Reimbursed Care Access in Bosnia and Herzegovina

Currently classified as a strictly controlled psychotropic substance under Bosnia and Herzegovina’s narcotics/psychotropic substance framework, with no authorized medical use outside of approved clinical research. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. #

Esketamine (branded product Spravato) is an internationally licenced medicine for treatment‑resistant depression in some jurisdictions (for example the European Medicines Agency has an EPAR for Spravato). # The national regulator in Bosnia and Herzegovina responsible for marketing authorization and reimbursement for medicines is the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBiH). There is no published evidence on the ALMBiH website of a domestic marketing authorisation, national reimbursement listing, or a public Spravato administration program in Bosnia and Herzegovina as of the time of this report; therefore Spravato cannot be considered an approved, publicly reimbursed treatment there. #

Clinical / reimbursement implications (Bosnia and Herzegovina):
- Regulatory body: the ALMBiH is the competent national medicines authority for marketing authorisation decisions and for producing the regulatory framework that would enable a novel antidepressant product to be licensed or reimbursed. #
- International context: Spravato has EU regulatory documentation (EMA) and major‑market approvals which outline REMS‑style or restricted distribution programs and administration requirements in certified healthcare settings; those programs are country‑specific and do not automatically create rights of use in non‑EU countries. #
- Reimbursement: there is no public evidence that Spravato is on Bosnia and Herzegovina national reimbursement lists or that entity health insurers reimburse esketamine for psychiatric indications; absent a local marketing authorisation and pricing/reimbursement negotiation, Spravato would not be routinely available or reimbursed in the public system. #

Ketamine is a long‑standing, internationally recognised anesthetic and analgesic used in human medicine and appears on the WHO Model List of Essential Medicines for injectable anaesthetics, which underpins its routine availability for medical uses globally. #

In Bosnia and Herzegovina the national medicines regulator (the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, ALMBiH) is responsible for oversight of medicinal product availability, importation and national regulation; generic ketamine formulations that are used as anesthetics and analgesics would be regulated as authorised medicinal products by that agency or by entity‑level implementation under its framework. #

Clinical and reimbursement nuance:
- Medical use: Ketamine is routinely used as an anesthetic/analgesic in surgical, emergency and obstetric settings worldwide and is included on the WHO essential medicines list, supporting legitimate hospital‑based availability. #
- Off‑label psychiatric use: In many countries clinicians employ racemic ketamine off‑label for treatment‑resistant depression in specialist settings; such off‑label psychiatric use typically requires specialist mental‑health services, local institutional approval, and informed consent because the indication is off‑label and reimbursement varies widely. In Bosnia and Herzegovina there is no documented national program for reimbursed ketamine treatment for depression, and available evidence does not indicate routine public reimbursement for ketamine used for psychiatric indications. Regulatory oversight and reimbursement for off‑label psychiatric administration would rest with hospital formularies, entity health authorities and payer rules in the Federation and Republika Srpska; no national reimbursement guidance specific to ketamine for TRD was identified on ALMBiH public pages. #

Practical consequence: ketamine as an anaesthetic is an accepted medical product and likely available in hospitals in Bosnia and Herzegovina; ketamine for psychiatric indications (IV infusions, KAP) would be considered off‑label, delivered at institutional discretion, and is unlikely to be routinely reimbursed by public health insurers absent specific local programs or pilot rollouts.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. Note: internationally ibogaine’s legal status varies and in many countries it sits in a legal grey zone, but in Bosnia and Herzegovina there is no authorised medical pathway. # #

The active primary compound in ayahuasca preparations (DMT) is a controlled psychotropic substance in Bosnia and Herzegovina; there is no authorised medical use for ayahuasca and no routine reimbursement or legal sacramental exemption documented. Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. (Synthetic phenethylamine '2C‑' series compounds are widely controlled internationally and are treated as illicit substances in Bosnia and Herzegovina). #