Get Pharmaceutical Establishment License

Special conditions

• He cannot be a partner in more than one pharmaceutical institution The owner or partner must be of Omani nationality and not less than the legal age
• To license the opening of a public pharmacy, the following conditions must be met: 1. The distance between the pharmacy to be licensed and the nearest health institution must be at least 100 meters, measured from the midpoint of the main entrance of each. 2. The distance between the pharmacy to be licensed and the nearest public pharmacy must be at least 200 meters, measured from the midpoint of the main entrance of each, except for pharmacies licensed within commercial complexes. 3. It must be located on the ground floor of the building and on one of its external facades, except for pharmacies within commercial complexes, provided that an internal architectural drawing of the pharmacy is submitted. 4. Its floor must be elevated above the level of the ground facing it, except for pharmacies licensed within commercial complexes. 5. Its internal area must not be less than 24 square meters. 6. It must not be internally connected to a residence or another shop.
• To license the opening of a inhouse pharmacy, the following conditions must be met: 1. It must be inside the private hospital. 2. Its internal area must not be less than 20 square meters.
• To obtain a license to open a pharmaceutical warehouse, the following requirements must be met: 1. The building and roof must be made of reinforced concrete or a similar non-combustible material according to the safety and security standards set by the General Authority for Civil Defense and Ambulance. 2. The internal area must be at least 60 square meters, and the ceiling height must be at least 3 meters, with an internal architectural plan provided. 3. The warehouse floor must be made of a solid, easy-to-clean material and must not be lower than the level of the public road or the adjacent or facing ground. 4. The walls and ceilings must be painted with an easy-to-clean paint, and the paint must be reapplied whenever necessary
• To obtain a license to open pharmaceutical factories: 1. Fulfill the conditions outlined in the licensing guide for human and herbal medicine factories, medical devices, and supplies issued by the directorate. 2. Adhere to the principles of good manufacturing practice (GMP) according to the Gulf Cooperation Council (GCC-GMP) guidelines and the World Health Organization (WHO-GMP) guidelines. Scientific Office: 1. It should not be part of another pharmaceutical institution, except for a pharmaceutical factory. 2. It must be equipped with appropriate air conditioning, lighting, ventilation, and a refrigerator for storing drug samples that require cooling. 3. There should be a designated area for storing drug samples that do not require cooling, according to the specified conditions. 4. It must have the necessary equipment and scientific references to perform its functions. 5. It should be equipped with safety and security measures according to the requirements of the General Directorate of Civil Defense and Ambulance.
• Pharmaceutical Consulting Office: 1. It should not be part of any other pharmaceutical institution. 2. It must be equipped with appropriate air conditioning, lighting, and ventilation. 3. It must have the necessary equipment and scientific references to perform its functions. 4. It should be equipped with safety and security measures according to the requirements of the General Directorate of Civil Defense and Ambulance. 5. The office manager must be a full-time Omani pharmacist. Drug Analysis Laboratories: 1. The floors and walls should be made of non-flammable materials that do not react with chemicals and are easy to clean. 2. Its sections should be separated in a way that prevents and limits contamination. 3. It should have a secure place for storing controlled substances. 4. It must adhere to the good laboratory practice (GLP) principles for drug analysis laboratories according to the World Health Organization (WHO-GLP) guidelines. 5. Sensitive equipment should be in separate, independent rooms to avoid interference from other devices.