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Agreed deadline for amendments to the regulations on cannabis-based medicines and preparations

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Agreed deadline for amendments to the regulations on cannabis-based medicines and preparations

The Ministry of Civil Affairs of Bosnia and Herzegovina organized a meeting due to the lack of concrete progress in the implementation of the conclusions from the round table on the use of cannabis for medical purposes, held on April 23, 2026.

The meeting was attended by representatives of the Ministry of Civil Affairs of Bosnia and Herzegovina, the Federal Ministry of Health, the Agency for Medicines and Medical Devices of Bosnia and Herzegovina, the Chamber of Masters of Pharmacy of the Federation of Bosnia and Herzegovina, the Chamber of Pharmacy of the Republic of Srpska, the Association of Child Neurologists in Bosnia and Herzegovina, the House of Representatives of the Parliament of the Federation of Bosnia and Herzegovina and patients.

The goal of the meeting was to determine the reasons for the lack of progress, review the state of implementation of the adopted conclusions and redefine further activities. Although all competent institutions and professional organizations expressed their readiness to contribute to the completion of the process at the round table in April 2026, it was determined at the meeting that since the round table, no concrete activities have been undertaken to prepare and introduce amendments to the rulebook regulating the conditions for prescribing and issuing cannabis-based drugs and preparations.

We remind you that on December 29, 2025, at the proposal of the Ministry of Civil Affairs of Bosnia and Herzegovina, the Council of Ministers of Bosnia and Herzegovina unanimously passed the Decision on Amendments to the List of Narcotic Drugs, which removed the fundamental legal obstacle to the use of cannabis for medical purposes.

During the meeting, the importance of the urgent adoption of amendments to the Rulebook on the conditions for prescribing and dispensing medicines in the retail trade, which would regulate the indications for the use of cannabis-based medicines and preparations, the specialties of medical doctors authorized to prescribe them, registers of doctors and patients, doses, pharmaceutical forms and the method of dispensing through the health system, was again emphasized.

Adoption of this rulebook is the responsibility of the Federal Ministry of Health.

Assistant to the Minister Jurica Arapović reminded that changes to the rulebook in question were also discussed at the session of the Conference of Ministers for Health in Bosnia and Herzegovina, held on April 8, 2026, when the Federal Ministry of Health confirmed that it is necessary to change the entity by-laws that determine the prescription and dispensing of drugs containing narcotic drugs.

Representatives of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina warned that the absence of the regulation in question makes it impossible for Bosnia and Herzegovina to fulfill its obligations towards the International Narcotics Control Board (INCB). Namely, without a clearly defined system of prescription and distribution, it is not possible to submit an assessment of Bosnia and Herzegovina’s annual needs for drugs and preparations based on cannabis, which is a prerequisite for approving their import and availability to patients.

Representatives of the Association of Pediatric Neurologists in Bosnia and Herzegovina once again stressed the need to provide access to appropriate therapy as soon as possible for patients, especially those with drug-resistant epilepsy and other medical indications for which cannabis-based drugs and preparations have been used in numerous European countries for years.

The establishment of an appropriate regulatory framework would also enable the pharmaceutical chambers to begin drafting harmonized master formulations for the Federation of Bosnia and Herzegovina and the Republika Srpska without delay.

One of the key conclusions of the meeting is that by August 1, 2026, the Federal Ministry of Health will prepare a draft of amendments to the Rulebook on the conditions for prescribing and dispensing drugs in the retail trade.

In order to harmonize the professional solutions that will be included in the draft, the Federal Ministry of Health will organize a coordination meeting with representatives of relevant associations and experts in the fields of oncology, neurology, pediatric neurology, infectology and anesthesiology in the next 15 days.

The Ministry of Civil Affairs of Bosnia and Herzegovina will continue, within its competences, to monitor the implementation of the agreed conclusions with the aim of establishing a regulatory framework that will ensure the safe, controlled and professionally based application of drugs and preparations based on cannabis and provide patients with timely access to therapy in cases where there are medical indications for it.

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