Al-Awadi: Private pharmacy licenses subject to regulations and procedures
Minister of Health Dr. Ahmed Al-Awadi issued a ministerial decision regarding the regulations and procedures for licensing pharmacies in the private sector, as well as the trading, dispensing, and storage of medicines and medical products therein. The Ministry of Health stated in a press release that the decision includes a comprehensive regulatory framework covering all stages of licensing and operating private pharmacies, as well as mechanisms for trading, dispensing, storing, and delivering medicines, alongside the organization of professional and supervisory responsibilities for personnel working in these facilities.
The decision specifies regulations for licensing private pharmacies, whether for Kuwaiti pharmacists, cooperative societies, or private hospitals. It sets the validity period of a private pharmacy license at four years and organizes procedures for issuing, renewing, relocating, or expanding the pharmacy’s area, adding warehouses, temporarily or permanently closing the pharmacy, and reopening it, along with associated requirements, inspections, and approvals from competent authorities.
The decision mandates a minimum distance of 1,000 meters in all directions between a pharmacy seeking a license and the nearest existing pharmacy, according to a specified measurement mechanism, with certain exceptions for sites and facilities listed in the decision. It also emphasizes the technical and health requirements necessary for the preservation and storage of medicines and medical products, including that the temperature inside the pharmacy and its warehouses must not exceed 25 degrees Celsius, and that medicines requiring refrigeration must be stored at temperatures between 2 and 8 degrees Celsius.
The Ministry noted that the decision obliges the license holder of a pharmacy to appoint a licensed pharmacy manager who is not permitted to manage more than one pharmacy. It defines the manager’s responsibility for operations, custody of medicines, invoices, prescriptions, records, technical aspects, and pharmacy staff. Furthermore, it requires private pharmacies owned by companies, individuals, cooperative societies, and private hospitals licensed to non-Kuwaiti pharmacists to appoint at least one Kuwaiti pharmacist holding a valid professional practice license.
The decision regulates the operation of pharmacies through night shifts and 24-hour opening hours. It specifies the essential data that must be present on a medical prescription before dispensing and prohibits the trading, dispensing, or sale of medicines, health products, dietary supplements, herbal preparations, and specialized foods if their remaining shelf life is less than 30 days.
The decision stipulates that pharmacies are not permitted to accept or take back medicines, health products, dietary supplements, herbal preparations, and specialized foods after they have been dispensed or sold to the public. It also requires that products displayed or sold be in their original, approved packaging as authorized by the competent authority within the Ministry of Health.
Additionally, the decision regulates external advertising on the facades of private pharmacies and requires prior approval from the competent authority within the Ministry of Health. It establishes detailed regulations for the disposal of medicines and medical products in the event of temporary or permanent closure of a pharmacy.
