Shortage of Galenika Testosterone Expected Until Early July

Recently, in response to a renewed shortage of Galenika’s product, Testosterone Depo ampoules, we contacted both Galenika and the Ministry of Health, requesting information on how long this shortage would last and why such issues are occurring more frequently. We also highlighted the importance of the continuous availability of hormone therapy, as well as the serious consequences that shortages have for all people who use this treatment, including trans men and transmasculine individuals, as well as many others.

We are reproducing the Ministry of Health’s response in full:

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Dear Sir/Madam,

Regarding your inquiry concerning the interruption in the supply of the medicinal product Testosteron Depo (250 mg/mL; solution for injection), from the perspective of the competence of this Sector, we inform you of the following:

Based on information received from the manufacturer and marketing authorization holder, Galenika a.d. Belgrade, occasional interruptions in the availability of the medicine in pharmacies occurred due to an unexpected depletion of stocks that were primarily intended and reserved for the needs of healthcare institutions at the hospital level. Although the planned quantity was projected to meet the system’s needs until the next tender cycle, a significant portion of these quantities was distributed through other sales channels, resulting in a current shortage in retail pharmacies.

According to the official notice from the manufacturer, regular resupply of Testosteron Depo is expected at the beginning of July 2026, following the completion of a new tender procedure and stabilization of the production cycle.

Regarding your statements about difficulties in obtaining the medicine via prescription in pharmacies, as well as the exercise of the right to therapy outside the place of residence, we note that the regulation of prescribing and dispensing medicines covered by compulsory health insurance, as well as the establishment of the List of Medicines, falls under the exclusive jurisdiction of the Republic Health Insurance Fund (RFZO). Issues related to the availability of medicines in pharmacies contracted with the Fund, as well as the resolution of individual patient requests in this area, are within the scope of the RFZO and its branch offices.

As appropriate therapeutic alternatives available on the market of the Republic of Serbia, for which the Agency for Medicines and Medical Devices of Serbia has issued marketing authorizations, we note the following medicine: Androgel, transdermal gel (16.2 mg/g).

We emphasize that patients must consult their specialist physician (endocrinologist) regarding the choice and introduction of replacement therapy, who will determine the appropriate dosage during the transition period.

Thank you for your understanding and cooperation.

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We subsequently also received a response from Galenika, stating that Testosteron Depo is expected to be available in healthcare institutions from May 20.