Al-Awadhi issues a decision regarding the regulations and procedures for licensing private sector pharmacies

Kuwait’s Minister of Health, Dr. Ahmed Al-Awadi, issued a ministerial decision today, Wednesday, regarding the regulations and procedures for licensing pharmacies in the private sector and the trading of medicines and medical products therein. The Ministry of Health stated in a press release that the decision includes a comprehensive regulatory framework for the various 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 ministry clarified that the decision sets specific controls for licensing private pharmacies, whether for Kuwaiti pharmacists, cooperative societies, or private hospitals. It also stipulated that the validity period of a private pharmacy license is four years, and organized procedures for issuing, renewing, changing the location or area, adding warehouses, temporary or permanent closure, and re-opening pharmacies, along with related requirements, inspections, and approvals from competent authorities.

It added that the decision requires 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 exceptions for certain sites and facilities mentioned in the decision.

The ministry pointed out that the decision emphasized 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 ranging between 2 and 8 degrees Celsius.

The ministry noted that the decision obliged pharmacy license holders to appoint a licensed pharmacy manager who is not permitted to manage more than one pharmacy. It defined the manager’s responsibility for the operation of the pharmacy, custody of medicines, invoices, prescriptions, records, technical aspects, and staff. Furthermore, it mandated that pharmacies owned by companies, individuals, cooperative societies, and private hospitals, whose licenses were issued to non-Kuwaiti pharmacists, must appoint at least one Kuwaiti pharmacist holding a valid professional practice license.

The ministry indicated that the decision regulated the operation of pharmacies through night shifts and 24-hour opening hours. It also specified the essential data that must be present on a medical prescription before dispensing, and prohibited the trading, dispensing, or selling of medicines, health products, dietary supplements, herbal preparations, and special foods if the remaining shelf life is less than 30 days.

It affirmed that the decision prohibits the acceptance or return of medicines, health products, dietary supplements, herbal preparations, and special foods after they have been dispensed or sold to the public in private pharmacies. It also required that products displayed or sold be in their original packaging approved for circulation by the competent authority within the Ministry of Health.

The ministry mentioned that the decision included regulations for external advertising on the facades of private pharmacies, requiring prior approval from the competent authority within the Ministry of Health. It also established detailed controls for the settlement of custody of medicines and medical products in the event of temporary or permanent closure of a pharmacy.