Comprehensive oversight of pharmaceutical production and cultivation of narcotic plants
- Prohibit the use of narcotic drugs except in procedures authorized by the Ministry.
- Obligate factories to document materials, receipts, disbursements, quantities, and receiving entities.
- Report to the local police station and the Pharmaceutical Inspection and Licensing Administration in the event of any lost package.
- Store seeds and plants in secure locations to prevent leakage or unauthorized use.
- Enclose cultivation sites with fencing and security guards, and prohibit entry by unauthorized persons.
As part of the Ministry of Health’s efforts to implement an integrated supervisory system for the production, manufacturing, and cultivation of narcotic substances used for medical purposes, the Minister of Health issued two ministerial regulatory decisions, establishing comprehensive supervisory controls for licensing, production, cultivation, storage, and documentation.
The decision restricts the production or manufacturing of these substances to pharmaceutical factories licensed by the Ministry of Health, and prohibits their use except in procedures authorized by the Ministry. It requires the submission of a set of documents, most notably trading licenses, production licenses, and Good Manufacturing Practice (GMP) certificates, as well as specifying the type and quantities of materials used and identifying the pharmacist responsible for their custody.
The decision obligates factories to document receipt and disbursement operations in official registers and vouchers containing details of the materials, quantities, receiving entities, and responsible officials. Registers, disbursement vouchers, purchase invoices, and licenses must be retained for three years.
It also stipulates that the custodian must be a pharmacist licensed in Kuwait, and that narcotic drugs and psychotropic substances must be stored in securely locked safes. Physical inventory counts of stock levels must be conducted, and custody transfer operations must be documented.
In cases of breakage or loss, the decision mandates immediate reporting to the competent authorities. If any package or quantity of these substances is lost, the local police station and the Pharmaceutical Inspection and Licensing Administration must be notified, and a report on the incident must be submitted to the General Administration of Legal Affairs within 48 hours.
The decision sets the license validity period at two years, with renewal applications required one month prior to expiration. It also obligates factories to submit quarterly reports detailing incoming, disbursed, and remaining quantities.
The decision permits government entities, research centers, and licensed public and private universities, colleges, and specialized institutes to cultivate narcotic plants listed in Table No. 5 of the First Group attached to Law Decree No. 159 of 2025, provided they obtain a license from the Minister of Health and use them solely for medical or research purposes.
The decision obligates the custodian, who must be a pharmacist licensed in Kuwait, to record all receipt and disbursement operations, remaining quantities, and to retain registers, disbursement vouchers, purchase invoices, and licenses for three years. Unused or expired seeds must be returned to the originating entity.
The decision further requires that seeds and plants be stored in secure, tightly sealed locations to prevent leakage or use outside the licensed purpose. Upon completion of the cultivation purpose or cancellation of the license, the crop and remaining seed quantities must be destroyed in the presence of a committee from the Ministries of Health and Interior.
The ministerial decision regulating licenses for the production and manufacturing of drugs and preparations containing narcotic or psychotropic substances grants authorized Ministry of Health staff the authority to inspect materials, registers, and documents at production factories. It also authorizes the Minister of Health or their delegate to cancel or refuse a license whenever necessary.
The ministerial decision concerning the conditions and controls for cultivating narcotic plants for medical purposes and scientific research stipulates that in the event of any lost seeds or plants, the local police station and the Pharmaceutical Inspection and Licensing Administration must be notified, and a report on the incident must be submitted to the General Administration of Legal Affairs within 48 hours.
It also set the license validity period at two years, requiring renewal applications to be submitted before expiration, and mandated license holders to submit quarterly reports on quantities used and remaining to the Ministry of Health.
