings must be painted with suitable coating and repainted when
necessary.
16. Accidents or issues related to stored devices must be reported to the competent
authorities.
Storage Requirements for Medical Devices and Supplies for Wholesale Activity of
medical goods, tools, surgical devices, and orthopedic devices:
1. Compliance with the general requirements (listed above).
2. Availability of a valid and updated commercial registration and trade license in the
store/ warehouse.
3. Availability of the Establishment official stamp in the store/ warehouse.
official email address for the establishment.
5. The establishment, including the store/ warehouse, must operate during working
hours specified by the Drug Safety Center, from 8:00 a.m. to 1:00 p.m.
6. The establishment must update the store’s/ warehouse’s geographical location on
Google Maps.
7. Each store/ warehouse is required to obtain a municipal license for wholesale
activity and display a signboard identifying the store/ warehouse, in accordance
with specifications approved by the Drug Safety Center.
8. Medical devices and supplies must not be stored in apartments.
9. Spaces must be divided into: receiving area, dispatch area, storage area, with
separate designated areas for damaged products and expired products.
10. A digital system must be available to record inventory data, including batch
number, manufacturer’s details, and other relevant information, ensuring
traceability of product movement from receipt to distribution, with specific
classification for recalled, damaged, and expired products.
11. Written procedures must be prepared to clarify practices to be followed for
proper transport and storage. Employees must be trained to ensure storage and
transport are carried out in accordance with the manufacturer’s instructions,
including requirements related to temperature, humidity, light exposure, and
other conditions depending on the product’s nature.
12. The store/ warehouse must have designated entrances and exits for
loading/unloading, as well as emergency exits.
13. An administrative office must be available within the store/ warehouse.
14. If the product/device label does not include instructions or statements regarding
storage, transport, or handling conditions, the establishment must contact the
manufacturer to obtain them.
15. The store/ warehouse must obtain the necessary approvals from Medical Device
Control Department.
16. The transportation of medical devices and supplies shall be carried out through
suitable and safe means of transport, which must be appropriately equipped in
accordance with the nature of the devices being transported.
-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