Minister of Health: Comprehensive regulation of pharmacy licensing procedures in the private sector and mechanisms for the trade, dispensing, storage, and delivery of medicines

Abdul Karim Al-Abdullah: Minister of Health Dr. Ahmed Abdulwahab Al-Awadi has issued Ministerial Decision No. (235) of 2026 concerning the regulations and procedures for licensing pharmacies in the private sector and the trading of medicines and medical products therein. The decision includes a comprehensive regulatory framework for the various stages of licensing and operating private pharmacies, as well as mechanisms for the trading, dispensing, storage, and delivery of medicines, alongside the organization of professional and supervisory responsibilities for personnel working in these facilities.

The decision sets specific controls for licensing private pharmacies, whether for Kuwaiti pharmacists, cooperative societies, or private hospitals. It stipulates that the validity period of a private pharmacy license is four years, and organizes the procedures for issuing, renewing, changing the location or area, adding warehouses, temporary or permanent closure, and re-opening of pharmacies, along with the associated requirements, inspections, and approvals from competent authorities.

Among the most prominent provisions is the requirement that the distance between a pharmacy seeking a license and the nearest existing pharmacy must not be less than 1,000 meters in all directions, according to a specified measurement mechanism. This is subject to exceptions for certain sites and facilities mentioned in the decision, including pharmacies located in cooperative societies and similar central markets, commercial complexes, airports, universities, and private hospitals, as well as buildings licensed as clinics or medical centers according to specified conditions.

The decision organized a mechanism for regularizing the status of existing pharmacies upon renewal or relocation in light of the distance requirement. Priority is determined based on the date of issuance of the first license to conduct business at the current location, with clear controls for dealing with newer pharmacies. A pharmacy issued a relocation order is granted a three-month period to select an alternative site and complete relocation procedures, with the possibility of renewal for a similar duration.

The decision also emphasized the technical and health requirements necessary for the preservation and storage of medicines and medical products. This includes ensuring that the temperature in the pharmacy and its warehouses does not exceed 25 degrees Celsius, and that medicines requiring refrigeration are stored at temperatures between 2 and 8 degrees Celsius. Furthermore, it regulates storage methods and the safe isolation of expired medicines, as well as the storage of narcotic, psychotropic, and mind-altering drugs in securely locked cabinets according to approved controls.

Regarding professional practice, the decision obliged the license holder 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, the custody of medicines, invoices, prescriptions, records, technical aspects, and staff. Additionally, it mandated that pharmacies owned by companies, individuals, cooperative societies, and private hospitals licensed to non-Kuwaiti pharmacists must appoint at least one Kuwaiti pharmacist holding a valid practice license.

The decision established a more detailed system for documenting the attendance and departure of pharmacists and pharmacy technicians, either through paper records or an electronic system. Pharmacies are required to provide the competent authority with a monthly report on the working days and times of practitioners, and to regulate procedures for leave, resignation, and the appointment of replacements, thereby enhancing the clarity of professional responsibilities and the continuity of licensed staff presence.

The decision also regulated the operation of pharmacies on night shifts and 24-hour opening, requiring prior approval from the Ministry of Health and meeting specific requirements, including employing at least three pharmacists in addition to the license holder. Such approval is valid for one year and renewable upon compliance with the conditions.

In a dimension directly related to patient safety, the decision specified the basic data that must be present in a medical prescription before dispensing, including patient and doctor details, medication name, dosage, treatment duration, and method of use. It mandated verifying the patient’s identity and ensuring the prescription is free from conflicts and medication errors. The pharmacist is granted the right to object to or refuse dispensing a prescription that does not meet the stipulated conditions and data.

The decision also prohibited the trading, dispensing, or sale of medicines, health products, dietary supplements, herbal preparations, and special foods if the remaining validity period is less than 30 days. It noted that the validity of chronic disease medications and other preparations used for treatment may extend beyond the last prescribed dose, provided it is not less than thirty days.

The decision confirmed that it is not permissible to accept or return 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 at the Ministry of Health.

As a step to enhance safe medication use, the decision obliged the placement of an identification card on the original packaging of every dispensed medicine. This card must include patient details, medication name, dosage, method of use, quantity dispensed, storage instructions, and other specified data, in a language understandable to the patient or their caregiver, with necessary warnings and guidelines added when required.

The decision also regulated the service of delivering medicines and medical products from private pharmacies, requiring prior approval and compliance with specific requirements regarding transport means, temperature preservation, invoices, records, service requester data, and adherence to official pricing. The delivery of substances dispensed only by prescription is prohibited, in accordance with relevant ministerial decisions.

Finally, the decision set detailed controls for the liquidation of medicine and medical product custody upon the temporary or permanent closure of a pharmacy. This includes inventorying narcotic and psychotropic substances, medicines subject to ministerial decisions, and other preparations, and regulating their return to the approved supplier, transfer to a licensed pharmacy, or disposal according to approved controls, while specifying retention periods for related prescriptions.